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Virtual

Jun 20, 2022 1:00 PM - Jun 22, 2022 5:00 PM

(Central Europe Standard Time)

Best Practices for Data Supervisors in Pharmacovigilance

This new virtual live training course is designed to look at the heart of the "big data" challenge and help those in charge to set up a system that uses the best practices in PV available today to battle grey zones and to get the most from your data.

Faculty

Gro  Laier, MD

Gro Laier, MD

PV Expert, Denmark

Gro Laier has been working within Pharmacovigilance for more than 25 years of these 1 year at Base Life Science, 4 years at Leo Pharma, 16 at Novo Nordisk, two at The Danish Medicines Agency and two at H Lundbeck. She graduated as a physician from University of Copenhagen in 1987. After a few months employment as a Register at a hospital in Copenhagen, she worked for 7 years within toxicology, before she took a position at the Danish Medicines Agency and started a long career within Pharmacovigilance.

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.

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.

Robert  Scheiner, MSc

Robert Scheiner, MSc

CIO, iVigee, United States

Mr Scheiner started his career lecturing Database Design and Database Management at the University of Technology, Sydney (1997-2000). Since then stayed in ICT technical and leadership roles in private sector and EU regulatory agencies, including EMA where he led the technical development of EudraGMP, EUTCT, EU Clinical Trials, ISO-IDMP and others. He has always focused on implementing complex data pipelines starting from data collection (mostly EU-wide), evaluation, processing, analytics as well as learning from the data. Currently an IT Lead at the European Banking Authority in Paris, and future CIO (as of 1/11/2021) of iVigee.

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