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 and Pharmacovigilance

Sheraton Philadelphia University City

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Philadelphia University City