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Session 2: Arab League GVP Inspection
Session Chair(s)
Dana Isleem
Pharmacovigilance Manager
Bristol-Myers Squibb , Saudi Arabia
Achieving a successful outcome in an audit or inspection is a formal objective for many leaders. But what does ‘success’ look like? The Pharmacovigilance inspections are designed to determine compliance with regulatory pharmacovigilance obligations and in this session We will share some practises on the planning and conduct of the pharmacovigilance Inspection of the different parties involved to focus on some particular areas of concern and bring some thought-provoking ideas to the table for discussion.
Speaker(s)
SFDA Inspections – Regulators’ Perspective
Amal Arafah, MPH
Saudi Food and Drug Authority, Saudi Arabia
Medication Safety Specialist
Arab League GVP Inspection Pharma Perspectives
Marouane El Kabaili, PharmD
Pfizer, Morocco
arab League QPPV & Cluster Safety Lead North West Africa and Middle East
Arab League GVP Inspection Pharma Perspectives
Dana Isleem
Bristol-Myers Squibb , Saudi Arabia
Pharmacovigilance Manager
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