Event Date/Time: Jun 13, 2007
Today Risk Management and Pharmacovigilance is an activity that the industry understands. Product safety is growing more complicated, with both trial safety and pharmacovigilance becoming more critical in the development and marketed use of products. In addition, according to CDER`s Senior Drug Risk Management Analyst, Joyce Weaver, of the 25 to 35 submissions that the FDA receives each year only about a quarter of those submissions are organized as the FDA has suggested. This "25% compliance rate with the current guidance" reveals that the "regulatory approach to risk management" at the FDA and at pharma companies is very much still in it`s infancy. There is still a lot of work to be done by the industry. This webcast discusses the intrinsic confines of risk management testing and speakers provide new methods for monitoring the evolving safety profiles of commercial product throughout its life cycle. In addition, hear a focused presentation on risk management and safety concerns impacting the industry.
If you are an executive or senior-level director from the pharmaceutical/biotech industries with responsibilities or involvement in the following areas:
Global Clinical/Medical Affairs
this webcast will benefit you. The conference will also benefit consultants and service providers working in the areas of risk management and pharmacovigilance.