THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT

Track:
Quality (including Falsified Medicines)

Day & Time:
March 5, 11:00AM - 12:30PM

Session Number:
0602

Room Number:
D203/D204

Type:
Session

Title:
THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT

Chair(s):
Jacques Morenas, PharmD
Deputy Director of the Inspection and Companies Directorate
National Agency of Medicine and Health Product Safety (ANSM),, France

Description:
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.

Presentation(s) & Speaker(s):
The Role of the Qualified Person in a Globalised Environment
Jacques Morenas, PharmD
Deputy Director of the Inspection and Companies Directorate
National Agency of Medicine and Health Product Safety (ANSM),, France

QP and Involvement in Oversight of Supplier Management
Lynne Byers
Vice President Quality
GlaxoSmithKline, United Kingdom

What does QP Oversight Really Mean
John O'Sullivan, PharmD,RPh
VP Global Qualty Strategy & Affiliate Quality Compliance
Pfizer Inc., Ireland