Monday, June 8

2:00-5:00pm

Recommended Pre-Conference Short Course
(SC5) COLLABORATING TO ACCELERATE THE ADOPTION OF NOVEL TECHNOLOGIES IN THE PRECLINICAL R&D PROCESS

RISK MANAGEMENT & STRATEGY

Best Practices in Developing Risk Management Programs – A Life Cycle Approach Working to Improve Prioritization and Decision Making in the Area of Drug Safety Steps to Identify Earlier and Better Assessment of Potential Risk of Compound in Development
Ernie Bush, Ph.D., Vice President, Collaborative Projects, Drug Safety Executive Council

Anthony Lassiter, Senior Medical Director, Product Safety and Pharmacovigilance, Astellas

Jack Reynolds, D.V.M., Chairman, Advisory Board, Drug Safety Executive Council

Axel Olsen, Ph.D., Executive Director, Pharmacovigilance/Risk Management, Quintiles

PRECLINICAL SAFETY STRATEGY & RISK MITIGATION

Designing Preclinical Studies to Best Elucidate Safety Profiles and Risks
Are There Ways for The Industry to Work Together through the Sharing of Toxicity Data?
Early Risk Identification using Novel Multidimensional Data Mining Technology
Mohammad Afshar, M.D., Chief Executive Officer, Ariana Pharma

Berengere Dumotier, Ph.D., Preclinical CardioSafety Expert, Preclinical Safety, Novartis

Mitchell Friedman, Ph.D., Director, Toxicology, Nonclinical Safety & Efficacy, Takeda

George McCormick, Ph.D., Vice President, Drug Safety & Disposition, Cephalon

Yvonne Will, Ph.D., Group Leader, Exploratory Safety Differentiation-Cell Based Assays, Pfizer

A HOLISTIC APPROACH TO DRUG SAFETY AND CROSS-FUNCTIONAL TEAMS

Developing a Cross Functional Team to Produce the Right Risk Management Plan
How Can We Improve Cross-Discipline Collaboration in Risk Management Planning?
Minimizing Legal Risks When Responding to an FDA REMS Request
Julio Caso, M.D., Vice President, Global Medical Affairs, Sepracor

Robert Di Giovanni, M.D., Brand Safety Leader, CVM/CD&MA, Novartis

Joanna F. Haas, M.D., Vice President, Pharmacovigilance, Genzyme

Judith Marquis, Ph.D., Group Vice President, Pharmacology and Preclinical Development, Genzyme

Drug Safety Executive Council

The Drug Safety Executive Council (DSEC) is a peer-to-peer membership of drug safety leaders with the common objective of advancing the development of better and safer medicines worldwide. Membership in DSEC is limited to leaders representing companies who develop small and large molecule pharmaceuticals only.