An 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:
Please note that we are also running:
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.
To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail firstname.lastname@example.org
This course is applicable for those working in the area of product risk assessment or wanting to learn more about the USA implementation of ICH E2E risk approaches for medicines. This includes pharmacovigilance personnel working in safety review and risk assessments, QA, clinical personnel and EU QP PVs.
The background to REMS
The development of REMS
Products qualifying for REMS
Product specific REMS
The REMS audience
REMS and RMPs
Managing a REMs programme
The Impact of REMS
This course qualifies for the following CPD programmes: