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Millennium Gloucester Hotel London Kensington

May 14, 2014 9:00 AM - May 15, 2014 5:30 PM

4-18 Harrington Gardens, London, SW7 4LH, United Kingdom

8th European Forum for Qualified Person for Pharmacovigilance (QPPV) and Pre-conference Workshop

Session 8: QUALITY: THE NEVER ENDING STORY?

Session Chair(s)

Brian  Edwards, DrMed

Brian Edwards, DrMed

Vice President

International Society of Pharmacovigilance, United Kingdom

President Harry Truman once said “The buck stops here”'. And so it is with the EU QPPV who shall have sufficient authority to influence the performance of PV activities and the quality systems and to promote, maintain and improve compliance with the legal requirements of the MAH. What do we understand by ‘quality systems’ let alone how can we ‘influence’ and’ improve’ them? In this session we will examine latest thinking, best practices, the scope for interactions with QA organisations and give practical guidance for QPPVs to implement when they return back to their companies.

Speaker(s)

Gro  Laier, MD

Results of a Bench Mark on Safety Variations

Gro Laier, MD

Denmark

PV Expert

Pam  Bones, PhD

Two views to Complying with Module 1 - QA view (outside looking in)

Pam Bones, PhD

Allergan, Inc., United Kingdom

Head, Global Regulatory Quality-PV

Noha  Kassem, PhD

Noha Kassem, PhD

Eli Lilly & Company Ltd., United Kingdom

Senior Director of Quality in Global Patient Safety

Nick  Sykes, MS

Nick Sykes, MS

EFPIA, Belgium

Policy Advisor

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