Practical Requirements of the Arab Pharmacovigilance Guidelines
On 1 July 2015, the Common Arab Guidelines on good vigilance practices became effective. The Guidelines represented fundamental changes to pharmacovigilance practice and followed many aspects of the EU guidelines of June 2012.
This intensive two-day course will look at the various topics and their practical application from the perspective of compliance with the requirements of the Regulatory Authorities. The course will include experiences of the inspections and audits following implementation and will identify what the main focus points have been for possible inspection findings.
This interactive course will help you:
- Gain an overview of the modules and the responsbilities of the Marketing Authorisation Holder (MAH)
- Discuss the practical application of the modules and documentation required
- Discover the levels of implementing Quality Management Systems (QMS) throughout the company
- Understand the regulatory expectations of inspections
- Realise what written processes need to be in place
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Reviews by course attendees
Average rating 4.8
Very talented and experienced expert who has answers to all PV queries that you can think of. Advanced training that goes through the modules of PV in depth explaining what is ...
Excellent arrangement. Would recommend a colleague to visit website to check about interesting courses.
A wealth of experience and knowledge. Invigorating workshop and speaker