CDISC Blog filter by date: June 2010at 2:54 PM by cdisc
June has been a month full of interesting meetings, events and activities for CDISC. In particular, Bron Kisler and I attended a set of meetings in the Washington, DC area 8-11 June while others within CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project.
Tags: Terminology, SHARE, FDA, CDASH,
at 3:08 PM by cdisc
The Critical Path to TB Drug Regimens (CPTR) is a recently formed collaboration of global pharmaceutical companies; government and regulatory agencies; foundations and donors; academia; and patient advocacy groups. The CPTR initiative was created and is managed by a partnership of the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (Global TB Alliance) and the Critical Path Institute (C-Path).
at 4:51 AM by cdisc
Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register. In this blog are a few highlights that I have pulled from each of the documents…but, please read them yourselves and please sign up to attend the webinar on 29 June to hear directly from CBER and CDER representatives, Amy Malla and Dr. Chuck Cooper.
Tags: CBER, FDA, PDUFA, Standards, ODM, CDER, CDASH SDTM,