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Regulations and Enforcement Impacting Medicine Manufacturing and Supply in a Globalised Context
Session Chair(s)
Stephan Roenninger, DrSc
Director, Quality External Affairs
Amgen (Europe) GmbH, Switzerland
Facilitating public health by freeing inspection resources for industry and national competent authorities, and ensuring high quality medicines for patients in an environment of trade negotiations.
Speaker(s)
The ÈMA/HMA guidance on product availability and drug shortages
Andrei Spinei, MPharm, MSc
European Medicines Agency, Netherlands
Scientific Administrator
AFMPS: Medicines shortages from a member’s perspective
Laure Geslin
Federal Agency for Medicines and Health Products, Belgium
Head of Proper Use Division
Panelist
Joey Gouws, PhD, MPharm
World Health Organization, South Africa
Director, Inspectorate & Law Enforcement, South African Department of Health
Manufacturing Aspects on drug shortage prevention in a global context
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
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