8/24/2017
Registration now open!
Certification Exam Prep Course
Presented by: Laurin Mancour, CCRA
Date: Saturday, August 26
Time: 9:00 am – 5:00 pm
Location: Premier Research (1 Park Drive, Research Triangle Park, NC 27709)
Update to "Is it SRS, cIRB or sIRB? A guide to understanding the June 2016 NIH Single IRB Policy" – NOW Effective January 25, 2018
7/13/2017
**UPDATED EFFECTIVE DATE** The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
Join us tonight for a discussion on "How Does the Recent ICH-GCP E6 Update Affect YOU?"
6/15/2017
Our own SAM Sather will be in the ACRP's Northern California chapter for a discussion of the guideline updates, impact assessment, and a scalable approach to implementation of ICH-GCP E6 R2. For more information click here.
Brexit impact on Current and Future Trials in the European Union
5/4/2017
Since March 29th 2017 when the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), the clinical research industry has been wondering about the implications of this unprecedented withdrawal particularly since the European Commission and EMA believe that the UK will no longer participate in the EMA’s work after March 30th of 2019.
Pediatric Clinical Trials: Special Considerations and Requirements - Attend the May 15th WEB Session”
5/2/2017
Date: May 15, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
Description:
Pediatric clinical trials present unique challenges since minors, as a vulnerable population, require a variety of regulatory protections to be incorporated as part of the study’s design, recruitment strategies, and monitoring plan.