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Best Practices for Data Supervisors in Pharmacovigilance Virtual Live Training Course

NEW OFFERING for Supervisors of Data Entry Managers and Data Quality Assurance Managers!


Faculty

  • Jan  Petracek

    Jan Petracek

    • Director
    • Institute of Pharmacovigilance, Czech Republic

    Dr. Jan Petracek has over 20 years of experience in all areas of pharmacovigilance. Between 2000-2010 he worked as a senior regulator, being former Head of Risk Management Section at EMA, Head of Pharmacovigilance and Head of Strategy and Development of the Czech NCA, and member of CHMP Pharmacovigilance Working Party. Between 2010-2020 he was CEO of multiple contract safety organisations, worked as contract EU QPPV for five MAHs, provided design of PV system and strategic advisory in relation to global PV system setups. His current main activity relates to development of International Society of Pharmacovigilance and its Special Interest Group on Career Framework for Pharmacovigilance Professionals.

  • Gro  Laier, MD

    Gro Laier, MD

    • Principal Safety Lead
    • BASE life science A/S, Denmark

    Gro Laier is currently Safety Lead at Base Life Science. She has been working within Pharmacovigilance for 25 years of these 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  Kolouch, PharmD

    Jan Kolouch, PharmD

    • Executive Director
    • NextPV Services s.r.o., Czech Republic

    Jan is an experienced PV professional with track record of successful execution as well as management of various PV activities. He currently acts as Executive Director at NextPV Services. 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. Jan has witnessed and significantly supported development and integration of medium sized PV service provider into big company, where he worked with many teams across different regions.

  • Robert  Scheiner

    Robert Scheiner

    • CIO
    • iVigee, France

    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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