Details
- Type Event
- Date -
- Time -
- Location 1608 Rhode Island Ave NW, Washington DC 1608 Rhode Island Ave NW, Washington DC
About
This is Session 6 of 6. Must register for the entire 2024 Course and not per session.
Session 6 Co-chairpersons:
Charlie Gombar, PhD, ACDRS Director
Michael Dyszel, Project Excellence Lead, CSL Behring
Jean Lee, PhD, Consultant
Lecturers
|
CAPT Daniel Brum, PharmD MBA BCPS |
Chief, Project Management Staff, DRONP/ORO/OND/CDER/US Food and Drug Administration |
| Timothy A. Candy, PharmD MS BCPS | Principal Consultant, Regulatory Affairs, Opus Regulatory, Inc. |
|
Charlie T. Gombar, PhD |
ACDRS Director |
| Elaine Hughes, MBA | Vice President, WW Commercial Immunology & Neurology, BMS |
| Jean Lee, PhD | Consultant |
|
Craig H. Mallinckrodt, PhD |
Distinguished Biostatistician, Pentara |
| Eric Moss, MBA |
Lead Consultant, Strategic Development & Commercialization, Halloran Consulting Group |
| Mark Noguchi, MBA | Consultant |
| Alka Shaunik, MD MBA | Senior Director, Medical Affairs, CSL Behring |
Topics
- Portfolio management: principles, challenges, applications, and strategies
- Role of licensing in portfolio management
- Project management: principles, challenges, and strategies
- Judgment under uncertainty
- Integrated global strategy
- Turning strategy into plans
- Co-development and alliances
- Strategic marketing (commercial) role in development
- How to launch a new drug successfully into the market
- Risk communication and prescription drug promotion
- Promotional committee review simulation
- Leadership strategies in drug development and regulation
- Integrated evidence generation planning
- US Food and Drug Administration Management of the Review Process