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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 4A: Contract Manufacturing (Part II)

Session Chair(s)

Sabine  Kopp, PHD

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

Pharmaceutical Contract Manufacturing

CMC Advisor, Pfizer, United Kingdom

Piotr  Krauze, MSC

MRA Agreements and Contract Manufacturing

Principal Scientific Administrator, Compliance and Inspections, European Medicines Agency, Netherlands

Dimitrios  Catsoulacos, PHD

Aspects and Consequences for Prequalification and Major Procurement Agencies

Technical Officer (Inspector), World Health Organization, Switzerland

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