Regulatory Submissions, Information, and Document Management Forum

Bethesda North Marriott Hotel and Conference Center

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…

Physician Education Improves Health for Patients - and for Industry

From the Institute of Clinical Research in Mumbai to the European Academy of Clinical Research in Belgrade, the global need...

Postmarketing Drug Safety & Pharmacovigilance

Sheraton Philadelphia University City

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Philadelphia University City