Drug Information Association, Inc. , Horsham, PA USA
May 3 2010 - May 5 2010
Learn the Practical Side of U.S. and International Safety Surveillance Participate in discussion on ways to apply the role of epidemiology and risk management, from both industry and FDA perspectives. WHAT YOU WILL LEARN
· Discover the historical and regulatory framework for safety surveillance and post approval marketing
· Describe the legal and regulatory importance of safety within a drug's overall profile
· Recognize US and international safety surveillance regulatory requirements
· Describe FDA initiatives for safety surveillance of drugs, biologics and vaccines
· Apply epidemiologic methods to drug safety surveillance
· Describe the concepts, tools, and strategies for risk management Event Code:
10452
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