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The Arab Pharmacovigilance Guidelines Training Course

Practical tips on introducing a compliant pharmacovigilance system

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 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 the introduction of the EU guidelines. The course will include experiences of inspections and audits following implementation and will identify what the main focus points have been.

This interactive course will help you:

  • Gain an overview of the modules and the responsbilities of the MAH
  • Discuss the practical application of the modules and documentation required
  • Discover the levels of implementing quality systems throughout the company
  • Understand the regulatory expectations of inspections

Who should attend

Anyone involved in pharmacovigilance and regulatory activities – 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.

Programme - Day two

An introduction to the PV structure

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

Module I – quality management systems

  • 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

Module II – 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

Module III – pharmacovigilance inspections

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

Module IV – pharmacovigilance 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

Programme - Day two

Module V – risk management plans (RMPs)

  • ICH E2E – pharmacovigilance planning
  • The RMP purpose
  • The RMP format
  • Updating the RMP
  • RMPs and 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) – DSRRs and PSURs/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

  • What is a signal?
  • Signal validation
  • Signal analysis and prioritisation
  • Signal assessment
  • Actions to be taken

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Newbridge Pharmaceuticals
  • Accord Healthcare MENA DMCC
  • Adamas Consulting Ltd
  • Al Hafez Trading Est
  • Algorithm SAL
  • American Express Global Business Travel Espana
  • Apotex Saudi Arabia
  • Arab Company for pharmaceutical products
  • Arriello s.r.o.
  • ATS Travel
  • Dar-Alzahrawi
  • Lavasta Pharma
  • Martindale pharma
  • MSD
  • Novartis Oncology
  • Research and Markets
  • Saudi Pharmaceutical Industries & Medical Appliances Corp
  • Scientific Products Pharmaceuticals
  • Valeant
  • Valeant/Baush&Lomb

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.

Shahinaz Badr, Officer, Newbridge Pharmaceuticals, Oct 18

A wealth of experience and knowledge. Invigorating workshop and speaker

Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est, Oct 18

Very good, would recommend to PV colleagues in the industry

Emad Naguib, Global Safety Lead, Middle East , MSD, Oct 17

Excellent arrangement. Would recommend a colleague to visit website to check about interesting courses.

Layal Lutfi, Principal Consultant, Adamas Consulting Ltd, Oct 17

That good

Saeed Abdullah Alqahtani, Scientific Products Pharmaceuticals, Oct 16

Speaker is an expert in the this field and he always gave examples of topics that illustrate the ideas of what he is talking about.

Soliman Alzahrani , Novartis Oncology , Oct 16

Good but tight

Maher Al Matar, Deputy Pharmacovigilance , Oct 16