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Practical Requirements of the Arab Pharmacovigilance Guidelines Training Course

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)"

10-11 February 2025
+ 12-13 June 2025, 16-17 October 2025 »
from £1299

Need help? Enrol/reserve

Format: Live online
CPD: 12 hours for your records
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 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.

Benefits of attending

Gain an overview of the modules and the responsibilities 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

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.

Enrol/reserve

This course will cover:

Day 1
Day 2

An introduction to the PV structure

Overview of the modules
The interaction of the modules
A comparison to the EU modules

Quality management systems (QMS)

Quality control, quality assurance and quality management
Quality management of PV systems
The QPPV and quality management
Quality and training
QA and quality management and internal audits

The Pharmacovigilance System Master File (PSMF)

The content of the PSMF
Licence submissions and the PSMF
The QPPV and the PSMF
Control/management of the PSMF

Pharmacovigilance inspections

The purpose of the inspection
Types of inspection
Inspection findings
Re-inspections

Ppharmacovigilance audits

The purpose of company audits
Audit scheduling and risk
Audit outputs and findings
Audit findings and their corrections – root cause analysis, corrective action plans, completion and re-audits

Risk Management Plans (RMPs) and risk minimisation

ICH E2E – pharmacovigilance planning
The RMP purpose
The RMP format
Updating the RMP
RMPs and risk evaluation & mitigation strategies (REMs)

Module VI – adverse reaction reporting (part 1)

Definitions
Special situations
Triage – seriousness
Expectedness and causality
Expedited reporting

Module VI – adverse reaction reporting (part 2)

Electronic ADR reporting – local and international
Follow-up of cases
ICH E2D – post-marketing safety
Literature ADR reporting
Case closure

Module VII – periodic safety update reports (PSURs)

ICH E2F and ICH E2C (R2) – development safety update reports (DSURs) and PSURs/perdiodic benefit risk evaluation reports (PBRERs)
Objectives of the PSURs
Risk benefit analyses in PSURs
The format of the PSUR
Mapping signals and risks to the PSUR

Module IX – signals and their management and safety communication

What is a signal?
Signal validation
Signal analysis and prioritisation
Signal assessment
Actions to be taken - safety communication

Adverse reaction reporting (part 1)

Definitions
Special situations
Triage – seriousness
Expectedness and causality
Expedited reporting

Adverse reaction reporting (part 2)

Electronic ADR reporting – local and international
Follow-up of cases
ICH E2D – post-marketing safety
Literature ADR reporting
Case closure

Periodic Safety Update Reports (PSURs)

ICH E2F and ICH E2C (R2) – development safety update reports (DSURs) and PSURs/perdiodic benefit risk evaluation reports (PBRERs)
Objectives of the PSURs
Risk benefit analyses in PSURs
The format of the PSUR
Mapping signals and risks to the PSUR

Signals and their management and safety communication

What is a signal?
Signal validation
Signal analysis and prioritisation
Signal assessment
Actions to be taken - safety communication

Enrol/reserve

Graeme Ladds
PharSafer Associates Ltd

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

10-11 February 2025

Live online

08:00-15:30 UK (London) (UTC+00)
09:00-16:30 Paris (UTC+01)
03:00-10:30 New York (UTC-05)
Course code 14500

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 06 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

12-13 June 2025

Live online

08:00-15:30 UK (London) (UTC+01)
09:00-16:30 Paris (UTC+02)
03:00-10:30 New York (UTC-04)
Course code 14749

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 08 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

16-17 October 2025

Live online

08:00-15:30 UK (London) (UTC+01)
09:00-16:30 Paris (UTC+02)
03:00-10:30 New York (UTC-04)
Course code 15019

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 11 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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