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Session 3: QPPV Requirements And Expectations In Non-Eu Countries
Session Chair(s)
Shahinaz Badr, PharmD
Founder & Managing Director, Vigilance Gate FZ,LLC, United Arab Emirates
Willemijn van der Spuij, MSc
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, 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
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
Roles and Responsibilities of Safety Control Manager in Korea
Moonjung Kim, RPh
Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of
Overview of Local QPPV requirements in Asia Pacific
Heather Yoo, MPharm, RPh
Head of Patient Safety, South East Asia, Bristol-Myers Squibb, Singapore
Overview of Local QPPV requirements in Asia Pacific
Sophie Fontez
Director, Global Clinical Safety and Pharmacovigilance (GCSP) Regions Lead (Asia, -Pacific), CSL Behring, Australia
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Nadjat LOUMI-MEDEDJEL
Responsible for Training of Healthcare Professionals and Staff, Centre National De Pharmacovigilance et De Matériovigilance (CNPM), Algeria
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Manal Younus
Head of Iraqi Pharmacovigilance Centre, Directorate of Technical Affairs, Ministry of Health, Iraq
Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait
Reem El Essa
Senior Pharmacy Specialist and Inspector Pharmacist at Drug Inspection, Administration, Pharmacovigilance Focal Point in Kuwait Drug and Food Control, Kuwait
Updates from MENA Region
Shahinaz Badr, PharmD
Founder & Managing Director, Vigilance Gate FZ,LLC, United Arab Emirates
Discussion covering Latin America (Brazil)
Ana Paula Goncalves, MBA, MPharm, RPh
Senior Director, Patient Safety Intercontinental, Bristol-Myers Squibb , Brazil
Presentation covering Eurasia
Olga Ermishina, MD
Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU, Bayer, Russian Federation
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