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DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation
Date:9/24/2008

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.

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 http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17308&eventType=Meeting [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 http://www.diahome.org/ [Drug Information Association (DIA)]
DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory
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