Fifth Annual Risk Management and Drug Safety Summit Presentations
Click on the presentation title to view the presentation
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 |
9:45 a.m. – 10:30 a.m. |
Innovators, Generics, and REMS: Current and Emerging Issues |
10:45 a.m. – 11:30 a.m. |
Putting It All Together: A More Comprehensive Approach to Address the Issue of Prescription Opioid Abuse |
11:30 a.m. – 12:15 p.m. |
How To Design an Effective ETASU With Integrated Digital Elements |
1:15 p.m. – 2:00 p.m. |
Maintaining Inspection Readiness While Guidelines Change: New EU Pharmacovigilance Legislation |
2:00 p.m. – 2:45 p.m. |
Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements - An Effective Investigative Program |
3:00 p.m. – 3:45 p.m. |
Oncology Risk Evaluation and Mitigation Strategies |
3:45 p.m. – 4:30 p.m. |
Opioid REMS and What It Signals For the Future of REMS |
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 |
10:00 a.m. – 10:45 a.m. |
Pharmacoepidemiology In Safety Signal Assessment |