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Session 3: International PV
Session Chair(s)
Shahinaz Badr
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Pharma Quality Europe, United Arab Emirates
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV
AstraZeneca, Spain
PV regulatory requirements keep growing year after year and GVP regulations are being expanded across the globe with slightly different local flavours. What is the impact of the new local requirements for the international QPPVs and companies PV system? How can we keep up with the new extended network of local QPPVs? Africa is moving fast, will the QPPV role be impacted by the current activity of the African Medical Agency? Last but not least, data privacy is a topic of growing interest - European QPPVs have actually been approached to ensure compliance in PV activities on this regard… Do we as QPPVs know enough?
Speaker(s)
Management of a Local QPPV Network - a PV System that can Accommodate Local Regulation Challenges
Ilaria Grisoni, MSc
Gentium Srl, A Jazz Pharmaceuticals Company, Italy
Executive Director, Head of EU/International PV & Global Risk Management and EEA
China GVP Update – From a QPPV Perspective
Marylene Zhan, MBA
Accestra Consulting Company, China
Senior consultant
Deep Dive in Africa: Harmonization of Legislation
Chimwemwe Chamdimba
African Union Development Agency-NEPAD, South Africa
African Medicines Regulation Harmonization Programme Head
Eudravigilance and Data Privacy
Raphael Van Eemeren
Amgen AB, Sweden
EU QPPV Director, Global Patient Safety
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