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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)
Ron Ogilvie
CMC Advisor, Pfizer, United Kingdom
Pharmaceutical Contract Manufacturing
Piotr Krauze, MSC
Principal Scientific Administrator, Compliance and Inspections, European Medicines Agency, Netherlands
MRA Agreements and Contract Manufacturing
Dimitrios Catsoulacos, PHD
Technical Officer (Inspector), World Health Organization, Switzerland
Aspects and Consequences for Prequalification and Major Procurement Agencies