Biosimilars 2015

Hyatt Regency Bethesda

IOM Report on Sharing Clinical Trial Data

By Harold Glass, PhD; Christine Pierre, Society for Clinical Research Sites; DIA Global Forum Content Editors for Clinical Trials: Design Tools and Management

Sharing clinical trial data, in particular individual patient data, constitutes a major opportunity for new drug development and…

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

By Mark Geanacopoulos, PhD; Ruth Barratt, PhD, DVM; CDER, Office of Translational Sciences

Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with…

Budget, Funding and HTA Updates from Canada

By Judith Glennie, PharmD; President, J.L. Glennie Consulting, Inc., Canada

Outside of its regulatory responsibilities, the federal government’s role in the Canadian health system tends to be limited...

Advancing the Science of Study Endpoints

Hyatt Regency Bethesda

Pharmacovigilance and Risk Management Strategies 2016

Mandarin Oriental