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

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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.

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 http://www.diahome.org or call 215-442-6100.

Contact:
Joe Krasowski
215-293-5812

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