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Virtual

Nov 10, 2021 2:00 PM - Nov 12, 2021 6:00 PM

(Central Europe Standard Time)

Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)

A Virtual Live Training that will help you to gain a deep understanding of best practices in source data collection, essential role of quality checks (QC) during the whole process of report preparation, and critical aspects of medical writing, including data editing and presentation.

Faculty

Sven  Schirp

Sven Schirp

Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Sven Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and pharmacovigilance documents to global marketing applications. He is currently Head of Global Pharmacovigilance Writing at Boehringer Ingelheim.

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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