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Radisson Blu

2018年6月20日 (水) 午前 7:45 - 2018年6月21日 (木) 午後 5:00

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

Ron Ogilvie

CMC Advisor, Pfizer, United Kingdom

Pharmaceutical Contract Manufacturing

Piotr  Krauze, MSC

Piotr Krauze, MSC

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

MRA Agreements and Contract Manufacturing

Dimitrios  Catsoulacos, PHD

Dimitrios Catsoulacos, PHD

Technical Officer (Inspector), World Health Organization, Switzerland

Aspects and Consequences for Prequalification and Major Procurement Agencies

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