In the EU, all companies are required to provide Risk Management Plans (RMPs) for every new product, whether generic products or new chemical entities, and these RMPs must also be modified and updated throughout the lifetime of a medicine. This course will provide an invaluable overview on writing and maintaining Risk Management Plans, with practical advice to ensure you achieve regulatory compliance. This course has been fully revised to include the latest updates.
By attending this course you will:
Please note that we are also running:
This meeting runs back-to-back with Producing and Maintaining the Pharmacovigilance System Master File (PSMF). Save an additional £100/€140 if you book both together.
To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail firstname.lastname@example.org
This course will be relevant for those working in pharmacovigilance who are involved with writing Risk Management Plans, including Medical Directors/QPPVs who approve such plans. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, sales and marketing, legal, commercial and quality.
09.00 Registration and Coffee
09.30 Meeting begins
An Introduction to EU RMPs – Production & Maintenance
Documentation to be Supplied to Regulatory Authorities – the process for RMPs
The EU Templates & their Completion – Generic and Innovator Products Including RMPs in other Countries
Practical – Completion of Sections I – III
Practical – Completion of Sections IV – VI
Practical – Completion of Annexes
17.00 Meeting ends
Graeme Ladds, Director of PharSafer, has over 30 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. He 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.