We are pleased to announce that our own, Gretchen Bowker, will be moderating the Association of Food and Drug Officials (ADFO) meeting today June 22nd. The AFDO is holding their event this week from June 20th to June 24th in Indianapolis at the Sheraton Indianapolis...
Sarah Witwer will be teaching for the third time in Orthopedic Regulatory and Clinical Affairs Program this fall at Grace College. She has three decades of practice in the life science industry and is a Pearl Pathways Regulatory Compliance Advisor. Sarah is well...
According to an article on Outsourcing-Pharma.com, a new study indicates that the regulation of clinical trials in other regions of the world is too rigorous, urging pharma firms and CROs to create designs that are universal. The article entitled, “Trial regulation in...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?