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Session 3: International PV
Session Chair(s)
Shahinaz Badr, PHARMD
Founder & Managing Director, Vigilance Gate FZ,LLC, 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)
Ilaria Grisoni, MSC
Executive Director, Head of International QPPV Office, EEA QPPV, Jazz Pharmaceuticals, Italy
Management of a Local QPPV Network - a PV System that can Accommodate Local Regulation Challenges
Marylene Zhan, MBA
Senior consultant, Accestra Consulting Company, China
China GVP Update – From a QPPV Perspective
Chimwemwe Chamdimba
Principal Programme Officer-African Medicines Regulatory Harmonisation Program, African Union Development Agency-NEPAD, South Africa
Deep Dive in Africa: Harmonization of Legislation
Raphael Van Eemeren
EU QPPV Senior Director, Global Patient Safety, Amgen AB, Sweden
Eudravigilance and Data Privacy
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