Fifth Annual Risk Management and Drug Safety Summit Agenda
DAY ONE: Monday, Dec. 3 |
|
8:00 a.m. – 8:30 a.m. |
Registration and Continental Breakfast |
8:30 a.m. – 8:45 a.m. |
Chair: Welcome and Introduction |
8:45 a.m. – 9:45 a.m. |
CDER’s Efforts to Improve Risk Management and Drug Safety
Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited) |
9:45 a.m. – 10:30 a.m. |
Change Management Within Pharmacovigilance – Shifting our Focus Back to the Patient |
10:30 a.m. – 10:45 a.m. |
Morning Break |
10:45 a.m. – 11:30 a.m. |
Problems Encountered When Innovator and Generic Firms Have to Share a REMS Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara |
11:30 a.m. – 12:15 p.m. |
Top Legal and Compliance Challenges that Lie Ahead Stuart Kim, J.D., Senior Regulatory Counsel, Pharmaceuticals, Covidien |
12:15 p.m. – 1:15 p.m. |
Lunch Break |
1:15 p.m. – 2:00 p.m. |
How to Design an Effective ETASU with Integrated Digital Elements Attendees will learn:
Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health |
2:00 p.m. – 2:45 p.m. |
Maintaining Inspection Readiness While Guidelines Change: New EU Pharmacovigilance Legislation Attendees will learn:
Eleanor Segal, M.D., Biopharmaceutical Consultant, Segal PV Systems |
2:45 p.m. – 3:00 p.m. |
Afternoon Break |
3:00 p.m. – 3:45 p.m. |
Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements — An Effective Investigative Program Attendees will learn:
Ronald Buzzeo, RPh, Chief Compliance Officer, Cegedim Compliance Solutions, Cegedim |
3:45 p.m. – 4:45 p.m. |
Panel Discussion: Opioid REMS and What It Signals for the Future of REMS Moderator: Lynn Mehler, J.D., Partner, Hogan Lovells |
4:45 p.m. – 6:15 p.m. |
Networking Reception |
DAY TWO: Tuesday, Dec. 4 |
|
8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Chair: Welcome and Introduction |
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. Attendees will learn:
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 Attendees will learn:
|
10:45 a.m. – 11:00 a.m. |
Closing Comments |
11:00 a.m. |
Conference Adjournment |