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Virtual

Nov 27, 2023 9:00 AM - Nov 29, 2023 1:00 PM

(Central Europe Standard Time)

eXtended EudraVigilance Medicinal Product Dictionary training course

Virtual training course on how to submit and retrieve medicinal product data using EVWEB/ XEVMPD (Art 57 database) for authorised as well investigational medicinal products.

Faculty

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Raj  Bains

Raj Bains

Principal Consultant, Gxpconsult Limited, Germany

Raj has more than 20 years’ experience in post-authorisation and clinical trial pharmacovigilance. Since 2005, she is trainer for Eudravigilance and the Eudravigilance Product Dictionary courses. Raj is consultant member on the editorial board of the Regulatory Rapporteur Journal. She is a BSI qualified lead auditor for ISO 9001, a member of the Oxford Research Ethics Committee and the UK’s Health Research Authority Phase I Advisory Panel. She has a background in biochemistry and toxicology. Raj works as a consultant.

Monika  Gappa

Monika Gappa

Pharmacovigilance Officer, PVpharm, Spain

Monika Gappa is a Pharmacovigilance professional with a degree in Pharmacy from Medical University in Gdansk, Poland. She has 4 years of expertise in PV with a wide background in the fields of XEVMPD and EudraVigilance set-up and maintenance. Additionally, she has managed local, global and regulatory intelligence projects as well as supported Health Authority inspections and client audits. Since 2020, she is the PV Network Coordinator of Local Contact Persons for Pharmacovigilance for more than 25 countries. It is the broad range of experiences that gives Monika a different perspective on the industry she works in.

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