11/14/17
TransCelerate Biopharma Inc. has released a set of eConsent Assets as part of its eConsent Initiative.
ACRP RTP Fall Conference Announcement: Nov. 9-10, 2017
10/19/2017
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at ACRP: Research Triangle Park Chapter’s 18th Annual Fall Conference on Friday, November 10, 2017.
Topic: “Perspectives in Clinical Research"
When: Thursday, November 9 – Friday, November 10, 2017
Where: North Carolina Biotechnology Center (map)
This Thursday 10/19!! Regional ICH Consultation Public Meeting Announcement
10/17/2017
Meeting: “Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH).”
The Food and Drug Association (FDA) and Health Canada will be holding a Joint Public Consultation meeting.
Pennsylvania Supreme Court Ruling Requires Physicians to Personally Obtain Informed Consent
9/12/2017
What does that mean for the informed consent process for clinical trials?
Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard.
China becomes a New Regulatory Member of ICH!
8/28/2017
China Food and Drug Administration (CFDA) was accepted as a regulatory member in the International Council for Harmonisation (ICH) whose mission “is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.”