Pharmacovigilance training

12-13 March 2018

This training workshop is intended for Qualified persons for pharmacovigilance and national PV officers who would like to improve their daily practice and better understand regulatory expectations and practical implications. The workshop is led by an expert instructor who has been a EU/EEA QPPV for 17 years and helped establish the EU QPPV Forum with which he is still involved. Together with two experts from MOHAP UAE and CAPA (Ministry of Health and Population Egypt), they aim to interactively help you better understand the daily challenges you face and hear about solutions from others in similar situations. At the end of this training course you should be able to:
  • Understand the new template and content of a Pharmacovigilance Master File as per Arab Guidelines
  • Plan and prepare for pharmacovigilance audits & inspections
  • Know the processes for safety and risk communications
  • Familiarize and know the Periodic Safety Update and Benefit/Risk Evaluation reports per the Arab Guidelines
  • Comprehend the principles of benefit risk management and monitoring effectiveness of risk minimization
  • Understand the place of epidemiology in Pharmacovigilance and need for Post Authorization Safety Studies
  • Dr.Ahmed Hegazy

    M.D., MBBCh, MSc. PharMed, Head of Global Patient Safety Intercontinental Region, Merck
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