Arab Pharmacovigilance Guideline Practical Requirements Training Course (ONLINE EVENT: June 13-14, 2024)

News provided by

Feb 09, 2024, 05:30 ET

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Practical Requirements of the Arab Pharmacovigilance Guidelines Training Course" conference has been added to ResearchAndMarkets.com's offering.

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.

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.

This interactive course will help you:

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

Certification:

CPD: 12 hours for your records
Certificate of completion

Agenda:

Day 1

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
License 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

Day 2

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/periodic 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

Speakers:

Graeme Ladds
Director
PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.

For more information about this conference visit https://www.researchandmarkets.com/r/ppeoqo

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg

SOURCE Research and Markets