Practical Requirements of the Arab Pharmacovigilance Guidelines In-house Training ★★★★★

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

In-house

Tailored to your team's requirements, at your choice of location or online.

From

£1,000

Per delegate, based on 10 delegates and a duration of 2 days

Contact our in-house team

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Course overview

On 1 July 2015, the Common Arab Guidelines on Good Vigilance Practices came into effect, marking a significant transformation in pharmacovigilance across the region. Closely aligned with key aspects of the June 2012 EU guidelines, these regulations introduced a new era of standards, expectations, and regulatory oversight.

This intensive two-day course brings these guidelines to life, exploring each topic through a practical, real-world lens. Designed with a strong focus on compliance with Regulatory Authority requirements, the programme goes beyond theory to examine how the guidelines are applied in practice. Participants will gain valuable insights drawn from inspection and audit experiences following implementation, with a clear focus on the areas most frequently highlighted in inspection findings.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Gain a clear overview of the modules and the responsibilities of the Marketing Authorisation Holder (MAH)
Explore the practical application of the modules and the required documentation
Discover how to implement Quality Management Systems (QMS) across the company
Understand regulatory expectations during inspections
Identify the written processes that need to be in place

Who should attend

This course is designed for professionals involved in pharmacovigilance and regulatory activities across the Middle East and Arab States. It is also valuable for organisations looking to expand into this region.

Relevant roles include:

Pharmacovigilance case processing specialists
Local QPPVs
Medical directors
Drug safety managers
QA auditors
PSUR writers
Company managers
Licence holders

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