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Virtual Event

2021 年 06 月 28 日 2:00 下午 - 2021 年 07 月 02 日 6:30 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS.

讲师团队

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.

Vojtech  Kvita

Vojtech Kvita

Executive Director, NextPV Services, Czech Republic

Vojtech is a qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas. The wide exposure to global clients (both sponsors and MAHs) has helped him to gain a comprehensive overview of critical PV processes and systems. Vojtech’s main expertise is advance pharmacovigilance consulting, EU QPPV activities, signal management, ICSR management, EudraVigilance support, XEVMPD/ISO IDMP, PV auditing and medical writing.

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.

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