# Advanced Pharmacovigilance: Due Diligence to Benefit-Risk Assessments (3-Day Online Training Course: Mar 1-3, 2027) | Regulatory Complexity Drives Drug Safety and Compliance Investment
- Published: 2026-11-13
- Author: [Healthcare News](https://healthcarenews.io/author/healthcarenews-io.md)
- Topics: [News](https://healthcarenews.io/news.md)
- Source: https://healthcarenews.io/news/advanced-pharmacovigilance-due-diligence-to-benefit-risk-assessments-3-day-online-training/
- Publication: Healthcare News
- Publisher: Connectively (Terkel, Inc.)
- Editorial policy: https://healthcarenews.io/editorial-policy/
Dublin, Nov. 13, 2026 [(GLOBE NEWSWIRE)](https://www.globenewswire.com) -- "Advanced Pharmacovigilance: From Performing Successful Due Diligence to Benefit-Risk Assessments - What to Consider (Mar 1st - Mar 3rd, 2027)" has been added to **ResearchAndMarkets.com's** offering.
Pharmacovigilance has undergone significant regulatory change in recent years, creating increasingly complex safety surveillance, risk assessment and reporting requirements for pharmaceutical organizations. Maintaining compliance requires experienced professionals to understand evolving global regulations, inspection expectations and the practical application of robust drug safety systems.
This advanced pharmacovigilance course provides a comprehensive and practical examination of the principal regulatory requirements affecting drug safety and risk management. It is designed for professionals with at least two years' knowledge or experience in drug safety who want to strengthen their understanding of compliant safety reporting, regulatory inspections and global pharmacovigilance activities.
Participants will explore how regulatory requirements influence pharmacovigilance operations across the product lifecycle. The course addresses the systems, documentation and processes required to support effective compliance while helping organizations prepare for audits and risk-based inspections. It also examines the role of product safety reviews, signal analysis and risk-benefit determinations in maintaining an effective pharmacovigilance framework.
**Key pharmacovigilance topics include:**
- Audits and expectations - risk-based inspections
- Compliance and drug safety
- Overview of the PSMF in the EU
- Product safety reviews - purpose and function, incorporating the latest EU signal analysis requirements
- Safety reporting in licensing agreements
- Developing company core safety information (CCSI) - CIOMS III
- PSURs - timing, content, the DSUR and the latest ICH E2C 2nd revision requirements
- Implications for safety reporting in global clinical trials
- Risk-benefit determinations
- Risk management plans (RMPs)
The course considers audit readiness and the expectations associated with contemporary regulatory inspections. Participants will assess how a risk-based inspection approach can affect pharmacovigilance priorities, internal controls, documentation and evidence of compliance. Coverage of the PSMF in the EU will support a clearer understanding of its relevance to the oversight and maintenance of pharmacovigilance systems.
Product safety reviews are examined in the context of their purpose, function and contribution to ongoing signal management. Particular attention is given to the latest EU signal analysis requirements and their implications for safety evaluation. The course also reviews the development of company core safety information (CCSI) - CIOMS III, alongside the management of safety reporting obligations established through licensing agreements.
Participants will examine the timing and content requirements for PSURs, the DSUR and the latest ICH E2C 2nd revision requirements. This content is complemented by consideration of safety reporting in global clinical trials, where organizations must manage multiple regulatory expectations and maintain consistent oversight across jurisdictions.
Risk-benefit determinations and risk management plans (RMPs) form an important part of the programme. These sessions focus on the regulatory and operational considerations involved in evaluating product safety, documenting conclusions and maintaining appropriate risk management measures.
By completing the course, attendees will enhance their ability to evaluate pharmacovigilance compliance requirements, support inspection preparedness and contribute to effective safety reporting processes. The practical emphasis makes the programme relevant to experienced drug safety professionals, pharmacovigilance personnel, regulatory affairs specialists, clinical safety teams and others responsible for maintaining compliant safety systems.
**CPD Hours:** 18
**Who should attend?**
This course would be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.
**Speaker**
**Graeme Ladds**
Graeme Ladds, Director of PharSafer, has over 30 years' experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
For more information about this training visit https://www.researchandmarkets.com/r/pcrqs
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