12-13 April 2017

If you are involved in any aspect of pharmacovigilance (GPvP), our training will help you comply with Arab Guidelines and get an overview of European law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance. Your training will be given by top international and local experts. The programme content arose from collaboration with the Middle East ISoP Chapter. The scientific committee of the training: Dr. Thamir AlShammari , Dean, Pharmacy College (Saudi Arabia) Dr. Mayada Alkhakany , Head of Pharmacovigilance, Boehringer Ingelheim Dr. Brian Edwards , Principal Consultant, Pharmacovigilance & Drug Safety, NDA UK Dr. Ola Ghaleb Al Ahdab , Pharmaceutical Advisor CPD-Pharma Program Manager, Drug Department Public Health Policy & Licensing Sector, UAE MOHAP 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 PV and need for Post Authorization Safety Studies