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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)"

13-14 June 2024
+ 17-18 October 2024 »

from £1099

Need help?  Enrol or reserve

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.

Enrol or reserve

The Practical Requirements of the Arab Pharmacovigilance Guidelines course will cover:

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 (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

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

Module V – 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 

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 

Enrol or 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

13-14 June 2024

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 14132

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 09 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

17-18 October 2024

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 13973

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 12 Sep

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
Officer, Newbridge Pharmaceuticals

Oct 22 2018

A wealth of experience and knowledge. Invigorating workshop and speaker

Dalal Abdulaziz
Regulatory Manager, Al Hafez Trading Est

Oct 23 2017

Very good, would recommend to PV colleagues in the industry

Emad Naguib
Global Safety Lead, Middle East , MSD

Oct 23 2017

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

Layal Lutfi
Principal Consultant, Adamas Consulting Ltd

Oct 25 2016

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 25 2016

Good but tight

Maher Al Matar
Deputy Pharmacovigilance ,

Oct 25 2016

That good

Saeed Abdullah Alqahtani
Scientific Products Pharmaceuticals

United Arab Emirates

  • Newbridge Pharmaceuticals
  • A.MENARINI FARMACEUTICA INTERNAZIONALE
  • Accord Healthcare MENA DMCC
  • ARABIO
  • Lavasta Pharma
  • MSD
  • New Bridge Pharmaceuticals
  • Valeant/Baush&Lomb

Saudi Arabia

  • Apotex Saudi Arabia
  • Arab Company for pharmaceutical products
  • Dar-Alzahrawi
  • Martindale pharma
  • Novartis Oncology
  • Saudi Pharmaceutical Industries & Medical Appliances Corp
  • Scientific Products Pharmaceuticals

Spain

  • Chemo Research, S.L.
  • Ferrer Internacional
  • Grupo Ferrer International

United Kingdom

  • Adamas Consulting Ltd
  • Rosemont Pharmaceuticals

Afghanistan

  • Arabian Ranches Al Reem 3 - Villa 75

Algeria

  • Valeant

Czech Republic

  • Arriello s.r.o.

Italy

  • L.Molteni & C. dei F.lli Alitti SpA

Kuwait

  • Al Hafez Trading Est

Lebanon

  • Algorithm SAL

Enrol or reserve

Run Practical Requirements of the Arab Pharmacovigilance Guidelines Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy