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Virtual

Oct 18, 2021 1:30 PM - Oct 21, 2021 5:00 PM

(Central Europe Standard Time)

Signal Management in Pharmacovigilance Virtual Live Training Course

ONLY 3 SEATS LEFT! This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.

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Faculty

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.

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.

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