The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments – not just Pharmacovigilance but also including Clinical; Medical Information; Marketing; IT; Quality; Regulatory; Training and GMP.
Running this In-house programme will help your team:
Your next step is to call us now on +44 (0)20 7729 6677 or email us at firstname.lastname@example.org or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.
Quality Management – the Requirements
Safety Reporting in the EU
Safety Reviews and Signals Detection
Risk Management Plans
Risk Benefit Analyses
PSURS/PBRERs in the EU
The Roles and Responsibilities of the MAH
Graeme Ladds, the Director of PharSafer, has over 26 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. Graeme then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.