Expediting Drug Development and Review for Serious Conditions
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
211
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
253A
CHAIR
:
Robert J. Temple, MD (SCHAGY), Deputy Center Director for Clinical Science, CDER, FDA, United States
Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
SPEAKER
(S):
Hans-Georg Eichler, MD,MSc (SPKAGY), Senior Medical Officer, European Medicines Agency, European Union, United Kingdom
Before becoming Senior Medical Officer, Dr Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research. His industry experience includes UK Ciba-Geigy and US Merck & Co
Robert Metcalf, PhD (SPKNON), Vice President, Global Regulatory Affairs - US, Eli Lilly and Company, United States
He is responsible for interactions with the FDA supporting new drug development and marketed products, including US product labeling, advertising and promotion, and regulatory policy. Hew also has responsibility for, global label management, global submission management, and global CMC.
Jeff Allen, PhD (SPKSUP), Executive Director, Friends of Cancer Research, United States
Jeff Allen, Ph.D., serves as the Executive Director of Friends of Cancer Research, a cancer research think tank based in Washington, D.C. that through policy and education brings together key stakeholders to overcome the barriers standing between patients and the most promising cancer treatments.
Description
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.