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Clinical Risk Management: Design Considerations and Good Review Management Principles
Program Code:
REG070
Date:
Wednesday, May 9, 2007
Time:
4:00 PM to 5:30 PM
CHAIR
(S):
DR Taryn Rogalski-Salter, PhD, Director, Novartis Vaccines & Diagnostics, Inc., MA, United States
Jill Robinson, RPh, MBA, Vice President, Wyeth
SPEAKER
:
Patrick Caubel, MD, PhD, Associate Vice President, Sanofi Pasteur
Description
This session will present industry and regulators' experiences following implementation of three FDA guidances released in March 2005: premarketing risk assessment, risk minimization action plans and pharmacovigilance. The FDA (invited) and industry perspectives will be shared, including a discussion of good review management principles relating to risk-management submissions.
Objectives:
Outline the stages of clinical risk management.
Discuss considerations when developing a RiskMAP.
Discuss "best practices" for submitting RiskMAPs to the FDA.