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 intensive one-day course will provide you with an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. You will discuss best practice for using the EU templates and risk minimisation tools to enhance the benefit/risk of your product.
The programme has been fully revised to include the latest updates.
Benefits of attending:
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 RMPs, 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.
Introduction, welcome and objectives
An introduction to RMPs
Outline of EU RMPs
The EU templates and their completion – generic and innovator products
Completion of RMPs in other countries
The EU RMP and relationship with other documents
Overview of the sections of the EU RMP template
Overview of the sections of the EU RMP template (continued)
Final discussion session
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.
|27 Jan 2020|
|27 Jan 2020||Cavendish Hotel, London||GBP 699.00
+ VAT @ 20.00%
Until 20 Dec*
|29 Jun 2020|
|29 Jun 2020||Rembrandt Hotel, London||GBP 699.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code