Course overview
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
- 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 and 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)
CPD Hours: 18
Course Content
- Day 1
- Due diligence
- Training for drug safety reporting duties
- Audits and expectations
- Day 2
- Compliance and drug safety
- The PSMF
- Interactive exercise: The requirements for a safety department
- Product safety reviews - purpose and function
- Day 3
- Interactive exercise: designing the requirements for a safety review group
- Safety reporting in licensing agreements
- Developing CCSI - CIOMS III
- Day 4
- 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
- Day 5
- 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.
