The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols
Track
:
Track 02: Project/Portfolio Management and Strategic Planning
Program Code:
203
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
203
CHAIR
:
Anne B. Cropp, PharmD (SCHNON), Executive Director, Pfizer Inc, United States
Anne Cropp is Clinical Group Head at Pfizer Inc. She serves as cross-line expert for various operational efficiencies and is Business Lead for a global Protocol Development Process Improvement effort that has significantly improved cycle time of protocol development and reduced amendments.
SPEAKER
(S):
Anne B. Cropp, PharmD (SPKNON), Executive Director, Pfizer Inc, United States
Anne Cropp is Clinical Group Head at Pfizer Inc. She serves as cross-line expert for various operational efficiencies and is Business Lead for a global Protocol Development Process Improvement effort that has significantly improved cycle time of protocol development and reduced amendments.
Stella Stergiopoulos, (SCHSUP), Project Manager, Tufts Center for the Study of Drug Development, United States
Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmaceutical outsourcing practices, duration metrics, resource management, and protocol design.
Badri Rengarajan, MD (SCHNON), Senior Medical Director, Archimedes Inc., United States
• 10 years experience across product development strategy & new product planning, regulatory affairs, business development • Director, BD and Market Research, Nodality • Regulatory Team Leader, Genentech • Engagement Manager, McKinsey • A.B., Biology and Public Policy, Harvard • M.D., Yale
Description
This session will focus on assessing the impact of implementing legislation-required changes to protocols, lessons learned, and points for consideration to help prepare your organization for future similar challenges.