Navigation Links
Food and Drug Law Institute Sponsors Colloquium on Communicating Risk/Safety Drug Information
Date:11/26/2007

Landmark Meeting Dec. 6, 2007 to Address FDA's Next Big Challenge

Is the Food and Drug Administration Effectively Communicating Risk/Safety Information on Drugs and Devices to Physicians and the Public?

WASHINGTON, Nov. 26 /PRNewswire-USNewswire/ -- In 2005, FDA banned the use of a device that repairs damaged cells and treats cancer through electromagnetic waves, known as the Pap-Ion Magnetic Inductor (PAP-IMI), because of its apparent connection to patient injuries and death. However, on November 19, 2007 The Seattle Times reported that the PAP-IMI is still in use in at least five states, and that FDA has yet to issue a public statement about the risks linked with the device.

FDA's task is indeed daunting. A panel of experts will discuss and debate the issue of risk communication at a landmark colloquium, Communicating Risk/Safety Information: How FDA Is Meeting the Challenge, sponsored by the Food and Drug Law Institute (FDLI), Dec. 6, 2007, in Washington, D.C.

This meeting is the third in a series of colloquia sponsored by FDLI. Under its new strategic direction, FDLI is committed to using the colloquium series as a neutral forum to address the legal, regulatory, policy and practical implications of technological innovations affecting the food and drug industry.

As the public becomes more concerned about whether it's safe to take --- or stop taking --- their medications, FDA is making risk communication a top priority. The agency has formed an advisory committee on communication and implementing new Congressional requirements on risk evaluation. This program seeks to clarify what that means for those who must deal with adverse events and contraindications every day.

Colloquium attendees will receive:

-- Results of a study on how FDA handled the antidepressant drug controversy;

-- Analysis of the new risk evaluation and mitigation strategy (REMS) requirements;

-- Tips on developing world-class risk/safety and communications plans;

-- Vital information on FDA's new Risk Communications Advisory Committee;

-- An inside look at FDA's overall risk communications strategy from its Director of Risk Communication, Nancy Ostrove; and

-- Excerpts from FDA's Response to the IOM's Report on Drug Safety.

The expert panel includes:

-- Nancy Ostrove, Director, Risk Communication, FDA;

-- Randall Lutter, Deputy Commissioner for Policy & Planning, FDA;

-- Stuart Pape, Managing Partner, Patton Boggs;

-- Robert Dormer, Partner, Hyman Phelps & McNamara;

-- Grace-Marie Turner, President, Galen Institute;

-- Susan Newberry, Senior Vice President, Director, D.C Healthcare Practice, Ketchum Communications; and

-- Kelly Posner, Associate Professor, Columbia University.

Registration is $295 for FDLI members, $395 for non-members. Attendance is limited, so registrants are strongly urged to sign up early.

To register, visit http://fdli.org or call +1-800-956-6923 or +1-202-371-1420.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.


'/>"/>
SOURCE Food & Drug Law Institute
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Mayo Clinic Multidisciplinary Simulation Center Receives Distinction as an ACS-Accredited Education Institute
2. The Risk Management and Patient Safety Institute Announces Annual Health Care Risk Conference Dates
3. LifeNet Health Establishes The Skin & Wound Allograft Institute
4. Statement from Employment Policies Institute on Senator Hillary Clintons Health Care Plan
5. CAS Medical Systems, Inc. Awarded $2.8 Million Grant by National Institutes of Health
6. Portico Systems to Share Provider Network Management Best Practices at Institute for International Research
7. The Integrated Benefits Institute Offers Largest Benchmarking Database in U.S. Spanning Disability and Workers Compensation Programs
8. The Cooper Institutes FITNESSGRAM Selected as Statewide Physical Fitness Assessment Tool
9. Bullying Prevention Institute Designed to Empower Change in Schools
10. Southern Research Institutes Neurodegenerative Disease Drug Discovery Program Receives National Institute of Mental Health Funding
11. Corey McPherson Nash Develops Case Statement for Dana-Farber Cancer Institute Capital Campaign
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... ... spark a conversation on the current obstacles facing infection prevention and offer strategies ... deaths caused by these infections. , The print component of “Fighting Infection” ...
(Date:3/24/2017)... ... 2017 , ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce ... The clinic is the group’s 7th location in San Antonio and 23rd in Texas. ... provide care from the clinic, which opened March 22, 2017. , The ...
(Date:3/24/2017)... ... 2017 , ... As the standards bearer of advanced cancer ... positions them as the go-to thought leader in all matters concerning oncology nursing. ... always-on, always-fresh news, views and advocacy engine, called ONS Voice. , The ONS ...
(Date:3/24/2017)... ... March 24, 2017 , ... Gastro Health (“GH”) ( ... patients for colonoscopy at the HyGIeaCare® Center that is to be located adjacent ... , The HyGIeaCare® Prep, cleared by the U.S. Food and Drug Administration ...
(Date:3/24/2017)... ... , ... “Vintage and Harvest A Cultivation of Christian Love” is the creation ... North Carolina with his wife, Anna Marie. He and his wife are the proud ... also the author of “Shadow and Substance.” , “Love, the agape kind, is seen ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... , March 23, 2017  HealthMine surveys with 9,250 ... revealed that health plan members want help from their ... stay engaged in their health, 2) help closing gaps ... platform for health and 5) relevant, real-time guidance. Meeting ... lowering healthcare costs. A Reason ...
(Date:3/24/2017)... , March 23, 2017  Provectus Biopharmaceuticals, Inc. ... "Company"), a clinical-stage oncology and dermatology biopharmaceutical company, ... Financing Commitment Term Sheet (the "Definitive Financing") it ... of the Company,s stockholders, who are referred to ... a Form 8-K filed with the Securities and ...
(Date:3/24/2017)... 24, 2017 The Board of Directors of ... Report 2016 including the complete 2016 Annual Accounts with notes. ... Nordic Nanovector,s website in the section Investor Relations/Reports and presentations/Annual ... ... Kvåle, Chief Financial Officer Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com ...
Breaking Medicine Technology: