text:
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my core skills
website copy
article writing
copy editing


text:
Con Etiquette (Record Release)
Wess Meets West, Venomspreader, Snowpiler
The Ballroom at The Outer Space
295 Treadwell Street
Building G
Hamden, CT, 06514
Doors 7:30 PM / Show 8:00 PM
This event is all ages
Wess Meets West began in 2005 as a studio project. From these inconspicuous beginnings came an amoebic evolution of various sounds, contributors, and influences that eventually resulted in their 2011 full length, "Chevaliers". With Chevaliers, Wess Meets West (Sam Stauff, Erick Alfisi, Nick Robinson, and Andrew Porta) move beyond any number of noisy "post rock" contemporaries in an attempt to harness a deeper narrative, one imbued with both history and odyssey. Whether on record or live, Wess Meets West consistently reaches the memorable while driving toward the intangible. Layers of ambient guitars, mirrored harmonies, swelling lows, and textured percussion mix with found sounds and electronics to create a density of sound that is otherworldly.
$10.00 - $12.00
Tickets Available at the Door
Upcoming Events
The Ballroom at The Outer Space
- Sorry, there are currently no upcoming events.

subset: commoncrawl


text:
Applied Roofing & Sheetmetal – Cool Ridge
WV Contractors try to get all available information about Applied Roofing & Sheetmetal, based in Cool Ridge.
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To get quick free quote or to check this Roofer availability you can contact Jasper Chambers directly by phone: (304) 787-4300 or find more contact options below.
Company name: Applied Roofing & Sheetmetal
Activity: Roofing Contractors
Attn: Jasper Chambers
209 Peters Ct
Cool Ridge, WV
County: Raleigh
ZIP Code: 25825-0000
Phone number: (304) 787-4300
About Applied Roofing & Sheetmetal:
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WV Contractors Information:
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technical recruiter contractor at Light.co
Palo Alto, CA, US
Light is rapidly growing. We're looking for a technical recruiter to help scale our Light team. Come join our small but mighty People Ops team in the search for amazing candidates who will be revolutionizing camera tech! We have a few hard-to-fill requisitions. We're ideally seeking a Talent Ninja who can think outside the box to source candidates outside the usual recruiting channels. Are you game for the challenge?
This position is a full-time contract position based in our Palo Alto headquarters.
We are not accepting resumes from agencies.
- Full cycle recruiting- soup to nuts!
- Partner closely with hiring mangers to understand open role requirements, and identify candidates
- Source candidates via the usual recruiting channels, and beyond
- Screen resumes, and interview talent to determine fit for open positions
- Provide a top-notch candidate experience to every one we interact with from first communication through onsite interview and offer
- Positively represent Light, and our employment brand
- Ensure accurate data integrity in the Applicant Tracking System (ATS)
- At least 3+ years of technical recruiting experience at a start-up; consumer electronics strongly preferred
- Proven track-record of managing a high-volume of roles; juggling skills admired
- Knowledge of tech, or ability to grasp technical concepts quickly
- Effective communication in a diverse environment
- Ability to work independently in a small People Ops Team
- Understands the importance of treating all candidates with equal respect, and kindness
- We are NOT accepting resumes from agencies.
some fun perks...
- Free catered lunches
- Fully-stocked kitchen of healthy drinks, fruits, and snacks
- Monthly Happy Hour Soiree
- Delicious morning coffee made by our own in-office coffee connoisseur
This full-time role based at Light's Palo Alto headquarters is ready to be filled immediately.
To reimagine photography, visit: https://light.co/.
We appreciate your interest in Light!
Individuals seeking employment at Light are considered without regard to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.
Powered by VentureLoop - Partner Company Sign In


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Your career's a blank canvas; start here
Imagine a career that is not about work, but about creation - in which each day means developing something unique.
Ruth Callaghan
Now how would you design a course that could prepare you for such a future?
That's the challenge taken up by the National Art School (NAS), which for 175 years has been helping develop and shape the careers of Australian artists.
Based in Sydney's inner-city, in a building that once was Darlinghurst Gaol, the National Art School is home to a community of art professionals.
Head of studies at NAS Simon Cooper says the school has produced artists who have illustrious careers, many working internationally or with work featured in some of the world's finest galleries.
But each started as a student with passion for what they wanted to create.
"Our student body is quite diverse – we have students of all backgrounds and a broad range of ages," he says.
"What they all have in common is their interest in developing a robust art practice that is informed by both the traditional skills of the studio and the possibilities of contemporary art practice today.
"Though they have a broad range of career ambitions, all have that drive to be a practising artist."
The NAS offers a Bachelor of Fine Art degree designed to provide students with the skills, knowledge and creative independence they need to work as an artist.
And while students can enter with a specialty in any artistic field, the course will give them a grounding in a range of core areas.
The first semester of the degree involves an exploration of studio practice in ceramics, painting, photomedia, printmaking and sculpture, before students narrow their focus to two areas and, finally, to their chosen specialisation.
It is a structure that Cooper says drives students to develop their skills, with small classes learning together under the guidance of established artists.
"Just like a professional career in the arts, study in this environment and at this level takes a lot of energy and commitment," he says.
"There's a lot to learn and there's plenty of challenges along the way, but creative people with an open and enquiring mind will find that it's an energising environment in which they develop rapidly."
Topping the nation
Students consistently rate the NAS highly and, in 2016, it recorded the highest result of any higher education provider in Australia for overall quality of educational experience.
In fact, its student satisfaction rates for teaching quality, learner engagment and student support sit about 15 per cent above the national average.
"Student feedback indicates a broad range of factors that — when combined — create a really positive student experience," Cooper says.
"At the core of that experience is a real sense of belonging within a creative community that values the interests and development of the individual.
"That kind of environment relies on keeping our course contact hours really high and our studio classes sizes small, ensuring that our teaching staff can engage with each student about their work.
"That environment also helps to cultivate peer learning, with students building strong relationships and engaging with other. These relationships tend to endure and transform into the foundations of a professional community that supports them beyond graduation."
Living the dream
Another key factor in the student experience is the opportunity to demonstrate their work.
The prestigious school attracts both national and international interest, and students can compete for art prizes, take space in galleries and exhibitions, or even become artists in residence at a range of international locations, from the Highlands of Scotland to the streets of New York.
"Our students are learning through the act of making artwork, guided by staff who are themselves practicing artists," Cooper says.
"There's always something happening to be part of. It's an incredibly dynamic and exciting environment for a young artist to be in."
For high school students considering the NAS, the first step is to explore the admission — conducted via a portfolio and interview rather than entry score alone.
Cooper says this is an important process.
"We believe that meeting people and talking to them about their work, interests and aspirations helps us to look beyond the applicant's ATAR and assess their aptitude and potential for artistic development.
"For many of our applicants this can be understandably daunting. Our admission interviews are held in early December and as we get closer to that date, in addition to the portfolio guidelines, we provide information sessions conducted by academic staff that can help applicants better understand the portfolio expectations and the interview process.
"The key message is to always present yourself as honestly as possible – don't try to presume what kind of work the panel is looking for.
"Some of our applicants have already had a lot of experience and some have had a very limited experience with art making.
"But the world doesn't need only one kind of artist."
To register your interest for Open Day, Saturday September 2nd, go to www.nas.edu.au/study/educational-outreach/openday/


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By offering the unusual Bromo Seltzer Tower to developers for housing, Baltimore officials may have uncovered a potentially explosive market. Think of all the other downtown landmarks that might be transformed into spectacular dwellings.
Imagine a small penthouse a top the historic Washington Monument. It would have a panoramic, 360-degree view of the city and its environs. Another possibility is the Shot Tower. Its apartments, however, would lack windows.


text:
2019 Summit Agenda
*All Summit Speaker Sessions are in the Grand Ballroom - Level 2 unless otherwise noted.
Tuesday, March 12, 2019
6:00 PM - 7:00 PM - Welcome Reception
Lobby Lounge
Join WBL for a networking reception to welcome those arriving early. Enjoy the opportunity to reconnect with your WBL peers and meet new attendees before the Summit formally begins!
7:00 PM - 10:00 PM - Dinner - ON OWN
We encourage those arriving on Tuesday to group together for dinner and enjoy the evening.
Wednesday, March 13, 2019
6:30 AM - 7:30 AM - Exercise Session
Location TBD
Clear your mind and prepare for the Summit with a morning exercise session.
6:30 AM - 7:30 AM - Networking Walk
Meet in Four Seasons Lobby
7:30 AM - 8:45 AM - Breakfast
LAW Restaurant
Enjoy breakfast with other attendees before the Summit kicks off at 9:00 AM.
8:30 AM - Welcome Desk Opens
Four Seasons Ballroom Foyer
Four Seasons Ballroom
9:00 AM - 9:30 AM - Opening Session - Welcome to the 2019 WBL Summit
Four Seasons Ballroom
Speaker: Lynn Shapiro Snyder, Founder & President, WBL Foundation, and National Health Care & Life Sciences Practice Leader, Epstein Becker Green
Join WBL Founder & President Lynn Shapiro Snyder for the kick-off of the WBL Summit! In this annual session, Lynn welcomes attendees to the Summit and sets the stage for the days to follow.
9:30 AM - 10:15 AM - Wednesday Morning Opening Session
10:15 AM - 10:45 AM - Networking Break
Four Seasons Ballroom Foyer
10:45 AM - 11:35 AM - Wednesday Morning Session
Speaker: Eve Burton, Senior Vice President and Chief Legal Officer, Hearst
11:35 AM - 12:30 PM - Speed Networking
Similar to speed dating, this speed networking session will pair you up with other attendees and allow you to network with each other in short intervals. Don't miss this opportunity to exchange business cards, share knowledge and insights on the current state of healthcare, and make connections the first day of the Summit!
12:30 PM - 2:00 PM - Networking Lunch
2:00 PM - 3:00 PM - Wednesday Afternoon Session
Moderator: Jodi Hubler, Managing Director, Lemhi Ventures
3:00 PM - 3:30 PM - Networking Break
Four Seasons Ballroom Foyer
3:30 PM - 4:30 PM - Commanding Influence Through Communication
Speaker: Jeanne Meserve, President, Shore Road Multimedia LLC and Director of Training, The Communication Center
Jeanne Meserve has had an impressive career as an Emmy and Peabody Award-winning anchor and correspondent for CNN and ABC News. Covering events of national and international significance, such as Hurricane Katrina and the death of Princess Diana, Jeanne has spent her career communicating for a living. She now travels the world as an Executive Communication Coach teaching others to be more effective, compelling communicators. Body language, tone, and inflection can have an enormous impact on whether and how your message is received. Jeanne will share practical techniques for developing a powerful presence and ensuring that you are heard. Whether you want to improve your in-person networking techniques, gain respect in a professional environment, position yourself for a new role or promotion, or break through barriers with your colleagues, this session will give you the tools to influence through effective communication.
4:30 PM - 6:00 PM - Break and Time for Private Meetings
5:00 PM - 6:00 PM - Membership Committee Meet-Up (invitation only)
6:00 PM - 7:00 PM - Sponsor Appreciation Reception (invitation only)
7:00 PM - 9:00 PM - Networking Dinner
This first dinner at the Summit is designed specifically to facilitate networking. Dinner will be served at stations, and we will encourage attendees to move about and meet new friends.
Thursday, March 14, 2019
6:30 AM - 7:30 AM - Exercise Session
Clear your mind and prepare for the Summit with a morning exercise session.
6:30 AM - 7:30 AM - Networking Walk
7:30 AM - 8:45 AM - Breakfast
LAW Restaurant
9:00 AM - 9:05 AM - Welcome to Day 2 of the 2019 Annual Summit
Four Seasons Ballroom
9:05 AM - 9:45 AM - Thursday Opening Session
Speaker: Jessica Harthcock, Founder & CEO, Utilize Health
9:45 AM - 10:30 AM - Thursday Morning Session
10:30 AM - 11:00 AM - Networking Break
Four Seasons Ballroom Foyer
11:00 AM - 12:00 PM - Thursday Morning Session
12:00 PM - 12:05 PM - Group Photo from the Podium
12:05 PM - 1:30 PM - Networking Lunch
1:30 PM - 2:45 PM - Peer Conferencing
2:45 PM - 3:00 PM - Networking Break
Four Seasons Ballroom Foyer
3:00 PM - 4:00 PM - Winning and Keeping Business
Speaker: Julie Hansen, Founder, Performance Sales & Training
Every day we find ourselves selling something – whether it's an idea, a new piece of business, or maintaining an important relationship. Maybe this is a professional role you've been thrust into without any past experience, or maybe you've spent half your career in sales. Have you ever wondered whether you are employing the most effective tactics when it comes to selling yourself or your business? Let Julie Hansen teach you how to sell without selling by building strong relationships and using natural aspects of your personality to develop rapport and trust. Based on her personal experience as an award-winning saleswoman and as a professional actress, Julie will help you learn how to be naturally persuasive by quickly establishing an emotional connection with customers and crafting a purposeful story that captures the client's interest. You will walk away from this session with tangible strategies for being an effective saleswoman and building strong relationships that last.
4:00 PM - 6:00 PM - Break and Time for Private Meetings
5:00 PM - 6:00 PM - Advisory Board Meet-Up
6:00 PM - 9:00 PM - Networking Dinner
The Terrace
Friday, March 15, 2019
6:30 AM - 7:30 AM - Exercise Session
Clear your mind and prepare for the Summit with a morning exercise session.
6:30 AM - 7:30 AM - Networking Walk
Meet in Four Seasons Lobby
7:30 AM - 8:15 AM - Breakfast
LAW Restaurant
8:30 AM - 8:35 AM - Welcome to Day 3 of the 2019 Annual Summit
Four Seasons Ballroom
8:35 AM - 9:30 AM - How Exceptional Leaders Influence, Inspire, and Mentor
Speaker: Carla Harris, Vice Chairman, Managing Director, Morgan Stanley
Nothing is more integral to the success of your organization than who is on your team. As a leader, how will you invest in their future, and keep them invested in your organization? Carla Harris is Vice Chairman, Managing Director, and Senior Client Advisor at Morgan Stanley and author of Expect to Win and Strategize to Win, two books on how great leaders influence, inspire, and mentor. Carla will share stories of her own missteps and victories, and how her "Pearls" of wisdom can translate into developing a pipeline of exceptional leadership. Walk away from this session with a better idea of what it means to be a leader who inspires, what sets a great sponsor apart from a good mentor, and the kinds of strategies and advice that will make you a leader that others are proud to follow.
9:30 AM - 9:45 AM - Networking Break
Four Seasons Ballroom Foyer
9:45 AM - 10:30 AM - The Inspiration Equation
Speaker: Kathleen Ellmore, Managing Director, Engagys
*All session times, speakers, topics, and descriptions are subject to change


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Wife: Anne Chute Stritch
Children with Anne: Thomasine Stritch
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- Anne Chute Stritch · Benalla, Australia
- Hilda Amelia Stritch (1882 - 1961) · Echuca, Australia
- Ferguson John Stritch · Echuca, Australia
- Hilda Farquaharson Stritch · Echuca, Australia
- Sydney Thomas Stritch (1886 - 1963) · Brighton, Australia
- Charles Stritch · Brighton, Australia
- Jane Miller Stritch · Brighton, Australia
- Charles James Stritch (1884 - 1967) · Echuca, Australia
- Charles Thom Stritch · Echuca, Australia
- Jane Miller Stritch · Echuca, Australia
- Rose Lillian Stritch (1885 - 1968) · Camberwell, Australia
- Auldist Willia Stritch · Camberwell, Australia
- William Harvey Stritch (1912 - 1969) · Morw, Australia
- Thomas Stritch · Morw, Australia
- Sarah Mitchell Stritch · Morw, Australia
- Mary Josephine Stritch (1901 - 1973) · Fitzroy, Australia
- Patrick Stritch · Fitzroy, Australia
- Mary Ann Buckley Stritch · Fitzroy, Australia
- Thomas Michael Stritch (1901 - 1974) · Tho, Australia
- Thomas Stritch · Tho, Australia
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- Jane Biehl (1863 - 1951) · Benalla, Australia


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Posted 9/26/18 (Wed)
By Betsy Ryan
Farmer Staff Writer
The Watford City Police Department (WCPD) announced last week that there has been changes made in the speed limit on two Watford City roads. Motorists will now get to drive 10 mph faster on portions of 4th Ave. NE and 2nd Ave. SW.
In the announcement of the changes, the WCPD stated that the speed limit changes come through a collaborative effort of the City of Watford City, the North Dakota Department of Transportation and the North Dakota Highway Patrol. After assessment of traffic throughout the city, the decision was made to adjust speed limits on only 4th Ave. NE and 2nd Ave. SW.
For the full story, subscribe to the McKenzie County Farmer


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Saskatchewan deputy premier Gord Wyant and trade minister Jeremy Harrison are heading on a week long trade mission to Israel.
The mission will allow the delegation to showcase Saskatchewan's agriculture sector, seek opportunities to increase trade and highlight investment opportunities in the province.
Over the last five years, Saskatchewan's exports to Israel have grown by 30 per cent in value, with 19 million dollars in exports last year.


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Did Paul Dillett Take Steroids?
People are wondering Is Paul Dillett has taken anabolic steroids to improve his aesthetic physique or Is he completely natural? Bodybuilding fans have often asked: Is Paul Dillett muscular physique is all about steroids or hardworking and dedication? Paul Dillett AKA "Freak-Einstein" is a retired Canadian professional bodybuilder, and founder of the world-renowned WBFF. He … Continue reading "Did Paul Dillett Take Steroids?"


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- September 16, 1940 - October 9, 2016
- Dickson, Tennessee
of Jean's Passing
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text: Hallvard Breien Furuseth: > > - Invoke an application call-back function with the error code and > > problem description text. If the error code is MDB_PANIC then > > the application knows that it needs to make final arrangements. > > Sounds good to me for now, since it doesn't mean walking all over > the code. mdb.c can just #define its own assert(). No error > code, the context is just "we're about to abort" and I don't know > of other planned callbacks which the code would help. > > /** User-settable callback for assert(), called before abort() > * instead of printing the message. > * > * assert(some user errors) might be unaffected. This hack > * should become obsolete as lmdb's error handling matures. > * @param[in] msg The assertion message, not including newline. > * @parem[in] info Currently NULL. Might change in the future. > */ > extern void (*mdb_assert_cb)(char *msg, void *info); > > (Or maybe call it -before- printing the message, you can abort or > longjmp yourself if you don't want the message.) Looks good. I'll code up an example implementation to set and use the callback. The "info" argument should be sufficient to figure out which database is failing. Wietse


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Student's Upload Attachment
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After submitting the application System generates Application form & unique student id. Please note this for future reference to track student examination information.
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11 Home Care Services for Seniors Serving Montcalm County, MI
Caring.com offers a free service to help families find senior care. To help you with your search, browse the 90 reviews below for homecare agencies in Montcalm County. On average, consumers rate home care in Montcalm County 4.5 out of 5 stars.
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JOHN McMURTRIE
- Arrest Number: 63010
- First Name: JOHN
- Last Name: McMURTRIE
- Middle Name: THOMAS
- Suffix:
- Current Age: 35
- Booking Date: 1/4/2018 12:20:00 AM
- Height: 5' 10"
- Weight: 180 lbs
- Hair Color: Brown
- Eye Color: Blue
- Race: White
- Sex: M
- Arresting Agency: CRAWFORDSVILLE POLICE DEPARTMENT
- Arrest Date: 01/04/2018
- City: Crawfordsville
- State: Indiana
booking information
JOHN McMURTRIE was booked on 1/4/2018 12:20:00 AM. McMURTRIE was arrested by CRAWFORDSVILLE POLICE DEPARTMENT in Crawfordsville, Indiana. McMURTRIE was 35 years old at the time of the arrest.
JOHN McMURTRIE may not have been convicted of the charges or crimes listed and are presumed innocent until proven guilty. Please contact the CRAWFORDSVILLE POLICE DEPARTMENT for more information regarding arrest records.
We are not affiliated with the CRAWFORDSVILLE POLICE DEPARTMENT and we cannot make any claims as to the validity of the records provided by them.


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Published byStefan Arne Modified over 4 years ago
Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases Karen Midthun, MD, Deputy Director Center for Biologics Evaluation and Research, FDA ICDRA Pre-Conference Berne, Switzerland September 15, 2008
Topics for today Approaches, needs, and opportunities to further enhance safety of vaccines and other biological products, with focus on post-marketing surveillance systems Importance of international collaborations Articulating a vision of an enhanced safety system
Vision for CBER INNOVATIVE TECHNOLOGY ADVANCING PUBLIC HEALTH Protect and improve public and individual health in the US and, where feasible, globally Facilitate the development, approval and access to safe and effective products and promising new technologies Strengthen CBER as a preeminent regulatory organization for biologics
Biological Products Regulated by CBER
Vaccines (preventive and therapeutic) Blood, blood components and derivatives Allergenics Cell and Gene Therapies Tissues Xenotransplantation Products Related Devices (including certain IVDs)
Major CBER Initiatives
Pandemic influenza and emerging threat preparedness Enhancing product safety Integrated safety teams and use of informatics Manufacturing and product quality activities Critical path Global collaboration
Enhancing Product Safety
Multi-disciplinary safety teams for vaccines, blood, and tissues (epidemiologists, clinical/product reviewers, compliance/manufacturing experts, communications) to improve acquisition, analysis, and communication of safety information Encompasses entire product life cycle and all data relevant to safety, manufacturing, and compliance Uses data to evaluate emerging safety issues Coordinates FDA response to emerging safety issues with other HHS agencies (CDC, NVPO, NIH), industry Enhances collaboration with other govt. agencies, WHO, and other entities on safety initiatives Proactive: develop research, policy, outreach agenda
Assuring Product Safety
Pre-licensure Evaluate clinical, nonclinical, product, and manufacturing data, including facility inspection Pharmacovigilance plan evaluated as part of biologics license application and informs post-marketing surveillance and studies Post-licensure Lot release Biennial inspections Evaluation of post-marketing adverse event reports (VAERS for vaccines and AERS for other products) and studies
Pharmacovigilance Plan (ICH E2E)
Basis for design of Phase 4 studies, passive surveillance and other components of pharmacovigilance plan is through analysis of Safety Specifications: Important identified risks Important potential risks Important missing information Manufacturer should consider actions to address any such concerns
Pharmacovigilance Plan (cont)
Staff member from the Division of Epidemiology is assigned to the Biologics License Application (BLA) review team Primary responsibility for review of pharmacovigilance plan and agreement with manufacturer regarding post-marketing safety studies is with Division of Epidemiology, working together with rest of multi-disciplinary review team As appropriate, pharmacovigilance plan is presented to FDA Advisory Committee, together with efficacy and safety data from BLA prior to licensure
Why do we need post-marketing surveillance?
Rare adverse events may not be detected in pre-licensure studies Why? Because even very large clinical trials have limitations. For example, to detect a doubling in an adverse event that occurs at a rate of 1/1000 would require a sample size of 50,000 (two-arm, power=80%, alpha=5%) The post-marketing surveillance activities described in the slides that follow focus on vaccines, but the same principles are applicable to other medical products
Post-Marketing Surveillance for Vaccines: Passive Approach
Vaccine Adverse Event Reporting System (VAERS) National system for passive surveillance of adverse events after vaccination established in 1990 in response to the National Childhood Vaccine Injury Act of 1986 Jointly managed by FDA and CDC VAERS contractor receives reports, manages report database, and conducts routine report follow-up Reports received from health professionals, vaccine manufacturers, and the public
Adverse Event Report Review
Manufacturer "15 day reports" of serious unexpected events and direct reports of death and serious adverse events are forwarded by VAERS contractor to assigned CBER staff within 1 business day Reviewed daily for unexpected events Follow-up with reporters as necessary Periodic reports/periodic safety update reports reviewed when submitted Weekly vaccine safety surveillance meeting
VAERS: Advantages National in scope, covers diverse populations
Able to detect rare adverse events Rapid detection of possible signals (hypothesis generating) Can assess adverse events by lot
VAERS: Limitations Reported diagnoses not verified
Lack of consistent diagnostic criteria Wide range of data quality Underreporting Inadequate denominator data (i.e., number of persons vaccinated) No unvaccinated control group No information on background rates of conditions in general population Usually not possible to assess whether vaccine caused the reported adverse event
Post-Marketing Surveillance for Vaccines: Active Approaches
Manufacturers' phase 4 studies FDA sentinel initiative Activities ongoing or under development with Centers for Medicare and Medicaid Services, Department of Veterans Affairs, Department of Defense large medical encounter and claims databases for controlled observational studies of specific safety issues Other public-private partnerships being sought FDA Amendments Act of 2007 prescribes an active post-market risk identification and analysis system intended to link and analyze safety data from multiple sources, with goal of including 25M patients by 2010 and 100M patients by 2012
Post-Marketing Surveillance for Vaccines: Active Approaches
CDC's Vaccine Safety Datalink (VSD) 8 geographically diverse health maintenance organizations that participate in large linked database that tracks Vaccination (exposure) Outpatient, emergency department, hospital and laboratory data (health outcomes) Demographic variables (confounders) Includes approximately 3% of U.S. population "Hypothesis testing" studies can be conducted
VSD Analyses: Advantages
All medical encounters are available at most sites Allows calculation of background rates of various conditions of interest Medical chart review is accessible Available for urgent studies
VSD Analyses: Limitations
Sample size may be inadequate for very rare adverse events (e.g., Guillain-Barre syndrome with incidence rate of 1-2/100,000 per year) Lack of demographic and socioeconomic diversity in HMO practices Variable accuracy of coded data used for studies Unvaccinated population may be small
FDA and CDC Interactions on Vaccine Safety
FDA and CDC, in conjunction with HHS and other agencies, work closely together on vaccine safety surveillance activities (e.g., VAERS, VSD and other active surveillance activities) and the analysis and communication of safety concerns
A Case Study: Rotavirus Vaccine and Intussusception (IS)
First rotavirus vaccine (Rotashield) licensed by FDA in August 1998 Pre-licensure: IS noted as possible AE, difference in rate between vaccine and placebo groups not statistically significant Post-licensure: likely excess of IS noted in VAERS, CDC-conducted epidemiological studies show elevated risk, and in October 1999, ACIP withdraws recommendation for vaccine and manufacturer voluntarily withdraws vaccine from market
How did this impact next rotavirus vaccine?
Second rotavirus vaccine (Rotateq) licensed by FDA in February 2006 Pre-licensure: very large safety study (70,000 infants, 1:1 vaccine to placebo), no increased risk of IS Post-licensure surveillance: VAERS, manufacturer's phase 4 study (44,000 infants) and CDC's VSD study (90,000 infants) To date, no signal of increased risk of IS after Rotateq (Pediatrics 2008;121: ) Updates communicated through changes to labeling and patient information, Public Health Notification, MMWR publication
Other Recent Examples of Vaccine Safety Issues
Possible increased risk of Guillain-Barre syndrome after Menactra (quadrivalent meningococcal conjugate vaccine) Possible increased risk of febrile seizures after Proquad (combined Measles, Mumps, Rubella and Varicella Vaccine) Update on the safety of Gardasil (human papillomavirus vaccine)
Global Collaboration CBER is a WHO Collaborating Center
Expert Committee on Biologic Standards Strategic Advisory Group of Experts Global Advisory Committee on Vaccine Safety Global Collaboration on Blood Safety and Blood Regulators Network Expert consultation in specific product areas Participates in WHO prequalified vaccines program Participates in WHO teams to assess competency of national regulatory authorities (NRA) around the world Training: Works with WHO Developing Countries Vaccine Regulators Network to help build global regulatory capacity of NRAs with regard to vaccines
Global Collaboration Information sharing arrangements and engagement in priority areas with various regulatory authorities and WHO Brighton collaboration for standardized case definitions of adverse events following immunization CIOMS vaccine safety working group Partnering with WHO and NGOs to explore additional means of providing global regulatory assistance and capacity building International Conference on Harmonisation Pharmaceutical Inspection Cooperation/Scheme
FDA Amendments Act (2007): Some Highlights
Pediatric Research Equity Act: Pediatric studies required with application or supplement for new active ingredient, indication, dosage form, dosing regimen, or route of administration, unless deferral or waiver granted Safety: FDA to require post-marketing studies or clinical trials at time of approval, or after approval, based on certain safety concerns (e.g., to assess known serious risk or signal of serious risk, or to identify expected serious risk if data indicate such potential)
FDA Amendments Act (cont)
Safety Labeling Changes: FDA to require if new safety information needs to be included, specific timelines noted Risk Evaluation and Mitigation Strategies: FDA can require at time of or after approval, if deemed necessary to ensure that benefits outweigh risks Active Post-market Risk Identification and Analysis System: to link and analyze safety data from multiple sources, with goal of including at least 25M patients by 2010, at least 100M patients by 2012
Vision for Post-Market Surveillance
All patients' vaccinations and health outcomes are immediately and continuously accessible in automated database(s) allowing optimal detection and analysis of potential problems in vaccine safety Not there yet – both major limitations and opportunities in current health information systems Both problems and solutions to enhance vaccine safety information and analysis are applicable to safety initiatives for other medical products
Post-Market Surveillance: Needs
Access to more patients and better data Given diversity of data sources, innovative approaches to retrieval of key data may have great potential vs. single unified system Better background rates, comparable "control" populations More consistent event/disease nomenclature, IT architecture, data interchangeability, quality Increase in "non-medical" data sources – e.g., pharmacy, supermarket, employer vaccination
Post-Market Surveillance: Opportunities
Access to additional health systems data: CMS, VA, DoD, managed care organizations Access to global data: regulatory, inspectional, health systems, international surveillance and pharmacovigilance Better analytic tools and methods
Communications and Transparency
Early and continuing communication of possible safety signals is expected and beneficial to consumers, health care providers, science Critical to confidence in integrity of vaccine safety system, government and industry Enhances reporting and informs decision-making of consumers and health care providers Initial information and medical/scientific opinion and assessments often evolve Conveying uncertainty of risk difficult, includes potential for decreased use of safe and effective products
Summary Pre-licensure clinical, product, and manufacturing data are critical foundations for evaluating the safety and effectiveness However, post-licensure surveillance is essential to assure product safety Vaccines and other medical products have risks that may include rare serious adverse events not detected in pre-licensure studies Government agencies play an important role in monitoring, analyzing, and communicating re safety of vaccines and other medical products
Summary (cont) Passive and active surveillance, including observational studies, after licensure are needed to detect and evaluate vaccine safety concerns Need for robust, continuously operating and technologically advanced safety monitoring systems that include epidemiological, clinical, and laboratory assessments of causality Public communication and engagement regarding vaccine safety concerns is critical to maintaining confidence in the vaccine safety system, optimal vaccine coverage, and the public health
Acknowledgments Robert Ball, MD, MPH, ScM Jesse Goodman, MD, MPH
John Iskander, MD, MPH Douglas Pratt, MD, MPH Joan Blair, MA
Thank you! We are actively engaged in assuring the safety, effectiveness, and availability of products that touch so many lives and are critical for public health and preparedness Emerging threats, technologies, and opportunities demand constant renewal of scientific expertise and capacity The challenges and opportunities for leadership and public health are truly global – and collaboration is key! CBER: INNOVATIVE TECHNOLOGY ADVANCING PUBLIC HEALTH
CBER Contact Information Manufacturers: Consumers, health care professionals: Phone:
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Switzerland (where it is equivalent to a société à responsabilité limitée) and Liechtenstein. In the United States, the equivalent type of entity is the limited liability company (LLC). The name of the GmbH form emphasizes the fact that the owners (Gesellschafter, also known as members ) of the entity are not personally liable for the company's debts.[1][2] GmbHs are considered legal persons under German and Austrian law
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Navigate: Homage / News / Swimming pool robot cleaner MAX 1 is awarded with the Excellence in Design (EID) Gold Award 2013
Swimming pool robot cleaner MAX 1 is awarded with the Excellence in Design (EID) Gold Award 2013
The pool cleaner MAX 1of AstralPool has received the Excellence In Design (EID) Gold Award 2013 in the category of water treatment products. This award acknowledges excellence in the field of innovation, design and functionality among industrial products for consumers and/or companies.
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Bright Bankruptcy Home >> TEXAS >> WAXAHACHIE
Call (469) 607-9300 To Learn About Fast, Affordable Debt Relief.
The stress of mounting debts that you cannot pay, as well as cash deficiencies have you worrying about your family's urgent demands as well as your children's coming future. You're facing approaching home foreclosure and auto repossession. After way too many sleepless nights and long days of distressing personal concerns, you've eventually gotten to the place where you recognize you need expert support to cope with your liabilities.
Take a rest and have a think momentarily.
You're going to find the support you require, and you're going to have the capacity to sustain your family. It's as quick and easy as acquiring a Waxahachie bankruptcy to lawyer that can help and you'll be back on your feet and providing for your family's needs once more in no time at all.
This is a pretty trying moment for you, and you don't want to have to fret about whether your attorney knows what he or she's doing or not. Precisely what you do not require is somebody who does not specialise in personal financial legislation. And you need to have someone who comprehends the variety of bankruptcy chapters from top to bottom as well.
Precisely what you are trying to find is local attorneys which have prior experience and a proven record in obtaining acceptable end results for their bankruptcy customers. Explore on the web to see if you can discover any reviews and testimonials concerning the attorneys you find, and also inquire around your friends and family in order to find if they have actually worked with them. And you likewise ought to make certain they know how to stop home foreclosure and vehicle repossession if you are at probable possibility of confiscation.
You should firstly look for the suggestions of your close circle of household and pals to find a good attorney. Make sure that your time isn't squandered by reminding them that it's attorneys who specialize in insolvency that you're searching for. Ask your contacts things like, did they feel comfy throughout the procedure?
If you're struggling Asking your routine everyday business contacts can be an useful resource, and one that s seldom made use of by people. There's no requirement to do all the heavy lifting if it is currently done for you.
Another technique of finding a lawyer is to have a look at the local Waxahachie bar association directories. This will be a long list of lawyers in your city, in addition to their relevant specialist areas of the law. You'll get them online and in your library, and they are searchable by postal code. Although these lists are quite thorough, there are no recommendations or track records offered therefore beware who you choose to approach, and searching with your questions.
Chapter 7 and chapter 13 insolvency are the two chapters that you will need to look for eligibility for as a consumer. We have actually laid out the fundamentals for you here ...
Chapter 7 Bankruptcy.
If you learn that you can get insolvency under chapter 7 then this typically means you can be sure of owing absolutely nothing from your discharge onwards. Although sometimes there will be unique nonexempt properties that can be seized and offered for sale. Your legal representative will explain this even more.
Chapter 13 Bankruptcy.
Your lawyer will go over this at length with you, however here's some brief guidance. Chapter 13 is the chapter where you will agree a repayment plan with the court. If the court concurs it is appropriate then you will pay them in monthly deductions from your wage packet.
After you get some recommendations, you'll have to learn if you can pay for the bankruptcy procedure by discovering just how much it's going to cost. It's best to not rely on one quote but attempt to get a couple of from different law offices for the procedure you will want them to undertake. Whether you are qualified for chapter 7 or 13 there will be a different charge required. You can be sure that various regional courts will charge various amounts also.
Fees for bankruptcy will differ from one state to another. You'll need to reserve money to spend for counseling, court costs and legal fees, which alone will total around $2000 for chapter 13.
In addition to learning exactly what the attorney charges are, you are going to wish to know how and when the legal representative will need you to pay. You might only be needed to pay a little up-front fee then the rest in affordable instalments. The Waxahachie court may choose that even paying the legal charges would produce further difficulty for you and let you pay the whole thing in affordable monthly instalments.
You will need to know what you are getting for your cash from your lawyer. They will obviously undertake all of the legal deal with your behalf, going to court with or instead of you, developing a payment strategy if you are eligible for chapter 13, and submitting all the kinds needed by your court.
Satisfying possible lawyers.
There are several aspects to think about once you begin to shortlist the lawyers for the next phase. You know that they must be discrete and conscious of your needs, along with being appropriately qualified in financial law. Individuals whom you trust will most likely have been recommended to you and after that you will have browsed the web to see what other individuals say about them. They must be experts in their field and their charges should be inexpensive. Upon this, they will probably get you an appointment for the Discovery Meeting at their Waxahachie office, free-of-charge.
This initial assessment is for you. It's yours to utilize to discover out if you desire to work with these people. You have to choose for yourself which elements are crucial for you so make a list of questions that you desire answered. Order them in terms of top priority for you and make certain you get them all answered adequately and appropriately. This is a really crucial phase of the procedure so don't skip it.
There will be more than simply your lawyer dealing with your case so get a hold of the names of the paralegals in the firm also. You'll have to be positive that they understand insolvency law in general, and chapter 7 and 13 specifically. Learn how the work will be split up between the different members of personnel. And learn exactly what rights you're entitled to.
Ask the lawyer outright if he has enough time to devote to your insolvency case; this is actually crucial. You also have to discover how long you'll be kept waiting on a return call and what the normal waiting time is for a visit. And find out exactly what his basic availablity is.
You have to discover as much as you can about the law, and their firm so now's your chance to get into the nitty gritty with your legal representatives about the law and their company. The sort of attorney you want representing you is the type of attorney who does not shirk even the most hard concerns about their company so bear that in mind.
So you've found a legal representative who has the competency to manage your case however does not have the level of sensitivity you need, then it's time to look in other places. If your lawyer can't interact the insolvency law in basic terms then it most likely suggests he doesn't comprehend it well enough to take on your case. The last thing you need at the moment is the tension of not understanding your case. You need a friendly person who understands you and is professional enough to be able to assist you.
Selecting your attorney.
So you've done everything you possibly can to set your mind at ease, consisting of following all our advice, and picked an attorney. Ask your lawyer for the agreement and let's get cracking.
Ask your attorney to draw up the necessary documentation, including the contract.
The agreement will include a scope of works that you can follow along throughout the process to make sure it is running smoothly and on time. The contract will likewise include your expenses and payment dates.
Take a huge cheer from us ... well done! You are now on your way to a brand-new start with monetary liberty.
If you want to come along and talk with us about the way forward with our company, give us a call and organize your very own discovery meeting.
There are loads of large law businesses throughout America and Waxahachie and we ourselves have lots of workplaces in all states. Provide us a possibility and you will not regret it. Give us a phone and have an informal chat today.