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Virtual

Feb 18, 2025 1:00 PM - Feb 20, 2025 5:00 PM

(Central Europe Standard Time)

EudraVigilance Data Analysis System (EVDAS): Practical Approach on Use for Signal Management in the EU

This virtual live training course will teach concepts, access policy, and use of the EudraVigilance Data Analysis System (EVDAS) for signal detection.

Faculty

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.

Calin A. Lungu, MD

Calin A. Lungu, MD

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

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Representative Invited

Representative Invited

European Medicines Agency

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