Speaker Profile


Dr. Michael Forstner

Head of Pharmacovigilance Europe, Boehringer Ingelheim

Michal Forstner-Dambenois has 17 years experience in the pharmaceutical industry in R&D and Drug Safety, most recently heading the European PV department of a large international pharmaceutical company with the responsibility to establish and maintain a compliant and high-performance PV system in all EU and non-EU countries, including Russia/CIS and Israel. Led the introduction of integrated risk management planning and the new EU-RMP process in a global PV organization, including development of RMP implementation processes and methods for the evaluation of effectiveness of risk minimization. Vast experience in the application of risk and benefit-risk analysis methodologies on pharmaceutical products and processes. Subject matter expert in drug safety issue and crisis management. Experience in auditing/QC monitoring of PV systems at the global, regional and local level, as well as experience as host and/or SME in regulatory authority inspections.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • $189.00
Drug Safety Risk Management Planning

Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.

  • Recorded
  • View Anytime
  • $146.00
Drug Safety Risk Management Planning

Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.

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