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Radisson Blu

2018年6月20日 (水) 午前 7:45 - 2018年6月21日 (木) 午後 5:00

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 5: Regulatory Harmonisation

Session Chair(s)

Jean-Louis  Robert, PhD

Jean-Louis Robert, PhD

Former CHMP/CVMP QWP Chair

Luxembourg

This session will focus on ICH and WHO activities and will provide a candid assessment of progress to date, current challenges and future opportunities. A panel discussion will follow three presentations from global experts representing industry, regulators and WHO.

Speaker(s)

Luther  Gwaza, PhD

WHO Harmonisation Initiatives

Luther Gwaza, PhD

World Health Organization (WHO), Switzerland

Technical Officer

Jean-Louis  Robert, PhD

Regulatory Harmonisation – Progress, Challenges and Opportunities

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Ron  Ogilvie

Regulatory Landscape – Balancing Innovation, Acceleration and Global Regulatory Harmonisation

Ron Ogilvie

Pfizer, United Kingdom

CMC Advisor

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