06 Jul 2018
Reference No: M1803276 - MAFApply for this event
The course will provide insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS. The course will also briefly look at the approaches between the EU and USA for the same product under an RMP or REMs programme.
Topics to be covered will include:
6 July 2018
81 Jermyn St,
*This meeting runs back-to-back with Writing Risk Management Plans (RMPs) on 4 July 2018 and also Producing and Maintaining the Pharmacovigilance System Master File (PSMF) on 5 July 2018. There is a further £100/€140 discount off each course when booked together.
GBP & EUR Prices exclude VAT