Advanced Pharmacovigilance: From Performing Successful Due Diligence To Benefit-Risk Assessments - What To Consider (Mar 1St - Mar 3Rd, 2027)
Dublin, Aug. 18, 2026 (GLOBE NEWSWIRE) -- The "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.
Advanced Pharmacovigilance Compliance and Drug Safety Reporting Course
Rapid regulatory change has increased the complexity of pharmacovigilance, drug safety reporting and risk management for pharmaceutical organisations operating across global markets. This advanced pharmacovigilance course provides a practical and comprehensive review of the principal regulatory requirements, systems and processes needed to support compliant safety operations.
Designed for professionals with at least two years of drug safety or pharmacovigilance experience, the course examines the operational and strategic responsibilities involved in maintaining an effective pharmacovigilance system. Participants will explore current regulatory expectations and consider how established requirements influence safety surveillance, compliance monitoring, signal analysis, aggregate reporting and benefit-risk evaluation.
The programme places particular emphasis on pharmacovigilance audits and risk-based inspections. It reviews the expectations placed on marketing authorisation holders and examines the controls required to demonstrate compliance. Participants will consider how inspection readiness, governance, documentation and oversight contribute to a robust drug safety framework.
The course also provides an overview of the EU Pharmacovigilance System Master File (PSMF), including its role within an organisation's wider compliance structure. Product safety reviews are addressed in detail, with consideration given to their purpose, function and relationship to the latest EU signal analysis requirements.
Safety reporting obligations within licensing agreements form another important area of the programme. Participants will assess the provisions needed to establish clear responsibilities between commercial partners and support the timely exchange, assessment and submission of safety information. The development and maintenance of company core safety information (CCSI), in accordance with CIOMS III, will also be examined.
Aggregate safety reporting requirements are covered through a focused review of Periodic Safety Update Reports (PSURs), including reporting schedules, required content and applicable regulatory expectations. The programme also considers Development Safety Update Reports (DSURs) and the latest requirements associated with the second revision of ICH E2C.
For organisations conducting multinational studies, the course explores the implications of pharmacovigilance requirements for safety reporting in global clinical trials. This includes the coordination of safety information across territories, the management of regulatory timelines and the challenges created by differing national and regional obligations.
Benefit-risk determinations and risk management plans (RMPs) complete the programme, enabling participants to evaluate how safety evidence supports regulatory decision-making throughout the product lifecycle. By connecting regulatory principles with practical implementation, the course helps experienced professionals strengthen pharmacovigilance compliance and improve the quality, consistency and oversight of drug safety reporting.
Key topics include:
- Pharmacovigilance audits, regulatory expectations and risk-based inspections Drug safety compliance, governance and inspection readiness EU Pharmacovigilance System Master File requirements Product safety reviews and current EU signal analysis requirements Safety reporting provisions in licensing and partnership agreements Development of company core safety information under CIOMS III PSUR timing, content and submission requirements DSUR requirements and the second revision of ICH E2C Safety reporting considerations for global clinical trials Benefit-risk evaluation and regulatory decision-making Development and maintenance of risk management plans
This advanced training is suitable for pharmacovigilance specialists, drug safety professionals, regulatory affairs personnel, clinical safety teams, medical reviewers, quality assurance professionals and managers responsible for safety compliance. It is particularly relevant for those seeking to update their knowledge of EU and international pharmacovigilance requirements while developing practical approaches to regulatory reporting and risk management.
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.
Key Topics Covered:
- Day 1
- Due diligence Training for drug safety reporting duties Audits and expectations Compliance and drug safety The PSMF Interactive exercise: The requirements for a safety department Product safety reviews - purpose and function Interactive exercise: designing the requirements for a safety review group Safety reporting in licensing agreements Developing CCSI - CIOMS III Interactive exercise: should new safety data from a clinical trial be put into core safety information? PSURs and the revisions in ICH E2C The EU Clinical Trials Directive Risk-benefit determinations Risk-benefit determinations Interactive exercise: reviewing the safety and risk-benefit of a product RMPs Crisis management within drug safety Interactive exercise: deciding how to handle a major crisis within the company
Speakers
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.
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