Course overview
Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. There are many requirements and duties for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non-compliance can be severe.
EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance, and this invaluable one-day course will help you meet that requirement with a concise overview of the pharmacovigilance function and current regulatory requirements.
CPD Hours: 6
Course Content
- Day 1
- An introduction to EU pharmacovigilance
- Documentation to be supplied to regulatory authorities
- Department links in the company to pharmacovigilance
- The roles and responsibilities of a licence holder
- The role of the QPPV
- SOPs in relation to pharmacovigilance
- Pharmacovigilance 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.
