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Virtual Event

2025 年 12 月 08 日 9:00 上午 - 2025 年 12 月 10 日 1:00 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

Virtual Live Hands-On Training Course for Clinical Trials Sponsors 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. Check the - WHO SHOULD ATTEND - section for more information regarding course pre-requisites.

讲师团队

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.

Jan  Kolouch, PHARMD

Jan Kolouch, PHARMD

CEO, Strategic PV Advisor, NextPV Services s.r.o., Czech Republic

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.

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