Navigation Links
DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation

Recent reports have brought attention to the Food and Drug Administration's (FDA's) plan to list those drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians, and patients.

Horsham, PA (Vocus) September 24, 2008 -- Recent reports have brought attention to the Food and Drug Administration's (FDA's) plan to list those drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians, and patients.

The [DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation] (October 14 -15; Arlington, VA) will stimulate discussion between FDA and industry participants for proactive planning of safety evaluation. This will include planning for data collection, integration, analysis (including meta-analysis), and reporting. Featured session topics will include:

  • Challenges with and opportunities to improve pre-marketing safety planning, evaluation, and reporting
  • Combining safety data at a development program level
  • How to improve safety data analysis and reporting
  • Safety boundaries for Data Monitoring Committees (DMCs)
  • Planning for effective meta-analysis
  • Regulatory decision making based on meta-analysis results
  • Meta-analysis for rare events from clinical trials
  • Meta-analysis for observational data

Dr. Janet Woodcock, Director, CDER, FDA, will deliver the keynote address.

About the [Drug Information Association (DIA)]
DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit or call 215-442-6100.

Joe Krasowski


Read the full story at

Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved

Related medicine news :

1. More proof needed of safety and quality of electronic personal health records
2. Back to School Means Backpack Safety
3. Seniors Need a Safety Plan in Face of Disasters
4. New Survey Shows Americans are Still Concerned About Food Safety, Yet Still Not Smart About What They Like to Eat
5. National Patient Safety Foundation Partners with Vocera Communications
6. QI projects may -- or may not -- improve patient safety and outcomes
7. The National Center for Missing & Exploited Children, Wal-Mart, and Abbott Host Child Safety Events
8. Cutting Salt Wont Affect Foods Safety
9. Microsoft Helps Developers of Clinical User Interfaces Improve Efficiency, Patient Safety With Free Toolkit
10. The Risk Management and Patient Safety Institute Announces Annual Health Care Risk Conference Dates
11. Blue Cross and Blue Shield Initiatives Recognized for Increasing Patient Safety and Efficiency
Post Your Comments:
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
(Date:6/23/2016)... June 23, 2016  Experian Health, the ... transforming the patient payment and care experience, ... new products and services that will enhance ... cycle offerings. These award-winning solutions will enable ... remain compliant in an ever-changing environment and ...
Breaking Medicine Technology: