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DIA's highly rated instructor-led training courses are designed to inform and educate professionals and experts on critical issues related to pharmaceuticals, biotechnology, and medical products.
Courses on more than 50 topics provide professionals from industry, government, and academia with the opportunity to exchange ideas, knowledge, and best practices with peers and expert instructors. Courses offered range from European regulatory affairs to drug development to safety inspection preparation.
In addition to expert instruction, each course participant receives a comprehensive set of lesson materials that is consistent across courses.Review the list of courses below to get more information on:
- What You will Learn in Pharmaceutical, Biotechnology, Medical Devices, and Related Areas
- Specific Learning Objectives
- Target Audiences
- Contact Information
Adaptive Design in Clinical Trials: When and How to Apply
There has been a considerable interest and increase in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010. Adaptive design has the potential to reduce the cost and length of drug development, and/or improve the probability of success and de-risk drug development. However, there is a lot of uncertainty and questions around the use of adaptive design. In this course we will identify opportunities in early and late phase development where adaptive design may be applied, and use practical examples to demonstrate how to appropriately design and implement such trials in consensus with FDA Guidance.
Course Level: Beginner/Intermediate
Course level:TRNG
Advanced GCP Study Monitoring
Clinical Research Monitors perform a critical role in the conduct of a clinical trial. As the primary liaison between the sponsor and the site, the monitor must verify that the clinical trial is conducted according to Good Clinical Practice, the safety and rights of subjects are protected, the Investigational Medicinal Product is handled correctly and the data is of the highest quality. This course will expand and strengthen the monitoring skills of Clinical Research Associates, enabling them to perform their role
more proficiently and effectively.Using case studies, monitors will learn how to handle monitoring problems and proactively manage risks
before they become audit findings later. This course includes an invaluable "shared experience session" which will enable colleagues to discuss monitoring challenges they face.
- Research misconduct
- Risk Management for the Monitor
- Elements of Corrective and Preventive Action Plans
- Advanced Monitoring Techniques and Tools
- Benchmarking for site performance evaluation
- Source document/data evaluation
- Electronic source data verification
Course level:TRNG
Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation
Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities. Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. This basic to intermediate level course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on practical exercises and discussions.
Course level:TRNG
Advanced Workshop on QPPV Tool Box - Your Key to Success
The workshop is designed to include small group interaction and discussions, led by our expert instructor, and is based on suggestions from the QPPVs themselves. The workshop will allow you to be more efficient in solving the problems in your daily business, learn the right thinking processes to land at good results and hear from solutions from other in similar situations.
Course level:TRNG
Advanced Workshop on QPPV Tool Box - Your Key to Success
The workshop is designed to include small group interaction and discussions, led by our expert instructor, and is based on suggestions from the QPPVs themselves. The workshop will allow you to be more efficient in solving the problems in your daily business, learn the right thinking processes to land at good results and hear from solutions from other in similar situations.
Course level:TRNG
An Introduction to Product Information Management
PIM is a new method of submitting product information in the Centralised Procedure (CP). With more than 20 different languages in the EU leading to 1000 or more documents for a single trade name, there is an increased burden on applicants and authorities to handle information for packaging leaflets and product characteristics, especially during the time critical translation process. PIM has been introduced by the EMEA to increase efficiency during exchange of product information and improve the quality and constancy of product information.
This training course is designed to give the participants a good understanding about Product Information Management, the PIM submission process and variations, the translation process and comment handling as well as the exchange standard and templates used.
- PIM Essentials
- Initial Submissions
- Comment Handling
- Translation Process
- PIM Variations
- LAT – The Light Authoring Tool
Course level:TRNG
Art of Writing a Clinical Overview
DIA is pleased to present this introductory training course which will provide an in-depth analysis of the preparation of a Clinical Overview for pharmaceutical products (drugs and biologics) in accordance with ICH guidelines concerning development of Module 2.5 of a Common Technical Document (CTD).
Course level:TRNG
Basics of the IND Phase
DIA is pleased to present a four-part course in which you will learn about FDA regulations and expectations for the content, submission, and review of Investigational New Drug (IND) Products and the importance of regulatory strategy. This online course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, OTC products, or traditional biologics.
Course level:TRNG
Basics of the NDA Phase
This training course will discuss the aspects of New Drug Application (NDA) preparation. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.
Course Level: Beginner
Course level:TRNG
Benefit-Risk Management
This intensive course explores current opportunities made possible by the legislation, advances in information technology and new scientific methodology to enhance and modernise the approaches in the product lifecycle management.
The course starts with the current regulatory thinking about the Benefit-Risk methodology, including the relevant projects of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP). It gives a basis for the second part of the course, exploring the new European Benefit-Risk management planning – a notion stemming from the experience gathered over the past ten years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of the efficacy follow-up options given by the EU law and guidelines. A practical training in solving key aspects of the Benefit-Risk management based on real-life examples is included.
Participants will be provided with preparatory material in order to better participate at the group exercises onsite.
Course level:TRNG
Biosimilar Development: Strategies and Regulatory Requirements for Global Market Entry
Do you have a strategy for biosimilar development? Extensive use of biologic products have become the mainstay in personal treatment regimens across an ever increasing array of disease states including cancer, diabetes, various forms of arthritis, Chron's disease and multiple sclerosis. The prohibitive cost of these novel biopharmaceuticals have restricted broader introduction to populations across the globe. Patent expirations for these biopharmaceuticals offer new opportunities to introduce cost effective alternatives to a greater number of patients.
These follow-on biologics have garnered great interest for their cost-effective benefits in patient care as well as development opportunities for sponsors who see a new revenue stream. However, the pathway to commercialization is complicated by regulatory challenges, manufacturing hurdles as well as challenges in understanding the needed data requirements to establish a viable safe and effective product compared to the originator.
This comprehensive, high-level training program will provide a tailored learning experience to those seeking to understand how a follow-on biologic or candidate biosimilar product is developed, regulated and registered for global commercialization. Information will also be provided on remaining issues yet to be resolved that may further complicate successful integration of biosimilars into common therapeutic practice. Information on global market status of follow-on biosimilars, governing regional regulations and pending issues facing further global commercialization will be reviewed.
Course Level: Intermediate
Course level:TRNG
Building the eCTD: Practical Solutions to Compile Electronic Submissions
This course will offer insight into the compilation of the eCTDs, share experience and best practice gained during eCTD submissions and explain the eCTD review und lifecycle process. Especially eCTD submissions in the GCC region will be addressed in detail.
Course level:TRNG
Clinical Aspects of Quality Risk Management and Quality by Design
This course will deliver an in-depth overview of risk-based quality management, including how to assess risk and improve quality within an organisation. As an introduction, general risk management concepts and methodologies will be presented as the basis for Quality Risk Management (QRM) in clinical development and pharmacovigilance. This will be followed by a review of applicable and meaningful metrics for clinical development and pharmacovigilance processes, how these can be best applied, and what change management challenges need to be considered. This is a beginner/intermediate-level course.
Course level:TRNG
Clinical Project Management
The practical hands-on activities in this course will help participants create a custom operations plan for clinical trials. The course covers clinical project management from the planning stage through development, execution, and project close-out.
Course Level: Intermediate
Course level:TRNG
Clinical Project Management in Europe
As clinical trials become more complex and there is increasing demand for efficiency and cost effectiveness, the knowledge and skills required to manage a clinical project are crucial. The course provides a foundation in clinical project management from defining and planning the project to managing, controlling and closing the project. Using an interactive approach based on real case studies, participants will be taught how to apply project management strategies, tools and techniques to their clinical trial projects.
Course level:TRNG
Clinical Statistics for Nonstatisticians
This course answers common questions and addresses topics such as confidence intervals, hypothesis testing, trial designs, and methods for establishing non-inferiority. This course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved.
Course Level: Beginner
Course level:TRNG
Clinical Trial Audits in Practice
This clinical trial audit course is designed to provide training on methods and approaches to plan, conduct and report on different types of audits with examples of practical implementation and discussion of challenges. Recent trends and updates in clinical trial legislation and guidance, increased use of electronic systems in clinical trials as well as implementation of risk management principles are imbedded. The course is a combination of presentations, panel discussions and exercises by an experienced team of auditors and EMA and inspector representatives.
Course level:TRNG
Clinical Trial Management Essentials
This training course provides a comprehensive overview of the essential elements of clinical trial management and the overall drug development process, using real case studies, practical examples and group exercises. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study.
Course level:TRNG
Comprehensive Training on European Regulatory Affairs including Different Registration Procedures and Variations: Expert Overview
The 'Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations: Expert Overview' training course is a key course developed by DIA in Europe. This course provides a comprehensive description and discussion of the regulatory environment. The course focuses on Europe but also looks at regulations in other regions including the USA and Japan.
Your benefit:
This is a unique opportunity to learn, understand and discuss the main aspects of drug regulations in Europe directly from key European Regulators and from the large experience in the pharmaceutical industry and to acquire key recommendations for a successful implementation of your regulatory strategy and operations.
Key Topics:
- Drug regulations
- Role of regulatory affairs in drug - development / approval / marketing
- Efficient interactions between regulatory agencies and the pharmaceutical industry
- Regulatory strategy
- Key differences of international regulatory environments
Course level:TRNG
Developing Standard Operating Procedures
How does a standard operating procedure (SOP) withstand US Food and Drug Administration (FDA) scrutiny? One of the best ways to ensure that an organization meets its business and regulatory obligations is to follow SOPs, which are standardized procedures and processes to ensure that similar tasks are done the same way every time. This online training course explores what SOPs are, their uses, how to write them, their importance to an organization, and how specific SOPs are used in various organizations. Course Level: Beginner
Course level:TRNG
Development of a Clinical Study Report
DIA is pleased to present this fast-track introductory course which is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) guidelines. The reports must meet high quality standards in providing a concise yet comprehensive summary of the study. This course will provide the latest strategies for preparing clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.
Course Level: Beginner
Course level:TRNG
Diagnosis and Management of Drug-Induced Liver Injury (DILI): Clinical Trials and Post-Marketing
This new DIA training course is entirely dedicated to Drug-Induced Liver Injury (DILI). It is led by a Hepatologist with extensive experience in clinical assessment of DILI and who published 'RUCAM' the widely used causality assessment method of DILI. The course will cover the progress that has been made in the clinical detection and prevention of DILI in clinical trials and in post marketing phase. Regulatory guidelines need to be understood for an optimal assessment of DILI cases. Better use of typical tools will be emphasised in order to improve patient safety and drug monitoring in new drug development, especially in large populations. This course will provide tools, explanations, examples and several exercises for a better understanding of DILI and how best to apply that knowledge in day-to-day work.
Course level:TRNG
Electronic Submissions: The Next Era of Electronic Submissions
As part of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the reauthorization of the Prescription Drug User Fee Act (PDUFA V), there will soon be a mandate for the use of electronic submissions, specifically the electronic common technical document (eCTD) in the US. There already exists a mandate in Europe for marketing applications that are eligible for Centralized Procedure review. Electronic submissions are accepted globally in various formats and there are well established standards being used for their creation.
This course will focus on the technical foundations of electronic submissions and their use as well as the practicalities and processes of creating them. The use of technology and the specifications needed for various types of submissions will be presented along with common issues and challenges. The US requirement for the submission of datasets will also be addressed.
Examples of how standards can be employed to generate and track applications will be discussed, and activities on locating current guidance and submission metadata will all be part of this interactive course.
Course Level: Beginner
Key Topics:
eSub/eCTD Guidance, vocabulary and terminology, document and data standards, mapping from regulation to submission
Course level:TRNG
Enterprise Resource Management
Learn how to build, implement, and maintain a resource management business and supporting information technology (IT) system. Understand how to accommodate the reverberations of cultural change and how to get buy-in from all the key stakeholders.
Course Level: Beginner
Course level:TRNG
Essentials and Overview of the Regulatory Framework in Europe
The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. Different steps and timelines for the various procedures will be covered. An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle. In addition, the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed.
The course will cover the current registration systems available for approval of human medicinal products:
- Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
- Directive 2001/83/EC 'the Community Code' on the Mutual Recognition Procedures
A case study will enable participants to apply the freshly gained knowledge into their daily practice.
This is a hands-on course. It is necessary that you bring your laptop/electronic device with you.
Course level:TRNG
Essentials of Project Management
Walk away being able to produce a defensible schedule, a solid staffing plan, and a practical risk response plan in a biotech pharmaceutical/medical device world.
Course Level: Beginner
Course level:TRNG
EU Regulation of In-Vitro Diagnostics
This course will give an overview of the current In-Vitro Diagnostic (IVD) Directive and will highlight anticipated future changes in the regulation. The basic philosophy of the existing system, including the definition of an IVD, will be explained, and borderlines to other products such as medical devices and laboratory equipment will be highlighted. The future IVD Regulation, which is substantially different from the current IVD Directive, will be discussed and major changes will be emphasised. The revised classification rules and the new requirements on performance evaluation will be explained.
The role of IVDs in personalised medicine, the benefit/risk based approach and the market approval for IVDs, which is different from those for medicinal products will be discussed. Differences between the EU and US systems for personalised medicine, and the current and new role of notified bodies, standards and Common Technical Specifications will be addressed.
Exercises will enable you to apply the principles learnt.
Course level:TRNG
Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing
This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
Course level:TRNG
Executing and Controlling Biopharmaceutical Projects
Learn the elements of a project plan, how to use the plan to execute and control a project, and how to motivate team members to exceed the project goals.
Course Level: Beginner
Course level:TRNG
Fundamentals of Clinical Research Monitoring
Interactive lecture and hands-on workshop training methods provide participants with the tools to design and manage clinical studies.
Course Level: Beginner
Course level:TRNG
Fundamentals of Project Management for the Nonproject Manager
This online training course will focus on the basic principles of project management and how they can be applied to best meet the needs of your projects. You will take away a set of project management skills and techniques that can be immediately put to use.
Course Level: Beginner
Course level:TRNG
Global CTD Dossier – Regulatory aspects and focus on quality documentation including concepts of Quality by Design
High quality of a registration dossier facilitates the registration procedure - Essential for Generics! This course provides a comprehensive description on the Common Technical Dossier structure – completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course provides an excellent opportunity to gain an overview of regulatory aspects and includes discussion of the relevant legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the recent ICH-Q guidelines. The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.
Participants will be involved in case studies, group works and have to present the outcome.
Course level:TRNG
Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets
This intermediate course will provide participants practical real-world, actionable information on the nature and development of global regulatory strategies for drug development, with a focus on markets located outside the United States and Europe. Descriptions of the local regulatory environments and requirements for drug developmnet will be enhanced by case examples and by practical experiences in Asia Pacific, Latin America, Africa, and other emerging markets.
Course level:TRNG
Good Clinical Practices for the Clinical Research Professional
Gain the basic knowledge required to conduct clinical trials, including information about subject safety, regulations, and the practicalities of performing research studies.
Course Level: Beginner
Course level:TRNG
High Performance Biopharm Teams
The "SOFT SKILLS" of project management. These are the skills that separate the fast track project leaders from the others. Everyone talks about them. But do we really know how to master them?
Through a variety of interactive and insightful exercises, case studies, and discussions, you will learn to orchestrate a synergistic team environment.
Course Level: Beginner
Course level:TRNG
How to Prepare for a Safety Inspection
Every pharmacovigilance department will, at one time or another, undergo a government or health authority inspection as well as audits by vendors, partners, suppliers, internal auditors, and others. DIA is pleased to present this introductory online course that will teache you how to prepare for an audit/inspection from the time of the receipt of the annoucement (or of the arrival of the inspectors at your doorstep) to conclusion of the audit.
Course Level: Beginner
Course level:TRNG
How to Prepare for Pharmacovigilance Audits and Inspections in Europe
Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.
Course level:TRNG
HTA for Non-HTA User
Given the increasing role of HTA in the pricing and reimbursement decision making across different jurisdictions, there is an increasing need for an introductory course which will provide new users with a sound overview of HTA and its application.
The course consists of theoretical sessions followed by practical workshops. It covers key HTA concepts and provides an overview of methods used in the evaluation of medical technology during pricing and reimbursement decision making process. The practical workshops allow participants to develop skills to interpret HTA findings and build pricing and reimbursement strategy based on HTA outcomes.
Course level:TRNG
Innovative Statistical Approaches for Clinical Trials
This intermediate-advanced online course answers common questions and addresses topics such as modeling, multiplicity adjustments, non-inferiority, data mining, adaptive designs, Bayesian principles, and survival methods. This online course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved.
Course level:TRNG
Introduction to Computer Systems Validation
Gain insight into the basics of computer validation, regulations applicable to computer system validation, how to plan computer system validation for the system's lifecycle, and how to develop an organization's own system instead of purchasing one.
Course Level: Beginner
Course level:TRNG
Introduction to Portfolio Management and Performance Metrics
This highly interactive course will teach participants how to identify and consider the implications of managing performance metrics in their companies. It will provide case studies, simulation exercises, shared experiences, and lessons learned from others who have worked with performance metrics in their organizations. Tools and reference lists will be provided.
Course Level: Beginner
Course level:TRNG
Introduction to Signal Detection and Data Mining
This introductory training course will review approaches to the implementation of signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.
Topics discussed will include signal identification and assessment, application of available regulatory guidance documents, review of data visualization tools to facilitate signal detection and evaluation, and the use of EU GVP Module IX to structure and organize a signal management process.
Course level:TRNG
Medical Affairs Training
Medical Affairs professionals in the health care product development business are now more involved in the product development and lifecycle than ever before. The role and core competency expectations have evolved where many companies are seeking their team to apply their scientific and clinical knowledge to support business decisions related to product life cycle management. DIA's Medical Affairs Curriculum focuses on the essential clinical, regulatory, safety and business principles needed by Medical Affairs professionals. DIA's approach to medical affairs training highlights the importance of interdisciplinary education for health care providers working in the biopharmaceutical arena.
Course Level: Beginner-Intermediate
Course level:TRNG
Medical Approach in Diagnosis and Management of ADRs
This annual training course, considered by many experts as one of the pillars of medical training in pharmacovigilance, focuses on how to use medical knowledge in the diagnosis and management of selected Adverse Drug Reactions (ADRs). ADRs of the main systems/organs will be presented and explained by experts in their medical domain in order to provide practical clues to understand and manage the serious reactions in clinical trials a well as in post authorisation.A medical approach is needed for the identification, labelling and understanding of ADR mechanisms. It can also help assess the probability that a medicinal product may have played a role in the occurrence of an adverse event. This is particularly useful for the first 2 or 3 cases of serious reactions occurring during clinical trials when important decisions must be taken regarding a new drug under development.
Course level:TRNG
Medical Devices: Regulation and lifecycle management
This course will give clear and practical guidelines on how to navigate the development of a medical device in the regulatory landscape, and how to identify the correct development path. It focuses on Europe, but also addresses global standards.
Overview of the EU device legislative system and the principles and philosophy behind it will be discussed. Instructors will also explain the essential features of EU medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.
For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be described in detail.
Furthermore, the process of drafting a design dossier will be highlighted, both for medical devices and for combination products.
Course level:TRNG
New Drug Product Development and Life Cycle Management
Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.
At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.
Course Level: Beginner
Course level:TRNG
Non-Clinical Safety Sciences and Their Regulatory Aspects
This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Course level:TRNG
Oversight of Clinical Monitoring: Trends and Strategies
DIA is pleased to present a three-part online training series focusing on clinical monitor oversight. Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor's performance. This course also focuses on the elements of risk-based monitoring.
Course Level: Intermediate
Course level:TRNG
Overview of Drug Development
This course will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development. During the course, we will discuss some of the challenges to conducting scientifically sound and ethical clinical trials and the continuing evolution of regulatory requirements.
Course Level: Beginner
Course level:TRNG
Overview of Drug Development in Japan
Learn proven strategies for minimizing pharmaceutical development regulatory challenges in the United States and Japan.
Course Level: Beginner
Course level:TRNG
Paediatric Investigation Plans (PIP)
This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry.
Topics will be presented through interactive lectures and hands-on workshop training. Overview of the Paediatric Investigation Plan (PIP) procedure and lifecycle, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs will be discussed. Case-studies and instructor-led group work on specific cases will be presented.
Course level:TRNG
Postmarketing Drug Safety and Pharmacovigilance
Learn about the fundamentals of clinical drug safety and the key tools available for postmarketing pharmacovigilance. Discuss the application and inter-relationships of these tools, and consider future directions for the field. Gain knowledge of the latest changes in the US and EU regulations and best practices for compliance. Develop an in-depth understanding of the requirements and procedures that must be performed to protect patient safety and to remain in compliance with legal obligations in two key regulatory jurisdictions. Didactic presentations will be supplemented with case studies and practical exercises to reinforce learning. There will be ample time for Q&A with the faculty.
Course Level: Intermediate
Course level:TRNG
Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post-marketing studies, and in the healthcare setting following product launch.
Regional developments in the GCC countries will also be highlighted.
Course level:TRNG
Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post-marketing studies, and in the healthcare setting following product launch.
Regional developments in the GCC countries will also be highlighted.
Course level:TRNG
Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
This comprehensive three day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with focus on the US and EU. Topics will span the life cycle of traditional innovative medicinal products, from first-in-human through the postmarketing phase. However, faculty will be prepared to discuss drug safety topics of interest to participants. The course will be delivered in a series of sessions at a basic to intermediate level; didactic presentations will be supplemented with real-world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.
Course level:TRNG
Pre-Marketing Clinical Safety
DIA is presenting an intensive course for professionals involved in management of safety information of clinical trials in the EU. Participants will be guided through all the regulations and guidelines pertinent to pre-marketing safety in the EU.
The course offers an overview of all the current major methodological approaches and hands-on solutions for day-to-day challenges.
Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-Risk Management Plan (EU-RMP) and Risk Evaluation and Mitigation Strategies (REMS) to be ready for a marketing authorisation application.
Course level:TRNG
Premarketing Clinical Safety and Pharmacovigilance
Learn how to comply with evolving US and European (EU) regulations for clinical safety during premarketing development of traditional medicinal products. This basic two-day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety for interventional clinical trials in key regulatory jurisdictions, with focus on the US and EU. Topics will cover approaches to drug safety from first-in-human through the peri-approval phase of innovative product development and will include FDA expectations on IND reporting (single cases and new aggregate assessments), as well as new EU legislation coming into force at end-2016. The course will be delivered in a series of modules; didactic presentations will be supplemented with real world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.
Course Level: Beginner
Course level:TRNG
Preparing for a US FDA Advisory Committee Meeting
What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This course teaches best practices for preparing for an FDA Advisory Committee Meeting.
Course Level: Beginner
Course level:TRNG
Project Information, Communication, and Knowledge Management
Manage the flow of information between team members and stakeholders.
Course Level: Beginner
Course level:TRNG
Project Risk Management
Participants will use a Risk Tracker tool to apply the techniques discussed during the lectures in order to stimulate more in-depth understanding of the risk management process.
Course Level: Intermediate
Course level:TRNG
Proven Strategies for Creating an Effective Clinical Research Program
With the pharmaceutical development process becoming increasingly competitive, complex, and global, it is necessary for clinical research professionals to clearly understand their roles and the roles of others they interact with. This knowledge helps them facilitate a pharmaceutical development process that is both timely and completed within budget.
Through interactive lectures and exercises, this online course will provide clinical research professionals with the knowledge and skill set needed to improve the pharmaceutical development process. Topics to be addressed include product development strategy, clinical trial management and development, project management, and quality concepts.
Course Level: Beginner
Course level:TRNG
Quality by Design - Quality by Design - New concepts for Chemical and Biotech Product Development and Optimisation
Quality by Design (QbD) concepts are becoming the defacto best practice spearheaded by the FDA and EMA. But how can you implement ICH Q8-Q11 with confidence for small molecules and biotech products?
As part of our Chemical Manufacturing series, DIA brings together expert faculty from Regulatory agencies, academia and industry. ICH and DoE expertise will accompany you to building a practical knowledge base.
By the end of this 2.5-day course, you will have enough knowledge and reference points to establish a Design Space and essential elements of the Control Strategy. Through a series of case studies you will learn how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).
Case scenarios include:
- solid dosage form of a small molecule
- manufacturing process for a biotech product
You will learn how to prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate non-critical parameters.
Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will investigate how a systematic approach to pharmaceutical development and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings and regulatory flexibility will be discussed with a key European regulator.
The course will also provide an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.
Course level:TRNG
Regulatory Affairs for Biologics
Participants in this training course will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and cellular therapy, and the different ways that CBER and CDER view product development. The course will also discuss proven strategies to achieve regulatory success in the development of biologics.
Course Level: Intermediate
Course level:TRNG
Regulatory Affairs: The IND, NDA, and Postmarketing
Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements
Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of real-world and interactive lectures, workshops and online precourse modules. This basic to intermediate level training course focuses on prescription drugs and well characterized biological products. The requirements specific to generic drugs, biosimilars, devices, and OTC monograph products are not covered in detail.
Course level:TRNG
Risk Management and Safety Communication Strategies
Risk Management Best Practices to Optimize Medicinal Product Safety
Risk Communication is increasingly important to everyone involved in the health care system, especially the patients whose lives we strive to improve. This intermediate class will look at current initiatives and new strategies to advance the safe use of drugs through better communications in an attempt to maximize patient benefits while minimizing the risks of medicine use.
Course Level: Intermediate
Course level:TRNG
Signal Management in Pharmacovigilance
The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook.
The entire course is updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII. Time has been set aside for exercises, questions and discussions.
Participants will be provided with preparatory material in order to better participate at the group exercises onsite.
Course level:TRNG
Strategies for Good Clinical Practice Audits
Learn basic knowledge of Good Clinical Practice audit programs and strategies. This online course is designed to help you with types of audits and inspections, audit reporting, general procedures in preparing for a FDA inspection, role and findings of FDA inspections and how to successfully handle and respond to a FDA inspection.
Course Level: Beginner
Course level:TRNG
The Basics of Clinical Data Management From Start to End
This one day face-to-face course will introduce participants to the basic principles of clinical data management. Relevant information and instruction will be covered on data management to include, data capture instrument design, data editing, data tracking, metrics, and much more. This interactive course will allow participants the opportunity to run through a series of hands on exercises.
Course Level: Beginner
Course level:TRNG
The development of biopharmaceuticals - The big picture, innovation and scientific requirements
The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted for the practical application of knowledge gained. The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments in this fast moving field. This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products. Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.
The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted for the practical application of knowledge gained.
The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments in this fast moving field.
This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products.
Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.
Course level:TRNG
The Impact of Regulatory Affairs on Chemistry, Manufacturing & Controls (CMC)
Generics are becoming increasingly central in both industrialised countries and in developing countries. The overall requirements for generics will be detailed including problems in relation to generic substitution and falsified medicines.
The course will consider the important aspects for Active Pharmaceutical Ingredients (APIs), such as requirements to the production and supplier qualification and certification. The implementation of ICH Q11 will be discussed.
Bioequivalence testing is an integral part of the development both of new medicinal products and of generics. Revised EU guidance has been developed and the impact of the new guidance will be thoroughly discussed.
Globalisation is an important element in the production of drug substances and drug products to be licensed and marketed in Europe. This course will focus on three essential topics which are particularly influenced by production in a global environment.
The course will be taught with a combination of presentations by the faculty and work in small groups assisted by faculty members. A significant amount of time will be devoted to working on case studies. Results from the working groups will be presented to the full audience.
API production/API supplier qualification and certification
ICH Q11/EDQM CEP/WHO pre-qualification
- Selecting and justification for a starting material
- Supply chain traceability
- Responsibility of the API manufacturer
- Responsibility of the pharmaceutical company
- Impurities
- Quality by Design (QbD)
- Critical Quality Attributes (CQA's)
- API inspection/supplier audits
- Lifecycle management/variations
- Value and role of certification (EU/WHO)
Bioequivalence testing
- Basic principles
- Design of studies
- Pharmacokinetic parameters
- Analytical considerations
- Acceptance criteria
- Biopharmaceutical Classification System (BCS)
- Biowaivers – how to avoid the need for in-vivo studies
Generic medicines
- API requirements; known versus new substances
- Pharmaceutical development
- Bioavailability/bioequivalence
- QbD
Course level:TRNG
The Leadership Experience
LeaderPoint, in cooperation with DIA, conducts this comprehensive, three day management and leadership development program. This easy-to-understand course will provide learners with real-world training on applying interpersonal and leadership concepts to meet and exceed business goals.
Course Level: Intermediate/Advanced
Course level:TRNG
Training Course for eCTD Submissions in Switzerland
Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.
Course level:TRNG
US Regulatory Affairs
As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information? This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes. This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeking marketing approval for a product (NDA & BLA) and post-marketing regulatory requirements in the US.


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The Sail Loft, on the Water in the Center of Historic Castine, Private Dock(4 Reviews)
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- Minimum stay:1-6 nights
- Sleeps:5
- Bedrooms:3
- Bathrooms:3
- Property type:House
- Internet:Yes
- Pets considered:No
- Wheel chair accessible:N/A
About the Property
House, 3 Bedrooms, 3 Baths, (Sleeps 5 comfortably)
Sail or drive into Castine's harbor, right up to the private dock or parking space and walk right in. This one-of-a-kind home has two stories. The upper level is the main open living and dining space, with a cantilevered deck over the water. The lower level is the more relaxed living and sleeping space, with a glass floor to see the tide (and sea life) come and go. Outside is a private courtyard, surrounded by stacks of lobster traps with easy access to the dock or down to water's edge, to spy on the starfish.
Castine, a small coastal village of approximately 7.9 square miles, is located on a peninsula in the East Penobscot Bay Region of Maine. The town, on the National Register of Historic Places, consists of two distinct geographic areas referred to as the Village and 'off neck,' a narrow strip of land that separates the Bagaduce River on one side from the Penobscot Bay on the other.
More than 100 historic markers can be found in this town characterized by its 18th century architecture. Major landmarks include Fort George, built by the British in 1779 and partially restored as a state memorial, and Fort Madison, earthwork remnants built by the Americans in 1811, occupied by the British during the War of 1812 and reconstructed during the American Civil War.
The year-round population is roughly 1,300 including 800 college students attending Maine Maritime Academy. With summer residents, and visitors by land and sea, the population at least doubles from Memorial Day to Labor Day.
Castine is located in the East Penobscot Bay Region of Maine, 1 hour from Bangor, and 1.5 hours from Camden and from Bar Harbor. Situated on a peninsula, Castine is bordered by the town of Penobscot to the northeast, Brooksville across the Bagaduce River to the southeast, and near Islesboro to the southwest.
Member since: 2012
Property Type
- House
House Rules
- Max. occupancy 5
- Non Smoking Only
Accommodation Type
- Vacation Rental
- Guests Provide Their Own Meals
Onsite Services
- Housekeeper Optional
Bedrooms: 3 Bedrooms, Sleeps 5, Beds for 5
Bathrooms: 3 Bathrooms
Other Amenities
- Books
- DVD Player
- Games
- Satellite / Cable
- Stereo
- Television
- Adventure
- Away From It All
- Family
- Historic
- Sports & Activities
- Tourist Attractions
- Churches
- Library
- Marina
- Museums
- Playground
- Restaurants
Local Services & Businesses
- ATM/Bank
- Fitness Center
- Groceries
- Massage Therapist
- Medical Services
Leisure Activities
- Antiquing
- Beachcombing
- Bird Watching
- Boating
- Scenic Drives
- Shelling
- Shopping
- Sight Seeing
- Sledding
- Walking
- Wildlife Viewing
Location Type
Ocean View:
The entire castine harbor is all around you..our historic water front restoration is totally over the water at high tide with a large glass floor to see what swims by. Waterside is all glass + deck......moreless
Our 180 year old structure is literally out and over the water with a private pier and float for a medium size boat, with a mooring close by for larger boats. Revived and restored [2006-2009] keeping it's historic soul while adding the comforts of contemporary details, appliances and fixtures. Furnishings are a combination of original, antique, mid-century modern and even an old church pew... for a comfortable and exceptional experience – that cannot be matched. This one-of-a-kind sail loft was part of Castine Historical Society's 2011 House Tou...moreless
All shops, restaurants, bakehouse, boatyard, bike and kayak rental and most activities are a short walk. ...moreless
the waterside of the old sail loft is all glass with deck off the daytime living area for great views and interaction with all the activities on the bay ....moreless
Sports & Adventure Activities
- Cross Country Skiing
- Cycling
- Fishing
- Fly Fishing
- Golf
- Golf Privileges Optional
- Hiking
- Kayaking
- Mountain Biking
- Pier Fishing
- Sailing
- Sound/Bay Fishing
- Surf Fishing
- Swimming
- Tennis
- Dining Area
- Seating for 10 people
- Air Conditioning:
- Clothes Dryer
- Free Long Distance
- Hair Dryer
- Heating
- Internet
- Iron & Board
- Linens Provided
- Living Room
- Mobile Phone:
- Parking
- Parking Off Street
- Catering Available:
- Coffee Maker
- Cooking Utensils
- Dishwasher
- Ice Maker
Complete, Modern Kitchen. Oven, Gauganau cook top units with built in steamer and pot filler, stainless counter top, 2 drawer type dishwashers, an array of counter-top appliances - and ample service settings, utensils, cookware....moreless
- Balcony
Deck / Patio:
2nd level deck over the water - and a ground level side courtyard surrounded by lobster traps for added privacy......moreless
castine golf club....we are not members but tee times can be reserved...moreless
- Outdoor Grill
House Cleaning
- Housekeeper Optional
RatesCurrency Conversion
|Weekend Night
|Monthly *
fall > winter
Sep 12 - May 25, 2017
6 night min stay
May 26 - Sep 11, 2017
6 night min stay
fall > winter
Sep 12 - May 25, 2018
6 night min stay
Additional information about rental rates
longer term stay - - rates negotiable
longer term stay - - rates negotiable
full payment due to secure rental (paypal, check or money order)
50% security deposit or renter protection insurance required
cancel 60+ days to arrival (75% return) no refunds less 30 days, unless re-booked*
check-in time after 3pm, check-out time before 10am
*travel insurance recommended for renters to cover any possible unforeseen expense
Owner's cancellation policy:
Policy available by contacting owner when booking
Don't forget your vacation protection! Get protected now
Adding our Vacation Protection services can make sure your getaway goes smoothly, no matter what. We offer Cancellation Protection and Damage Protection so you can truly relax.
Car: Recommended
Historic small town with a beautiful, active harbor has museums, shops, a variety of restaurants and the Maine Maritime Academy. Summertime brings farmers market, outdoor concerts, sailing regattas, marine wildlife viewing, great kayaking, and much more. The local boatyard for fuel and service, is just down Sea Street, and the town dock and boat ramp are steps from the front door. We are in the center of the towns activities and literally over the water !!
Owner info
Year Purchased: 2003
About the owner: We're a family who has a passion for Maine, and feel very fortunate to have the sail loft and be part of it's future. Preserving a bit of Castine's history and it's harbor front has been a wonderful experience for us. Our hope is to have a few others share this special place.
The Unique Benefits at this House:
From 1882 through the early 1900's the sail loft housed an active sailmaker, sewing sails for commercial vessels from all around the northeast. Now, 13 Sea Street is a unique property that is like no other, hard to compare. It is adjacent to the town dock and boat ramp, has it's own private dock, easy walking distance to Eaton's boatyard, restaurants, shops, bike and full kayak services ... you are in the middle of this small, friendly community. Our property manager will meet you upon arrival, explain the sail loft and Castine.
Contact us
Send email
Links to more information:
exterior Sail Loft from the town wharf
exterior from sea street side
side yard from the sea street side
living area upstairs - looking out to water and deck
living area upstairs ... several books on traveling in maine
dining table - upstairs ... candle or recessed lighting
bar - downstairs living space. clear story glass allows light to travel into the space.
second bedroom - downstairs. clear story glass allows light to travel into the space.
master bath - downstairs - large walk-in shower to left of picture
the sail loft at dusk from waterside
private dock with access to a mooring
side yard from waterside (stairs to water)
looking towards kitchen upstairs - from water side
kitchen upstairs - looking towards water
glass bottom living space - downstairs
master bed - open to living space - downstairs
third bedroom - downstairs - twin only
est floor plan of lower level
This listing was first published here in 2012.
Date last modified - Friday, April 21, 2017
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This thesis explores the creative relationship between an actor and a director on a low budget film set and theorises about the nature of their personal interactions over a number of film shoots and rehearsals. It pays particular focus to their interpersonal conflicts, behaviour, and the extent to which their interactions shift or develop over time. Given the limited ethnographic focus on film sets within the literature, this research builds a set of theory which aims to understand low budget film sets, the creative processes which shape them, and the behaviour of agents who interact within them. This research may be useful for filmmakers, actors, or those interested in theory relating to the framing of social experiences and human behaviour.


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Andy Brickley on D&C: 'I don't like the way [Canucks] play the game'
|06.13.11 at 9:42 am ET
NESN Bruins analyst Andy Brickley called in to the Dennis & Callahan show Monday morning to talk about the Stanley Cup finals and Game 6. To hear the interview, go to the Dennis & Callahan audio on demand page.
Brickley said that despite Vancouver's home-ice domination during the Stanley Cup finals, the Canucks certainly aren't going to sit back Monday night and wait to play Game 7 back home.
'They want to end this thing tonight, because anything can happen in Game 7,' Brickley said. 'And you don't know how you are going to come out of Game 6 in terms of your health.'
The Bruins, meanwhile, must counter with the determination to prevent the Canucks from celebrating on their ice.
'Not in our building, not in our house, not at the Garden,' Brickley said. 'They do not win a Stanley Cup on here on our ice in front of our fans.'
Brickley said that Roberto Luongo's trash-talking Tim Thomas was a case of 'a guy that's a little bit immature when it comes to dealing with the media.'
'I think there's a hint of jealousy in what he's saying about Tim Thomas,' Brickley said.
Barry Pederson on D&C: Bruins 'let Vancouver off the hook'
|06.13.11 at 9:34 am ET
NESN Bruins analyst Barry Pederson joined the Dennis & Callahan show Monday morning to discuss the Stanley Cup finals. To hear the interview, go to the Dennis & Callahan audio on demand page.
Pederson said he was surprised at the Bruins' inability to match the Canucks' intensity in Game 5 Friday night.
"Momentum has been funny this series," Pederson said. "The Bruins had momentum going out to Vancouver and I thought let Vancouver off the hook. They didn't make [Roberto] Luongo's life very difficult. They had four power plays, and all they needed was just even one to get some momentum. Vancouver, to me, was the far more desperate hockey club, outhitting and taking the play to the Bruins."
Asked about Luongo's comments regarding Tim Thomas, Pederson said Luongo may have been affected by all the pressure he faced going back to Vancouver and felt a little smug after posting a shutout following two routs in Boston.
"Tim Thomas has played spectacular this entire series, every game," Pederson said. "Win, lose or draw, I think Tim Thomas is going to be your Conn Smythe winner anyway. To me, it was more of [Luongo] was just relieved they had won the game."
Pederson talked about the Bruins' matchups ' specifically how they try to get defensemen Zdeno Chara and Dennis Seidenberg on the ice against the Canucks' first line ' and how it's affected the attack.
"I think they work so hard at trying to get that, I think sometimes it takes away from your offense," Pederson said. "If they're able to win tonight, which I expect, then I would think maybe they may try to change things up a little bit [for Game 7] and maybe split Chara and Seidenberg so that one of two of those are on the ice every time."
Pederson picked Milan Lucic as the key to the Bruins' offensive success.
"I think that's going to be the key for the Bruins, is attacking, five-man attack, get the forechecking game going and get the Garden crowd into this thing early on," he said. "We said it all season long, obviously Thomas is the key in goal, but to me, the key person up front is Milan Lucic. He's the key that sets the pace for this hockey club. He's the guy that gets that puck dumped softly into the corner, making the defenseman turn around, and that's defenseman knows ' he can hear him coming ' he knows it's going to be a big hit. And as soon as that big hit happens, the Garden crowd goes crazy, momentum happens and the Bruins can get a team on the run."
Force on D&C: Canucks fans 'in for a hostile situation'
|06.13.11 at 7:52 am ET
The man who goes by the name of Force, half of the Green Men duo, joined the Dennis & Callahan show Monday morning as he prepared to head to the airport in Vancouver for his flight to Boston for Game 6 of the Stanley Cup finals.
Force, who dresses up in a green spandex bodysuit to cheer on his team and taunt the opposition, said 90 percent of Bostonians treated the Green Men well during their previous visit (watch the video here), but the other 10 percent "made up for it" by antagonizing him and his partner, Sully. He expects a similar reaction Monday night.
Said Force: "I think win or lose, Bruins fans are going to intensify their hatred toward us. I fully expect it. '¦ They definitely made it known we are not welcome for Games 3 and 4, so I can only imagine it's going to be worse tonight."
Force and Sully are on a direct flight to Boston with about 50 other fans. Cautioned Force of his fellow Canucks backers: "I hope they are well aware that if they weren't there for 3 and 4, they're in for a hostile situation."
Asked for a prediction on Game 6, Force did not voice any confidence.
"The Canucks are so hit-and-miss on the road and the Bruins have been so dominant in TD Garden," he said. "To be honest, I think the Canucks will have a hard time winning tonight. '¦ I'm hoping the Canucks pull it out, but it's going to be tough."
To hear the interview, go to the Dennis & Callahan audio on demand page. For more Bruins news, visit the team page at weei.com/bruins.
Bruins-Canucks Game 6 preview: 6 keys, stats and players
|06.13.11 at 4:03 am ET
The Bruins are playing in either their last game or second to last game Monday. Either way, it will be the finale at the Garden as the B's look to fend off elimination and force a Game 7 of the Stanley Cup finals, which would be played back in British Columbia. Here's the preview of Monday's contest.
– Make it about quality, not quantity: Canucks goalie Roberto Luongo has faced 30 or more shots in each of his shutouts in the finals, and both of those blankings have been cakewalks. The Bruins need to establish a physical presence, create traffic and get in front to beat the Vezina finalist.
– Don't let the Cup make an appearance: Everyone knows the Stanley Cup will be in the house Monday night, but the Bruins' worst nightmare has to be watching Alexandre Burrows, Luongo and the rest of the perceived bad guys skate around with it on their ice.
– Remember their Game 6 experience: It's as cliche as it gets to say that the last win is the hardest in a series, but the Bruins should know. Both the Canadiens and Lightning didn't let the Bruins storm into their home and eliminate them, so the B's will need the same desperation that beat them in those games.
– Remind everyone of Games 3 and 4: The Bruins were able to make things very difficult for the Vancouver defense and Luongo in the two games here, but Vancouver tightened back up defensively back at Rogers Arena, while the B's stiffened up offensively.
– Give Tyler Seguin time on the power play: It's the one place he won't be afraid of getting hit and can focus just on using his talent. The B's went 0-for-4 on the man advantage Friday in Vancouver, with Seguin getting only 12 seconds on the power play.
– Use Zdeno Chara in front on the power play: It may not have yielded results the last time around, but it's worth using from time to time. If the Bruins can't even get set up as it is, can it get much worse?
– The Bruins have won nine of their last 10 home games dating back to Game 5 of the quarterfinals.
– Dennis Seidenberg's only goal this postseason came in Game 6 of the quarterfinals, and it was Boston's only goal in the 2-1 Canadiens win.
– Though David Krejci leads the NHL with 22 postseason points, he's only registered points in a loss twice. His hat trick in Game 6 of the conference finals made for three of the four points in games the Bruins have dropped this postseason.
– Despite missing two games due to a concussion, Patrice Bergeron leads all Bruins with 62 shots on goal this postseason.
– Henrik Sedin has gone five straight games without a point for the first time since the 2007 postseason. He had two such stretches in 12 games in those playoffs. The last time he went six games without a point was from Nov. 29-Dec. 20, 2003.
– Daniel Sedin has gone three straight games without a point three times this season, including once in the playoffs. He has not going four games without a point since Feb. 4-11 of the 2009-10 season.
Milan Lucic: After not showing up in Game 5, Lucic has to have the best game of his life Monday. If something is ailing him, then it's commendable that he's played through it, but the B's need their best players to be the best players on the ice. Not having Nathan Horton is bad enough, and the B's not be able to survive with another zero-shot performance like Friday's.
Brad Marchand: The rookie needs to be the royal pain he's been all season, and he also needs to come out flying the way he did when he dominated Game 4. It had seemed he was on a roll with goals in two straight games, but apparently Rogers Arena is where any positive Bruins trend goes to die. Marchand has three shots on goal over his last three games, though two have gone in.
Tim Thomas: It's hard to ask any more of Thomas, who it seems will be getting the Conn Smythe Trophy. He's allowed six goals in the finals and could conceivably lose the series having allowed just seven goals in seven games.
Alexandre Burrows: The refs shouldn't look at any plays involving this guy based on his diving. It seems the refs looked the other way with Burrows got cross-checked by the net.
Raffi Torres: The third-liner has three shots on goal this series, but one of them went in to seal Game 1 for the Canucks. He has two assists in the last three games.
Roberto Luongo: The mechanic himself did not have success the last time he was at the Garden, and he might need to show up big after letting up 12 goals in Games 3 and 4. If Luongo were to clinch the Cup for the Canucks with a shutout Monday, that would be quite remarkable given that it would be his third this postseason.
Aaron Rome speaks (to some), 'definitely' disagrees with suspension
|06.12.11 at 9:51 pm ET
The Boston media didn't hear it, but Aaron Rome spoke Sunday at TD Garden, meeting with the media for the first time since being suspended four games for the hit that ended Nathan Horton's season.
As Vancouver press conferences wrapped up and writers took to their computers, Rome made his way to the Canucks' locker room, where plenty of non-Bruins media were waiting to talk to the defenseman. For one reason or another, Boston writers weren't made aware of it, but oh well.
Rome told reporters that he disagrees with the league's decision to slap him with a four-game suspension and end his chance at playing for a Stanley Cup.
'It's tough,' Rome said. 'You start the finals and you're excited about having the chance of a lifetime. It's just an unfortunate incident where it's just an unfortunate decision where it's a split-second decision. However you view the hit, whether you think it was dirty or not, there's no intent to hurt anybody.
"I've been on the tough end of hits like that. If I could go back I'd wish he didn't get hurt but I don't think that it would change my decision on the play."
Added Rome: 'It's emotional. You can't put it into words. You work hard all season and all playoffs and for a guy like myself who's in and out of the lineup, getting a chance to play every day and working your bag off to be out there. It's disappointing.'
Rome reached out to Horton, who he said has yet to text him back.
'It's an emotional time and he's not going to be able to play in the series, too," Rome said. "I understand, being on that side of hits, where you're pissed off about it. He wants to be out there, like anybody.'
The defenseman expressed frustration with the fact that the league didn't take his clean track record into consideration when making its decision, and while the league was generous with not saying it had anything to do with Rule 48, Rome felt it wasn't dirty in any way.
'That's the type of hit where a guy is vulnerable,' said Rome. 'I saw him coming but there's nothing you can do. My hit, they say, was late. It's arbitrary. What is late? That's a decision they made and I'll have to respect it, but I definitely don't agree with it.
'If it's a half second earlier or a quarter second earlier maybe I'm not in this situation. But the game happens fast. I've got to play on the edge and I guess that time it was a little bit over the edge.'
By the looks of what Rome said, it sounds more like he's making himself out to be a victim, while it sounds like the fluff questions he faced came with whatever kind of ice cream he wanted. Maybe that's reading too far into it, but it's hard to tell when you aren't there.
Canucks trying not to get too excited about being one win away
|06.12.11 at 4:48 pm ET
The Canucks are trying to stay as level-headed as possible leading up to Monday's Game 6, but they know it's going to be difficult given the fact that they're one win away from hoisting the Stanley Cup.
"I think it's natural to be excited," captain Henrik Sedin said. "We're in a great spot. We're one win away from winning it, so we're excited. But we know if we get out of our comfort zone and start getting overly excited, it's going to take away from our game. That's a key for us, to come in here tomorrow and play the way we have all year."
Forward Christopher Higgins said it will be crucial for the Canucks to strike a balance between thinking about the Cup while also focusing on the game at hand.
"I think you have to think about it," Higgins said when asked about the possibility of lifting the Cup. "That's what you're playing the game for. But there's a lot of hard work, and you still have to play the game. You still have to do the right, little things out there."
Three of the Canucks' top players — the Sedin twins and goalie Roberto Luongo — have won an Olympic gold medal (the Sedins in 2006 with Sweden and Luongo in 2010 with Canada), but they all said winning the Cup would be even bigger.
"Both Louie and us played in the Olympic finals and that's obviously a big game, too, but as a hockey player, this is what you want to win," Daniel Sedin said. "It's the toughest thing you can win. You work so hard with your friends and teammates to get to this point. We're going to enjoy it. Hopefully we can put a better game on the ice tomorrow and we'll be fine."
"They're both unbelievable, but very different," Luongo added. "The Olympics is a very short tournament. This is a two-month grind, probably one of the hardest things we've ever had to do. In the end, if you come out on top, it's the most rewarding thing that you can probably do as an athlete."
Roberto Luongo doesn't want to talk about Tim Thomas anymore
|06.12.11 at 2:57 pm ET
Roberto Luongo has certainly created quite the buzz these last few days. After the Canucks' 1-0 win in Game 5, he took a jab at Tim Thomas by saying Maxim Lapierre's game-winning goal would've been an easy save for him because he would've been in his crease. Then on Saturday, Luongo complained that Thomas hasn't said anything nice about him while he's been pumping Thomas' tires all series.
Maybe Luongo got bored with all the back-and-forth, or perhaps someone told him it was best not to say anything else, because on Sunday Luongo said he was done talking about his comments on Thomas.
"I know we're in the Stanley Cup Final and everything is under the microscope and going to get blown out of proportion," Luongo said when asked if he regretted making those comments. "My whole comment, I don't think was a negative comment.
"But at the end of the day, I'm one win away from winning the Stanley Cup, and that's all I really care about right now. All that other stuff is noise to me and doesn't really affect what's going to take place for me tomorrow night. To be honest with you, I don't really care."
Canucks forward Christopher Higgins agreed with Luongo that the media has made too much of everyone's comments.
"Certain little things are blown way, way out of proportion and way over-analyzed," Higgins said. "I think that's been the case for a lot of things that have gone on this series."


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I don't own any of the Harry Potter characters
It seemed absurd that he should have forgotten protection; he usually carried contraceptive patches around in his back pocket, just in case... but on this one occasion when he actually needed it, he had forgotten, and the feeling of utter uselessness in his stomach quadrupled.
"I..." he frowned to himself. Obviously, he could do the charm, but most witches refused to have sex if they hadn't had the charm and the patch applied; the charm could be incorrectly performed afterall when done on it's own, and he knew more people than he cared to mention who had accidentally quoted the wrong incantation and given women an appendage that rather forcibly meant they were no longer in a state of arousal.
"You silly boy!" Lola said, pulling back and looking scandalised. "Did you really think you could come here and have your way with me and not bring protection?" She tutted, shaking her head and waggling her finger, then smirking devilishly as she sat herself on the sink. "Naughty naughty Jamesy..."
"I can go and get some..?" James suggested weakly, rubbing the back of his head ashamedly.
Lola shook her head. "I'll have lost 'the mood' by then..." she chewed her lip, then leapt forward, grinning, wrapping her arms around his neck. "Put your hand on my ass."
"Excuse me?" James spluttered, blinking rapidly.
"I've got a little something for you... but you'll have to work for it..." there was a cheeky glint in her eye that was not to be ignored, and so he moved forwards and gingerly placed his hand on her buttock, frowning nervously.
"You... you mean like this?"
She nodded, smirking. "But stroke it a little more..." she giggled wickedly, pushing her face into his neck and sucking and biting as he gingerly caressed her through her jeans. As she kissed him, his pressure became slightly more pronounced, and she was suddenly pulling away from him and grinning, readjusting her trousers as she looked at him. "Bad, bad boy!"
He gulped, feeling incredibly frustrated as she trailed her hand upwards, toward her breasts, and up between them, before suddenly disappearing down her blouse. "Fuckk!" He hissed, averting his eyes in an effort to control himself. "Merlin, Lola, that was just... really stop..."
"Ok." She said plainly.
He looked around and saw her waving a bright red packet at him. He could have kissed her, but for the huge bulge in his trousers which might well have gotten in the way. "I thought..."
"I was testing you..." she looked at the packet critically, then held it out towards him. "Want to put it on for me?"
James grinned, stepping forwards and snatching it from her fingers. "Where'd you like it?"
She smirked. "I like it anywhere."
Chuckling, James suddenly found himself in familiar territory, and didn't need the flirting and awkwardness. It was suddenly extremely easy to believe he was good at flirting, to have found himself in this position so easily. "I bet you do," he said in a low voice which was gravelly and lustful, just as he undid her top and lifted it over her head, his spare hand sliding down to her fly and unfastening it. "You a tits or ass girl?"
"I'm a dick girl." She said with a smirk. "You?"
"Niether." He said softly. "I'm a thigh man." His hand trailed teasingly over his upper thigh, just before he slid the trousers down her legs.
"Thighs?" She said, surprised.
He nodded. "Mmmhmm."
He grinned. "Tits and ass are fine. But does it really feel as good when I'm sucking your nipples as it does when I'm licking your thighs and refusing to touch you?" His eyes glinted. "And besides," he went on, "its about tone..." he squeezed her thigh softly, appreciatively. "Theres no such thing as toned tits! And toned ass is bullshit." He leant next to her ear and smiled. "Nothing to hold onto when I'm going all out!"
She clung to him rather viciously, unable to move, while he lifted the packet to his mouth and ripped it easily open with his teeth, just before bringing the sticky patch down onto her rear, watching the slight ripply of skin that peaked out from the scarce thong she wore. It flashed green, then disappeared, and he smirked. "Perfect."
She moaned quietly, then pressed her lips to his fiercely. He might have decided to tease her, had he not suddenly realised that he too was suffering from intense arousal which he'd somehow managed to keep at bay with his obscenely dirty talk that he would never have believed himself capable of.
"You ever done it in a bathroom before Lola?" He murmured against her mouth.
She smiled. "I did once..."
James smirked. "Did you like it?"
With a shrug, she started unbuttoning his shirt. "It wasn't particularly enthralling... but then, I was drunk." She grinned. "Hard to remember much that happened that night really."
"Trust me," he murmured, "if I ever shag you when you're drunk, you'll remember it."
"Oh yeah?"
"Mmmhmm..." he kissed his way gently down from her ear to the base of her neck, then smiled, slipping an arm round her back and unfastening her bra before throwing it to the side. "I'm unforgettable."
"Really?" She asked, grinning. "Maybe you'll have to prove that to me..." her hands slid his shirt from his shoulders, then trailed down his body, unfastening his jeans with difficulty and pushing them down on his hips, grinning at the bulge in his boxers that stood to attention, and which she avoided with deliberance as she pressed gentle kisses to the centre of his chest.
"Just tell me when," he grinned, lifting a hand to the back of her head and stroking her hair gently.
Lola smiled, sliding slowly down his body and placing kisses all the way down his toned abdomen. "Don't I still owe you from the other day?"
James chuckled. "I was going to ask for that favour later!"
She placed a teasing kiss to the skin bared just above his boxers, then wiggled her eyebrows at him provocatively. "Black boxers? How original!"
He smiled. "I save originality for when I'm out of the clothes." His hand slid over her bare shoulders teasingly, just as she began to slide his boxers down. He waited patiently for her, then smiled as she let out a low whistle of appreciation.
"Now, where have you been hiding this Mr. Black? I'm not quite sure how it's remained inside those boxers of yours!"
Laughing, he looked down at her, smiling in amusement. "I'm surprised you're even here still... or did you not realize I'm wearing boxers against your orders?"
She looked at him assessingly, then shrugged. "I suppose... well.. it's not too bad...I mean... I can bear it anyway..."
James raised an eyebrow. "You know, I think you've gone soft on me..."
"Well," she said softly, "at least its me and not you..." she looked up and down his length appreciatively, then smirked. "Do you mind if I...?" She motioned towards him with a glint in her eyes.
"Feel free..." he murmured, voice slightly croaky as his throat dried at the thought of it.
She leant forward and pressed her lips to his head, and a groan escaped his lips. "Merlin..."
"Lola!" She corrected him, before opening her mouth and taking his swollen tip in her mouth.
He smiled, pushing slightly deeper and winding his hand in her hair. "Shh," he whispered. "I'm enjoying myself."
An overwhelming rush of excitement overcame him as she sucked him into her mouth deeply, swirling her tongue lightly over him before moving to lick a slow line along the length of him. At the same time, her hands cupped his testicles, gently squeezing and caressing him, before taking him back in her mouth and letting out a low moan of delight. He hissed, pulling out of her mouth and lifted her roughly to her feet, pressing her against the wall before pushing into her quickly.
Deep, warm and wet, he buried himself within her folds, so that there was nothing in the whole of the world at that moment that could have torn his mind away. She moaned into his neck as she bit and suckled at his skin, leaving bruises and marks that would clearly show the next morning. He didn't care. He slid in an out with speed, gasping and sighing with each renewed thrust into her heat.
"Yes," she murmured, as her back grazed up and down the wall with the speed of his thrusts. "Oh god, yes."
James caught her lips between his, sucking them briefly before plunging his tongue deep into her mouth. "I've dreamt of this.." he muttered. "God, I've dreamt of this.."
"Tell me..." she said with command. He smiled, his head falling to her shoulder as he continued on, feeling her muscles clench around him slightly.
"Fucking you... having you around me, like this... feeling you, wet and tight and hot..." He groaned as he felt her clench even tighter, felt her whole body stiffen.
"Please..." she whispered. "I need to come... shit James, I need to..." he silenced her with a fierce kiss, hand sliding down between them and rubbing against her clit with ferocity. She whimpered against him, buckling in his arms as her white hot orgasm poured over her. He hissed, closing his eyes as he felt his own release torn from him, stars bursting before his eyes as he buried his face in her neck, a groan marking his completion.
He was half asleep the next morning as he came down to breakfast, his eyes heavy and stuck together with sleep. He slumped down on the table beside Ricardo, who grinned knowingly and said nothing, before loading his plate with food.
"Hungry?" James said sleepily, just as he himself scooped four sausages, three rashers of bacon, beans and mushrooms onto his plate.
Ricardo nodded, then smirked. "You too?"
James flushed red. "A... maybe a little..."
"Good night?"
James didn't answer. That was enough for Ricardo. He howled with laughter and slapped James on the back, grinning stupidly and shaking his head in amusement. "You old dog!"
Tucking into his food, James kept quiet, but was distracted when an owl swooped down and dropped a piece of parchment in his lap. He frowned and picked it up.
Open this at the table.
Dare you!
With a useless attempt at covering up his grin, he unfolded the paper hastily, scanning the paper quickly before choking on his food.
"You ok mate?" Ricardo asked. James nodded, embarassed, but could not resist the urge to read the whole of the letter.
Big boy,
I'm so randy for you right now.
Can't stop thinking about you fucking me. You look so hot when you're coming. I want to be under you right now, with you riding me hard, sucking on my nipples and telling me how tight I am.
I'm so wet for you.
Do you have any idea how good it felt to be sucking you off? I wish you were in my mouth right now, grabbing my hair and shoving me down on you however you want it. Want to taste you so badly, tell you how good you taste, how much I want you to just let go and give me everything.
Are you hard yet? Wish I was there with you, making it go away... but I'm in my own little bed, feeling all lonely and turned on without you...
Fancy a shag?
Ricardo snorted, and it was only then that James realised his friend had been reading over his shoulder.
"Jeez mate, you sure know how to pick them don't you? I'm telling you, you better write back or she'll be onto someone else!"
James rubbed his neck nervously, attempting to hide his embarassment, which was slowly mingling with pride, from showing on his face.
"I'll be back in a bit," he said suddenly, jumping up and almost running into Lily. "Shit!" He swore. "Sorry Lilz! I'll talk to you later!"
He didn't look back, but ran for the owlery quickly, sprinting up the marble staircase two steps at a time.
He stepped on the soft straw-covered floor, strewn with droppings and broken quills, and whistled down his own owl. He looked at the eagle owl nervously, then spoke quietly to him. "Alright mate, I know we don't usually do this kind of thing but... well... I need to write this one so... well, wish me luck Ok?"
He pulled his own quill from his bag and chewed it thoughtfully before withdrawing ink and parchment and beginning to write.
can't make the shag right now, but enjoy your time alone in bed... just think about me and you'll feel better...
He shook his head and scratched the sentence out, balling the parchment up and discarding it.
Hope you're having fun in bed. Want to be with you but have Potions...
He sighed. "Fuck it. Just write. She won't care!"
With a reassuring smile to himself in the glass window, he began again.
Lola smirked as the eagle owl tapped on the bedroom window, and she instantly danced across to open it, taking the folded parchment in her hand and grinning wickedly.
You bet your ass I'm hard.
Do I fancy a shag? When don't I?
Hope you've had your daily dose of caffeine; you're going to have a very long night ahead of you!
You realize you deserve a serious spanking after all that dirty talk at breakfast? Hope you like it kinky, because right now you should really be tied down to my bed with some VERY ineffective black undies on and nothing else. And trust me, I will get you there.
Can't wait to come in your mouth; I want to feel you swallow me down and tell me how you like it. Do you like doing that? Swallowing come down and tasting it on your tongue for ages afterwards? When I'm between your legs tonight, I'm going to make you come so hard you scream, and when I lick you out your gunna be so wet I'll be practically drinking you down. Then afterwards, I'll kiss you and you can tell me who tastes better; me or you?
Next time I see you baby, you're going to be screwed.
And I'm not talking metaphorical.
I like naughty naughty James -drools a bit-
Sorry it's been so long; as anyone whos read In Faith of Tomorrows most recent update will know, I've only got one hand functional at the moment as I'm recovering from a badly broken wrist. So updates may take a while
Mage of the Heart


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The property is situated in the heart of the city, in one of the most admired streets, excellent for its proximity to all services. FGG walk the street.
Availability upon agreement. The offer is subject to change of price or withdrawal without previous notice. The exposed dada including the dimensions are merely illustrative. In order to confirm the dimensions and juridical circumstances of the sales and purchase deal the Agency recommends to consult an independent competent professional.
The price does not include the taxes and costs. Corresponds to the purchaser the payment of the following taxes and costs: (i) in a first deliveries of residences (new residences) the Value Added Tax (IVA) and the Tax on Documented Legal Actions (AJD); (ii) in a second and subsequent deliveries of residences (used residences) the Property Transfer Tax (ITP); (iii) notary and registry tariff. For the rest of the information demanded by state and autonomous government regulations, please get in touch with the Agency.


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