Course overview
Since the introduction of new pharmacovigilance legislation in the EU in 2012 and continuing updates, Quality Management Systems (QMS) and self-audits have become increasingly critical to satisfy Regulatory expectations. Regulators now expect companies to justify and implement risk-based audits and to clearly demonstrate continual improvement of processes, systems, and regulatory compliance. This responsibility extends across the entire organisation - from senior leadership through to clinical, pharmacovigilance, sales and marketing, IT, and medical services teams.
This must-attend course clearly explains the principles, practical approaches, and regulatory expectations for pharmacovigilance QMS and risk-based audits. It has been carefully designed to support both effective risk assessment and the full Corrective and Preventive Action (CAPA) process.
The highly interactive programme combines expert-led presentations, real-life case studies, and practical workshop sessions. This dynamic format ensures participants not only understand the concepts, but also gain hands-on experience and actionable skills they can immediately apply in their roles.
CPD Hours: 12
Course Content
- Day 1
- The audit basics
- The legislation and audits
- QMS
- QMS and the audit report
- Workshop session
- Day 2
- Introduction to PV inspections
- Risk-based inspections
- The pharmacovigilance inspection cycle
- Workshop session
- Common findings from regulatory inspections
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.
