Advanced Pharmacovigilance Training “Hands on Practice”

17-18 October 2018
Please note that this training is designed to target PV staff with experience in the field and to focus on practicalities for more advanced practice (i.e. not suitable for beginners as basic theoretical understanding will be assumed in the agenda regarding PSUR, PSMF & RMP) At the end of this training course you should be able to:
  • Know how to build an effective PV system within your local company
  • Understand how to structure the Pharmacovigilance and safety team
  • Appropriately handle AE and other special situations cases
  • Familiarize yourself with the principles and practice of signal detection
  • Efficiently use PBRER and RMP to optimize benefit-risk
  • Understand the regulators’ expectations regarding PV commitments
  • Plan and prepare for pharmacovigilance audits
Who should attend:
  • Pharmacovigilance officers, the especially QPPV
  • Local safety officers
  • PV regulators

The scientific committee of the training