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:
- Evaluate the place of the QPPV in the Pharmacovigilance System of a Company
- Share experiences from the EU QPPV to learn better how to fulfil and deal with the role of the QPPV
- Understand the challenges of being a QPPV for Small & Medium Enterprises and contractually within CROs
- Advance understanding of the legal and liability aspects for the QPPV and what documents need to be in place
- Enable QPPVs to articulate their role in the company in order to promote senior management understanding and support
- Design initiatives to move the QPPV position forward successfully in Middle East
Who Will Attend?
- PV professionals including PV and local safety officers
- Qualified Persons for Pharmacovigilance
- Deputy Qualified Persons for Pharmacovigilance
- Pharmacovigilance Regulators & Inspectors
- CRO & Consultants providing QPPV Services