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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 8: Updates from Health Authorities

Session Chair(s)

Frank  Montgomery, PhD

Frank Montgomery, PhD

Global Head Regulatory CMC, GRAPSQA

AstraZeneca, United Kingdom

This session features regulatory updates from members of national, regional and global health associations sharing recent trends and changes anticipated for the future. The session will allow discussion on the evolving global regulatory environment.

Speaker(s)

Sabine  Kopp, PhD

Sabine Kopp, PhD

World Health Organization (WHO), Switzerland

Group Lead, Medicines Quality Assurance

Peter  Richardson, PhD

Peter Richardson, PhD

European Medicines Agency, Netherlands

Head of Quality, Specialised Scientific Disciplines Department

Ingo  Matthes, PhD

Ingo Matthes, PhD

Swissmedic, Swiss Agency for Therapeutic Products, Switzerland

Head of Division Quality Review/Sector Marketing Authorisation

Mihaela  Buda, PhD

Mihaela Buda, PhD

European Directorate for the Quality of Medicines & HealthCare (EDQM), France

Scientific Programme Manager, European Pharmacopoeia Department

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