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 responsibilities 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.
Agenda:
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
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)
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