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An Insider’s View of Cooperation Between the EMA and CDER/FDA: Question Time
Session Chair(s)
Sabine Haubenreisser, PhD, MSc
Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands
Sandra Kweder, MD
Principal, Drug and Biological Products
ELIQUENT Life Sciences, United States
New this year! Join us for this unique opportunity that includes members from EMA and CDER/FDA Leadership. This first of its kind forum will provide an opportunity for both agencies to discuss and explore at a roundtable discussion areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both agencies who have been at the forefront of EMA/CDER/FDA collaboration will explore topics such as pharmacovigilance, adaptive pathways, quality by design, and patient involvement in the development of medicines.
The audience will be invited to submit questions of general interest. Please come prepared with your questions for the EMA/CDER Question Time panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diaglobal.org, and include “EMA/CDER/FDA Question Time” in the subject line.
Learning Objective : Summarize key issues discussed by EMA and CDER/FDA; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy and safety; Identify how to engage both agencies in the development of a medicine at the same time.
Speaker(s)
Panelist
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Panelist
Christine Moore, PhD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Panelist
Theresa Mullin, PhD
FDA, United States
Associate Center Director - CDER
Panelist
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
Panelist
Enrica Alteri, MD
European Medicines Agency, Netherlands
Head, Human Medicines Research and Development Support Division
Panelist
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Panelist
Emer Cooke, MBA, MSc
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director