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Session 4A: Contract Manufacturing (Part II)
Session Chair(s)
Sabine Kopp, PhD
Group Lead, Medicines Quality Assurance
World Health Organization (WHO), Switzerland
The session should provide insights, by sharing practical experience and examples, on what can go wrong and how this can be prevented. Perspectives will be shared by speakers representing a manufacturer from a company with international hubs, a regulatory agency and a UN agency involved in international procurement.
Speaker(s)
Pharmaceutical Contract Manufacturing
Ron Ogilvie
Pfizer, United Kingdom
CMC Advisor
MRA Agreements and Contract Manufacturing
Piotr Krauze, MSc
European Medicines Agency, Netherlands
Principal Scientific Administrator, Compliance and Inspections
Aspects and Consequences for Prequalification and Major Procurement Agencies
Dimitrios Catsoulacos, PhD
World Health Organization, Switzerland
Technical Officer (Inspector)