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Session 2B: Round-table: Safety Risk Assessment in Drug Development

Day & Time:
October 21, 4:20PM - 5:50PM


Session 2B: Round-table: Safety Risk Assessment in Drug Development

Jose Luis Viramontes, MD
Director, Clinical Management, Mexico, Central America and the Carribean
PPD , Mexico

Norbert Clemens, DrMed,MD
Managing Director & Head of Clinical Development
CRS Clinical Research Services Mannheim Gmbh, Germany

Concerns about drug safety are one of the most important elements to overcome during the drug development process, and drug safety demonstration is nowadays a result of a careful, continuous, and systematic Risk Assessment approach. Safety studies now demand higher efforts, which are needed during all the clinical program, started since the compound selection and extended until the post-marketing follow-up. This is justified based on well known cases of drugs already in the market, that had to be withdrawn due to safety issues not detected or poorly documented during the pre-approval process, with a consequent huge economic and ethical impact. During the session, the principles of safety risk assessment during drug development will be discussed, and participants will learn from the experience of the speakers.

Presentation(s) & Speaker(s):
Pharmacovigilance Planning In Product Risk Management
Cecilia Calderon, MD
Former President, Mexican Pharmacovigilance Association (AMFV)

Latin America Perspective and Experience
Terezinha Teotonio, MSN,RN
PVG LatAm Manager, Brazil
PPD do BRA, Brazil

US Perspective and Experience
Nancy D. Smith, PhD
Independent Consultant
FDA Alumni, Temple University, United States