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Mercure Paris La Défense Grande Arche

Nov 15, 2017 12:30 PM - Nov 16, 2017 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre (Paris region), France

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

ONLY 1 SEAT LEFT! This course introduces essential aspects of medical writing of aggregate safety reports in the context of current legal framework in the EU and globally.

Faculty

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, Ivigee, Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Zuzana  Vinterova, PhD

Zuzana Vinterova, PhD

Strategic Advisor, Medical Writing, PrimeVigilance s.r.o., Czech Republic

Zuzana Vinterova received her PhD in Biochemistry from Charles University in Prague and she worked as a researcher at the Institute of Organic Chemistry and Biochemistry within the Czech Academy of Sciences, focusing on the major virulence factors of pathogenic yeasts (Candida spp.). Zuzana has joined PharmInvent (rebranded to PrimeVigilance in 2018) as a scientific specialist and medical writer and has now over 10 years of experience in medical writing of pharmacovigilance (PSUR/PBRER, DSUR, ACO, RMP) as well as regulatory science documents, needed throughout the full life-cycle of medicinal products.

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