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DIA, Europe, Middle East, and Africa office

Jun 24, 2019 9:00 AM - Jun 26, 2019 2:00 PM

Kuechengasse 16, 4051 Basel, Switzerland

The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format

This hands-on training covers the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format.

Faculty

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.

Jose Alberto Ayala  Ortiz, MPHARM, MSC

Jose Alberto Ayala Ortiz, MPHARM, MSC

CEO, 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.

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