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April 4, 2012

EU Pharmacovigilance Change Readiness 2012

Keynote Speaker for this Event:
  • Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent   Learn More
  • EU Pharmacovigilance Change Readiness 2012

    New EU and national legislation will be changing the pharmacovigilance practice of regulators and the pharmaceutical industry in years 2012-2016. The webinar given by Dr. Jan Petracek, CEO of PharmInvent, and former Head of Risk Management Section within European Medicines Agency, will help you to:

    • Maintain inspection readiness while requirements are changing
    • Update your implementation plan for the new legislation in an environment of uncertainty
    • Understand key changes foreseen for 2012, 2013, 2014 and 2015, including game changing transparency rules, needs for IT systems, quality management systems, and benefit/risk management

    At the end of this presentation, you should be ready to:

    • Prepare your budget to run pharmacovigilance in the next few years
    • Present the updated implementation plan to your senior management
    • Remain compliant during the upcoming period of substantial changes
    • Pharmacovigilance professionals
    • Pharma companies active in the EU market
    • Pharma companies who intend to enter the EU market
    • CROs and pharmacovigilance service providers

    Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent

    Dr. Jan Petracek is a partner and CEO at PharmInvent, a contract safety and regulatory science company.

    Until August 2010, he was a Head of Risk Management Section of European Medicines Agency responsible for all operations of the Agency in relation to risk management of medicinal products. Dr. Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. He has over 12 years of experience in all areas of pharmacovigilance and regulatory affairs, being former Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, member of CHMP Pharmacovigilance Working Party, and participating in development of several national, European, ICH and CIOMS guidelines.

    Dr. Petracek's main recent activities relate to EU-QPPV services, pharmacovigilance system optimisation, and risk management of medicines.


    PharmInvent is a fast growing company which provides professional services in areas of pharmacovigilance, regulatory affairs and drug development to help pharmaceutical and biotechnology companies develop and commercialize their products. Our clients benefit from our unique expertise and insight into the European Medicines Agency, CHMP, CMDh as well as key national authorities in Europe. We provide: ·

  • Main or backup qualified person for pharmacovigilance·
  • Assistance with pharmacovigilance audits·
  • Peer-review of drafts and updates of Risk Management Plans·
  • Development of a new DDPS and peer review of existing DDPS·
  • Production of DSURs and peer review of DSURs and Annual Safety Reports·
  • Ad hoc pharmacovigilance analysis·
  • Tailored-made training for pharmacovigilance specialists·
  • Drug development strategies·
  • Scientific and registration support throughout the whole lifecycle of the medical product

  • We adapt our services and develop new ones to meet the needs of clients as conditions on the European pharmaceutical market change. PharmInvent meets SME criteria and is established in the European Union with headquarters in Prague, Czech Republic.

    For more information about PharmInvent, visit http://www.pharminvent.com/.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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