Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Lexington Madrid - AZCA

May 20, 2019 9:00 AM - May 22, 2019 2:00 PM

Pº Castellana, 79, 6th & 7th Floor, 28046 Madrid, Spain

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

Ana  Araujo

Ana Araujo

ADR Monitoring Unit-National Pharmacovigilance Centre, Infarmed, Portugal

Ana has worked 13 years in the Directorate of Risk Management for Medicines of the Portuguese medicines competent authority INFARMED. Until 2013, she was Responsible Person for EudraVigilance and member of the EudraVigilance Expert Working Group and EudraVigilance Telematics Implementation Group. Between 2013 and 2015, Ana was INFARMED’s Executive Board adviser responsible for managing the National Pharmacy and Therapeutic Committee. Since 2015, she has been working with consumption and prescription data on medicinal products, analysing trends in medicines’ prescription and use in Portugal. Ana has extensive experience as a trainer in pharmacovigilance and EudraVigilance since 2003.

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.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.