The Arab Pharmacovigilance Guidelines

There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.

21-22 Oct 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

The new Arab pharmacovigilance guidelines were issued in May 2015 with their introduction on 1 July 2015. There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new 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 will be.

Who should attend

Anyone involved in pharmacovigilance and regulatory activities, including pharmacovigilance case processing; local QP PVs; 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 new PV Structure
  • The new 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 QP PV and quality management
  • Quality and training
  • QA and quality management and internal audits
The Pharmacovigilance Systems Master File (PSMF – Module II)
  • The content of the PV master le
  • Licence submissions and the PV master le
  • The QP PV and the PV master le
  • Control/management of the PV master le
Pharmacovigilance inspections (Module III)
  • The purpose of the inspection
  • Types of inspection
  • Inspection ndings
  • Re-inspections
Pharmacovigilance audits (Module IV)
  • The purpose of company audits
  • Audit scheduling and risk
  • Audit outputs and ndings
  • Audit findings and their corrections – root cause analysis, corrective action plans, completion and re-audits

Programme - Day two

Risk Management Plans (RMPs – Module V)
  • ICH E2E – pharmacovigilance planning
  • The RMP purpose
  • The RMP format
  • Updating the RMP
  • RMPs and REMs
MODULE VI – Adverse Reaction Reporting – Part 1
  • De nitions
  • 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
PSURs/Module VII
  • 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
Signals and their management (Module IX)
  • What is a signal?
  • Signal validation
  • Signal analysis and prioritisation
  • Signal assessment
    • Actions to be taken


Graeme Ladds

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.

Book now

21-22 Oct 2019
21-22 Oct 2019 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
Enrol now

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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

A wealth of experience and knowledge. Invigorating workshop and speaker

Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est

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

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

Layal Lutfi, Principal Consultant, Adamas Consulting Ltd

Very good, would recommend to PV colleagues in the industry

Emad Naguib, Global Safety Lead, Middle East , MSD

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

Good but tight

Maher Al Matar, Deputy Pharmacovigilance ,

That good

Saeed Abdullah Alqahtani, , Scientific Products Pharmaceuticals