RMDS 2010 Agenda
DAY ONE |
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8:00 a.m. – 8:45 a.m. |
Registration/Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome and Introduction by Chairperson Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director, Global Regulatory and Health Policy, Porter Novelli |
9:00 a.m. – 10:00 a.m. |
CDER’s Efforts to Improve Risk Management and Drug Safety Attendees will learn:
Janet Woodcock, M.D., Director, CDER, FDA |
10:00 a.m. – 10:15 a.m. |
Networking and Refreshment Break |
10:15 a.m. – 11:15 a.m. |
Risk Management in Drug Development — A European Perspective Attendees will learn:
Sir Alasdair Breckenridge, Chairman, Medicines and Healthcare products Regulatory Agency, UK |
11:15 a.m. – 12:00 p.m. |
Beyond REMS – The Strategic Advantage Attendees will learn:
Juergen Schmider M.D., Ph.D., Corporate Safety Officer and Vice President Global Pharmacovigilance & Epidemiology, Cephalon |
12:00 p.m. – 12:45 p.m. |
Lunch Break |
12:45 p.m. – 1:00 p.m. |
Morning Recap and Introduction by Chairperson Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation |
1:00 p.m. – 1:45 p.m. |
REMS Evaluations: What Have We Learned? Attendees will learn:
Kelly Davis, M.D., Vice President, Safety, Epidemiology & Risk Management, United BioSource Corporation |
1:45 p.m. – 2:30 p.m. |
Practical Approaches to Lifecycle Signal Detection — Case Studies Where Data Mining Provided Valuable Insight Into Potential Signals Attendees will learn:
Elizabeth Garrard, Pharm.D., Chief Safety Officer, Drug Safety Alliance |
2:30 p.m. – 3:15 p.m. |
REMS: Beyond the Rhetoric Attendees will learn:
Rob Dhoble, President, Diversified Agency Services Healthcare, Omnicom Group, and Founder, Adherent Health, LLC |
3:15 p.m. – 3:30 p.m. |
Networking and Refreshment Break |
3:30 p.m. – 4:15 p.m. |
Safety Risk Management and Benefit/Risk Assessment: Considerations and Challenges in Oncology Attendees will learn:
Joseph Hoffman, M.D., F.C.C.P., Global Head, Safety Science, Oncology Safety Risk Management, Roche Pharmaceuticals and Genentech, a Member of the Roche Group |
4:15 p.m. – 5:00 p.m. |
Incorporating Risk Management Strategies Throughout the Product Life Cycle Attendees will learn:
Gary Appio, Pharm.D., US Safety Risk Director, Novartis Pharmaceuticals |
5:00 p.m. – 6:15 p.m. |
Adjournment and Networking Reception |
DAY TWO |
|
8:00 a.m. – 8:45 a.m. |
Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome and Introduction by Chairperson Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director Global Regulatory and Health Policy, Porter Novelli, former Associate Commissioner for External Relations, FDA |
9:00 a.m. – 10:00 a.m. |
Panel Discussion: Reading the Drug Safety Tea Leaves — Top Legal and Compliance Challenges that Lie Ahead
Moderator: Panelists:
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10:00 a.m. – 11:00 a.m. |
Panel Discussion: REMS “Veterans” Share Their Battlefront Tales
Moderator: Panelists:
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