戻る Agenda
Expediting Drug Development and Review for Serious Conditions
Session Chair(s)
Robert J. Temple, MD
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
FDA, United States
This forum will provide clarity about FDA’s expedited drug development and review programs and ways in which the EMA enables drug development. It will emphasize the importance of expediting drug development to address the critical need for new therapies to treat serious or life-threatening diseases that lack therapeutic alternatives.
Learning Objective : Discuss FDA’s and EMA’s processes and programs for expediting drug development. Identify the importance of these processes and programs to speed the development and review of drugs for serious or life-threatening diseases for patients who lack alternative therapies.
Speaker(s)
From Gatekeepers to Enablers: How Drug Regulators Respond to a Challenging and Changing Environment
Hans-Georg Eichler, MD, MSC
Austrian Association of Social Security Bodies, Austria
Consulting Physician
A Pharma Company Perspective on Expedited Development Pathways
Robert Metcalf, PHD
Eli Lilly and Company, United States
Senior Vice President, Clinical Design Delivery and Analytics, China and Japan
Panelist
Jeff Allen, PHD
Friends of Cancer Research, United States
President and Chief Executive Officer