Several FDA personnel and industry experts will cover current regulatory and reimbursement issues, latest government policies, healthcare reform and implications for diagnostics.
Agenda topics include:
– Recent developments in government policy and diagnostics
– Software implications for IVDs
– Panel on the regulation of LDTs
– Developments in companion diagnostics and personalized medicine
– Molecular submissions
– The OIR Perspective for 2015
Registration fee includes access to presenter materials and slides, meals (breakfast&lunch), and a networking reception.
Alberto Gutierrez, Director, OIR/FDA
Reena Philip, Director, DMGP/OIR/FDA
Yun-Fu-Hu, Branch Cheif, MPCB/DMGP/OIR/FDA
Andrew Grove, Microbiologist, DMD/OIR/FDA