DUBLIN--(BUSINESS WIRE)--The "An Introduction to Risk Evaluation & Mitigation Strategies (REMS)" conference has been added to Research and Markets' offering.
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 include:
- The background to REMS
- What products qualify for REMS?
- Understand the different categories of REMS
- Discuss their introduction, maintenance and reporting assessments
- Contrast the approach between the US and FDA for a RMP or REMS programme
Who Should Attend:
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, including pharmacovigilance personnel working in safety review and risk assessments; QA; Clinical personnel; EU QP PVs;
Agenda:
The background to REMS
- ICH E2E
- PDUFA III
- REMS history
The development of REMS
- Products qualifying for REMS
- Product specific REMS
The REMS audience
- Identifying the need for a REMS
- REMs and educational material
- REMs and healthcare professionals
- Pharmacy Systems under REMS
- Practice settings under REMS
REMS and RMPs
- Clinical Programme Product identified risks
- Differences in REMS and RMPs
- Crossover in REMS/RMPs
- Lifespan of REMS and RMPs
Managing a REMs programme
- Introduction of a REMS
- Assessment of the REMS programme
- Changes and amendments
- Safety reviews
For more information about this conference visit https://www.researchandmarkets.com/research/rnsl5m/an_introduction
