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RAI Center

Mar 04, 2013 9:00 AM - Mar 06, 2013 5:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

25th Annual EuroMeeting

THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT

Session Chair(s)

Jacques  Morenas, PharmD

Jacques Morenas, PharmD

Deputy Director of the Inspection and Companies Directorate

National Agency of Medicine and Health Product Safety (ANSM), France

The EU pharmaceutical legislation puts a lot of responsibilities on the QP’s shoulders. The session will examine new challenges of the QP implied by the Falsified Medicines Directive and explain the role of the QP in daily practice, including the current revision of Annex 16 to the GMP Guide. In addition, it will summarise the QP’s involvement in the oversight of supplier management.

Speaker(s)

Jacques  Morenas, PharmD

The Role of the Qualified Person in a Globalised Environment

Jacques Morenas, PharmD

National Agency of Medicine and Health Product Safety (ANSM), France

Deputy Director of the Inspection and Companies Directorate

Lynne  Byers

QP and Involvement in Oversight of Supplier Management

Lynne Byers

GlaxoSmithKline, United Kingdom

Vice President Quality

John  O'Sullivan, PharmD, RPh

What does QP Oversight Really Mean

John O'Sullivan, PharmD, RPh

Pfizer Inc., Ireland

VP Global Qualty Strategy & Affiliate Quality Compliance

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