Practical Requirements of the Arab Pharmacovigilance Guidelines In-house Training

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

★★★★★ "Very talented and experienced expert who has answers to all PV queries that you can think of. Advanc... more (7)"

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Format: Bespoke training
CPD: 12 hours for your records (depending on your requirements)
Certificate of completion

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Course overview

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

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Who should attend

Anyone involved in pharmacovigilance and regulatory activities in the Middle East/Arab States – including pharmacovigilance case processing, local QPPVs, medical directors, drug safety managers, QA auditing, PSUR writers, and any company managers and licence holders wanting to know what impact this will have on their business practices.

This course will also be beneficial to companies looking to expand into this geographic area.

Reviews of IPI's Practical Requirements of the Arab Pharmacovigilance Guidelines training course

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 between the lines of the guidelines, and illustrating by real life examples.

Oct 22 2018

Shahinaz Badr United Arab Emirates
Officer, Newbridge Pharmaceuticals