Fifth Annual Risk Management and Drug Safety Summit Presentations

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DAY One: Monday, Dec. 3, 2012

8:45 a.m. – 9:45 a.m.

Change Management Within Pharmacovigilance – Shifting our Focus Back to the Patient
Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company

9:45 a.m. – 10:30 a.m.

Innovators, Generics, and REMS: Current and Emerging Issues
Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara

10:45 a.m. – 11:30 a.m.

Putting It All Together: A More Comprehensive Approach to Address the Issue of Prescription Opioid Abuse
Stuart Kim, J.D., Senior Regulatory Counsel, Pharmaceuticals, Covidien

11:30 a.m. – 12:15 p.m.

How To Design an Effective ETASU With Integrated Digital Elements
Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health

1:15 p.m. – 2:00 p.m.

Maintaining Inspection Readiness While Guidelines Change: New EU Pharmacovigilance Legislation
Eleanor Segal, M.D., Biopharmaceutical Consultant, Segal PV Systems

2:00 p.m. – 2:45 p.m.

Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements - An Effective Investigative Program
Ronald Buzzeo, R.Ph., Chief Compliance Officer, Cegedim Compliance Solutions, Cegedim

3:00 p.m. – 3:45 p.m.

Oncology Risk Evaluation and Mitigation Strategies
James Frame, M.D., FACP, Medical Director, David Lee Cancer Center, Chair ASCO REMS Working Group, President, West Virginia Oncology Society

3:45 p.m. – 4:30 p.m.

Opioid REMS and What It Signals For the Future of REMS
Lynn Mehler, J.D., Partner, Hogan Lovells

DAY Two: Tuesday, Dec. 4, 2012

9:15 a.m. – 10:00 a.m.

Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D — Results From a 2011 Pilot Program Conducted Among PhRMA Member Companies
Richard Hermann, M.D., M.P.H., Safety Science Physician, Patient Safety, Global Regulatory Affairs, AstraZeneca

10:00 a.m. – 10:45 a.m.

Pharmacoepidemiology In Safety Signal Assessment
David Lilienfeld, M.D., Principal, Write for the Pharm, LLC