DIA CMC Workshop

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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)

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