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Radisson Blu

Nov 25, 2019 9:00 AM - Nov 26, 2019 5:30 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

Advancing CMC Workshop

Accelerated pathways, EU CMC trends and global opportunities

Session 3: Opportunities for CMC in Accelerated Development Programmes Part 2

Session Chair(s)

Susanne  Ausborn, PhD

Susanne Ausborn, PhD

Global Head International Regulatory Policy

Roche, Switzerland

Frank  Montgomery, PhD

Frank Montgomery, PhD

Global Head Regulatory CMC, GRAPSQA

AstraZeneca, United Kingdom

Session 3: Opportunities for CMC in Accelerated Development Programmes Part 2

Speaker(s)

Ghadeer  Al-Sheikh Salem

Panel Discussion and Q&A, with the participation of the Regulators present at Session 1 and the Industry Representatives from Session 2

Ghadeer Al-Sheikh Salem

Jordan Food and Drug Administration, Jordan

Head, Originator and Biological Drugs Division, Registration Department

Dmitriy  Rozdestvensky, MD, PhD

Dmitriy Rozdestvensky, MD, PhD

Eurasian Economic Commission, Russian Federation

Head, Division for Coordination of Common Market for Drugs and Medical Devices F

Veronika  Jekerle, PhD, RPh

Veronika Jekerle, PhD, RPh

European Medicines Agency, Netherlands

Head of Pharmaceutical Quality

Bernardo  Moreira

Bernardo Moreira

Brazilian Health Regulatory Agency (ANVISA), Brazil

Second Directory Assessor (DIRE2)

Fabian  Schwarb, PhD

Fabian Schwarb, PhD

Siegfried AG, Switzerland

Global Head Regulatory Affairs

T.  Venkateshwaran, PhD

T. Venkateshwaran, PhD

Merck & Co., Inc., United States

Vice President and Global Head CMC Biologics, Medical Devices and Comb

Florence  Salmon

Florence Salmon

Novartis, Switzerland

Director Regulatory Affairs CMC

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