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2019 年 10 月 14 日 8:00 上午 - 2019 年 10 月 15 日 5:00 下午

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Session 2: Arab League GVP Inspection

Session Chair(s)

Dana  Isleem

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)

Amal  Arafah, MPH

SFDA Inspections – Regulators’ Perspective

Amal Arafah, MPH

Saudi Food and Drug Authority, Saudi Arabia

Medication Safety Specialist

Marouane  El Kabaili, PharmD

Arab League GVP Inspection Pharma Perspectives

Marouane El Kabaili, PharmD

Pfizer, Morocco

arab League QPPV & Cluster Safety Lead North West Africa and Middle East

Dana  Isleem

Arab League GVP Inspection Pharma Perspectives

Dana Isleem

Bristol-Myers Squibb , Saudi Arabia

Pharmacovigilance Manager

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