09. May 2009

Three Key Aspects of Risk Management During Phase 3 Clinical Trials

Drug Information Association
ELISABETHENANLAGE 11 POSTFACH
4002 BAS SWITZERLAND
Phone: +41 (0)61 225 51 51
Fax: +41 (0)61 225 51 52
Email: MAIL: DIAEUROPE@DIAEUROPE.ORG

Link to the organizer
URL of event

Training

Research & Innovation

Registration required, Entrance fee

Kathleen Donner
Email: Kathleen.Donner@diahome.org.

Explore How Risk Management Strategies Evolve from Clinical Trials. Risk Minimization Action Plans (RiskMAPs) evolve as clinical and safety data emerge in a product’s lifecycle. RiskMAPs should begin to be developed as early in the product life cycle as possible, prior to an NDA filing. The phase 3 time period offers an opportunity to inform a post-marketing risk minimization program. This webinar will teach you how to: Incorporate a RiskMAP within a pre-marketing clinical trial; Evaluate clinical trial data as a basis for developing a RiskMAP strategy; and Use the phase 3 program to test and refine RiskMAP tools. Learning Objectives: At the conclusion of this webinar, participants should be able to: Explain why a RiskMAP is necessary within a pre-marketing clinical trial; Identify ways to use the Phase III time period for developing and refining a RiskMAP. and Discuss the opportunities and the challenges associated with translating pre-marketing risk management results into a RiskMAP for commercialization.

Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management United Biosource Corporation United States.