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Virtual Event

2023 年 10 月 04 日 9:00 上午 - 2023 年 10 月 06 日 1:00 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

Virtual live hands-on training course for Clinical Trials Sponsors using EudraVigilance system

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

讲师团队

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.

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.

Isabella  Palagiano

Isabella Palagiano

, PVpharm, Spain

Isabella Palagiano graduated from Alma Mater Studiorum, University of Bologna with a master’s in Pharmacy&Pharmaceutical Industry. She is a PV professional with more than 5 years of experience on different positions across pharmacovigilance, with the main focus on ICSR Management, SPOR, EudraVigilance and XEVMPD set-up and maintenance, Deputy EU/UK QPPV activities, Local Contact Person for Pharmacovigilance, PSMF maintenance, audits/inspections and project management in post-marketing and clinical trials. From the beginning of her career, she has been involved in the maintenance of the XEVMPD and EudraVigilance operations for both Sponsors and MAHs.

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