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 of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. The programme 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 email@example.com
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.
An introduction to EU RMPs – production and maintenance
Documentation to be supplied to regulatory authorities – the process for RMPs
The EU templates and 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, section VII
|27 Jan 2020|
|27 Jan 2020||Venue not yet confirmed||GBP 699.00
+ VAT @ 20.00%