Date(s) And Time(s):
Sep 20 2010 9:00AM - Sep 22 2010 12:00PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research, Regulatory Affairs

Overview:

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

Learning Objectives:

At the conclusion of this course, participants should be able to:

Discuss the historical and regulatory framework for safety surveillance and postapproval 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

Target Audience:

Pharmacovigilance professionals
Clinical development professionals
Medical affairs professionals

Event Code:
10453

Contact Information:

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org

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