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Session 8: QUALITY: THE NEVER ENDING STORY?
Session Chair(s)
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)
Results of a Bench Mark on Safety Variations
Gro Laier, MD
Denmark
PV Expert
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
Eli Lilly & Company Ltd., United Kingdom
Senior Director of Quality in Global Patient Safety
Nick Sykes, MS
EFPIA, Belgium
Policy Advisor
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