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Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

15th Anniversary

Session 3: QPPV Requirements And Expectations In Non-Eu Countries

Session Chair(s)

Shahinaz Badr

Shahinaz Badr

  • Regional Pharmacovigilance Manager - Africa, Middle East and Turkey
  • Newbridge Pharmaceuticals, United Arab Emirates
Willemijn van der Spuij, MSc

Willemijn van der Spuij, MSc

  • Executive Director, WorldWide Patient Safety International, Europe
  • 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)

Willemijn van der Spuij, MSc

Presentation covering Europe (Turkey, Serbia, Switzerland)

Willemijn van der Spuij, MSc

  • Executive Director, WorldWide Patient Safety International, Europe
  • Bristol-Myers Squibb, Switzerland
Moonjung Kim, RPh

Roles and Responsibilities of Safety Control Manager in Korea

Moonjung Kim, RPh

  • Director
  • Korea Institute of Drug Safety and Risk Management, Korea, Republic of
Heather Yoo, MPharm, RPh

Overview of Local QPPV requirements in Asia Pacific

Heather Yoo, MPharm, RPh

  • Head of Patient Safety, South East Asia
  • Bristol-Myers Squibb, Singapore
Sophie Fontez

Overview of Local QPPV requirements in Asia Pacific

Sophie Fontez

  • Director, Global Clinical Safety and Pharmacovigilance (GCSP) Regions Lead (Asia
  • -Pacific), CSL Behring, Australia
Nadjat LOUMI-MEDEDJEL

Middle East and North Africa: Regulators Introduction from Algeria, Iraq, Kuwait

Nadjat LOUMI-MEDEDJEL

  • Directrice Générale
  • Centre National De Pharmacovigilance et De Matériovigilance (CNPM), Algeria
Manal Younus

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
Reem El Essa

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
Shahinaz Badr

Updates from MENA Region

Shahinaz Badr

  • Regional Pharmacovigilance Manager - Africa, Middle East and Turkey
  • Newbridge Pharmaceuticals, United Arab Emirates
Ana Paula Goncalvez

Discussion covering Latin America (Brazil)

Ana Paula Goncalvez

  • Head of Patient Safety, Brazil
  • Bristol-Myers Squibb , Brazil
Olga Ermishina, MD

Presentation covering Eurasia

Olga Ermishina, MD

  • Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU
  • Bayer, Russian Federation

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