Course overview
Increasingly, the most common critical findings in regulatory inspections relate to signal detection and signal management. As regulatory expectations continue to rise, the ability to identify potential safety signals and risks in patients has never been more important. Protecting patients through robust, structured, and compliant methodologies now requires companies to ensure their teams are highly trained, confident, and competent in these essential activities.
This comprehensive course delivers a detailed, practical overview of all key aspects of safety reviews and signal detection within a company. It covers signal evaluation for both innovator and generic products, in line with the updated Module IX (and addendum) signal management requirements, including the critical links to Risk Management Plans (RMPs) / Risk Evaluation and Mitigation Strategies (REMS). The course also addresses benefit-risk determinations and quantitative signal assessments, providing participants with the knowledge needed to meet regulatory expectations with confidence.
To ensure practical understanding and real-world application, examples and interactive exercises are included throughout the course, enabling delegates to strengthen their skills and apply learning directly to their day-to-day roles.
CPD Hours: 12
Course Content
- Day 1
- An introduction to safety signals
- Causality and signal detection
- The safety review meeting and process
- Safety assessments life cycle
- The regulatory requirements for signal detection - Module IX
- The signal review cycle
- Day 2
- Qualitative signal detections
- Signals and their discussion
- Safety communication
- Quantitative signal analysis
- EVDAS and the EU
- Risk-benefit analysis
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.
