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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Post-Market Surveillance & Pharmacovigilance Learning Path
4.7
★★★★★
97% Recommended
Updated 2025
23 hours
0 active users
23 points
If you'd like to swap a course or add additional courses, simply let us know — Reach out to us and we’ll customize a learning path tailored to your training needs.
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Each course includes:
Fully compliant
This learning path is aligned with EU GVP Modules, EMA and FDA post-marketing safety reporting requirements, ICH E2 series guidelines, and GVP audit standards — providing comprehensive coverage of the regulatory and operational pharmacovigilance framework for approved products. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam does not mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The Post-Market Surveillance & Pharmacovigilance Learning Path is designed to provide professionals with end-to-end competency in the regulatory obligations, operational processes, and strategic oversight activities required for post-approval drug and device safety surveillance. Covering the full GVP module framework, ICSR case handling, signal detection, literature monitoring, PSUR and PBRER management, real-world evidence, PV audit, device vigilance, and AI applications in pharmacovigilance, this programme equips professionals to manage the complete safety lifecycle of approved pharmaceutical and medical device products.
Participants will develop a thorough understanding of the regulatory reporting timelines, benefit-risk assessment frameworks, post-approval study requirements, and audit readiness practices that underpin a compliant and effective pharmacovigilance system — as well as the emerging role of AI in transforming post-market safety operations.
How this differs from the Pharmacovigilance & Drug Safety Learning Path
The Post-Market Surveillance & Pharmacovigilance Learning Path takes a strategic and regulatory oversight perspective — covering the full PV system from GVP foundations through signal management, PSUR/PBRER reporting, RWE and non-interventional studies, PV audit, and device vigilance. It is designed for professionals who need broad regulatory and compliance knowledge across the post-market safety landscape.
In comparison, the Pharmacovigilance & Drug Safety Learning Path focuses more narrowly on operational day-to-day PV activities — case handling, literature screening, PSUR management, and AI tools. This broader post-market learning path is best suited to QPPV nominees, PV managers, regulatory affairs specialists, and audit professionals seeking comprehensive oversight competency across the product post-approval lifecycle.
Courses Included
Foundations of pharmacovigilance — GVP modules, MAH obligations, QPPV role, PV systems, and regulatory reporting timelines
3 hours
2 points
End-to-end ICSR management — case receipt, triage, medical coding, narrative writing, and regulatory submission timelines
2 hours3 points
Systematic literature monitoring as a GVP Module VI obligation — search strategies, triage, case identification, and ongoing surveillance
2 hours3 points
PSUR preparation, content requirements, EURD timelines, and submission to EMA and national competent authorities
2 hours3 pointsPBRER structure, benefit-risk evaluation methodology, integrated safety summary, and ICH E2C(R2) alignment
2 hours3 points
AI applications in case processing, signal detection, and literature screening — regulatory considerations and forward-looking competencies for PV professionals
2 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Qualified Persons for Pharmacovigilance (QPPVs) and deputy QPPVs
- Pharmacovigilance managers and safety surveillance leads
- Regulatory affairs professionals responsible for post-approval commitments
- PV auditors and quality assurance professionals in MAH organisations
- Medical affairs and clinical safety teams in pharmaceutical companies
- CRO professionals supporting post-market PV activities
- Medical device post-market surveillance and regulatory specialists
- Life sciences professionals seeking comprehensive post-approval safety competency
Upon completion of this learning path, participants will be able to manage compliant post-market pharmacovigilance operations including ICSR case handling, signal detection and risk assessment, literature monitoring, PSUR and PBRER preparation, non-interventional study oversight, PV system auditing, and medical device vigilance — in alignment with EU GVP modules, ICH E2 series guidelines, and global regulatory expectations for post-approval safety surveillance.
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