FALLS CHURCH, Va., Nov. 9, 2012 /PRNewswire-iReach/ --
Fifth Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management and Drug Safety Program
**Presented by FDAnews**
Dec. 3-4, 2012 – Washington, DC
There are now about 200 unique REMS and four classwide REMS. And big changes are coming.
PDUFA V moves REMS discussions earlier in the review process for sponsors of new molecular entity NDAs and original BLAs. With REMS discussions commencing as early as pre-NDA meetings, the agency is determining how to create a more predictable system for requiring REMS and deciding what tools a REMS should involve.
CDER (in conjunction with CBER) plans to issue new guidance to determine when a REMS is required, both preapproval and postapproval. The guidance must be released in September 2013.
Plus, the FDA is planning to hold a series of public meetings to determine the best methods for assessing the effectiveness of REMS.
Are you in the know on these changes? Will you be ready when they hit your product?
Register today to join a select group of drug industry executives who have, over the past four years, sought to shape the future of REMS and global drug safety.
This is your year to be among them. Register now to join with colleagues for the Fifth Annual Risk Management and Drug Safety Summit.
Invest two days. Meet new colleagues and make new contacts. Ask questions directly of industry thoughts leaders, such as Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited), Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company and Ri
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