Risk Management and Drug Safety Summit Agenda
DAY ONE: Thursday, Oct. 1, 2009 |
|
8:00 a.m. – 8:45 a.m. |
Registration and Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome and Introduction by Chairpersons |
9:00 a.m. – 10:00 a.m. |
Risk Management in Drug Development — A European Perspective
|
10:00 a.m. – 10:30 a.m. |
Networking and Refreshment Break |
10:30 a.m. – 11:15 a.m. |
Risk Management Plans Post-FDAAA — An FDA Perspective
|
11:15 a.m. – 12:00 p.m. |
CDER’s Efforts to Improve Risk Management and Drug Safety
|
12:00 p.m. – 1:00 p.m. |
Lunch |
1:00 p.m. – 1:45 p.m. |
How Do We Know That REMS Are Effective? A Guide to Evaluating Risk Management Strategies
|
1:45 p.m. – 2:30 p.m. |
Developing, Implementing and Managing Complex REMS: Tysabri Case Study
|
2:30 p.m. – 3:15 p.m. |
Risk Management Approaches for Class II Opioid Analgesic Drugs
|
3:15 p.m. – 3:45 p.m. |
Networking and Refreshment Break |
3:45 p.m. – 4:30 p.m. |
The FDA in the Age of Obama
|
4:30 p.m. – 5:30 p.m. |
Managing Benefits and Risks Throughout the Product Life Cycle — Roche’s REMS and NEOS Experiences
|
5:30 p.m. – 7:00 p.m. |
Adjournment and Networking Reception |
DAY TWO: Friday, Oct. 2, 2009 |
|
8:00 a.m. – 8:45 a.m. |
Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome and Introduction by Chairpersons |
9:00 a.m. – 10:00 a.m. |
Panel Discussion: Developing REMS Early in the Life Cycle — Can Patient Understanding of Risks Be Determined During Clinical Trials?
Moderator:
Panelists: |
10:00 a.m. – 11:00 a.m. |
Panel Discussion: Achieving Predictability and Transparency in REMS
Moderator:
Panelists: |