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Session 3: QPPV Requirements And Expectations In Non-Eu Countries
Session Chair(s)
Shahinaz Badr
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Pharma Quality Europe, United Arab Emirates
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
Over the years global development of QPPV requirements have been implemented. We will address multiple regions and countries to identify the different local requirements implemented and how does this affect the PV system. Differences and similarities of the requirements and responsibilities for non-EU QPPV and EU QPPV will be explored including high level consideration of:
- how this will influence or impact the EU QPPV
- Opportunities and Challenges in the oversight
Leading to session 4: You by now well informed on the requirements so let us explore how can we implement those requirements in the PV system through session 4.
Speaker(s)
Presentation covering Europe (Turkey, Serbia, Switzerland)
Willemijn van der Spuij, MSc
Switzerland
Executive Director, WorldWide Patient Safety International, Europe
Roles and Responsibilities of Safety Control Manager in Korea
Moonjung Kim, RPh
Korea Institute of Drug Safety and Risk Management, Korea, Republic of
Director
Overview of Local QPPV requirements in Asia Pacific
Heather Yoo, MPharm, RPh
Bristol-Myers Squibb, Singapore
Head of Patient Safety, South East Asia
Overview of Local QPPV requirements in Asia Pacific
Sophie Fontez
-Pacific), CSL Behring, Australia
Director, Global Clinical Safety and Pharmacovigilance (GCSP) Regions Lead (Asia
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Nadjat LOUMI-MEDEDJEL
Centre National De Pharmacovigilance et De Matériovigilance (CNPM), Algeria
Directrice Générale
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Manal Younus
Ministry of Health, Iraq
Head of Iraqi Pharmacovigilance Centre, Directorate of Technical Affairs
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Reem El Essa
Administration, Pharmacovigilance Focal Point in Kuwait Drug and Food Control, Kuwait
Senior Pharmacy Specialist and Inspector Pharmacist at Drug Inspection
Updates from MENA Region
Shahinaz Badr
Pharma Quality Europe, United Arab Emirates
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Discussion covering Latin America (Brazil)
Ana Paula Goncalvez
Bristol-Myers Squibb , Brazil
Head of Patient Safety, Brazil
Presentation covering Eurasia
Olga Ermishina, MD
Bayer, Russian Federation
Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU
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