We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. This is a popular event designed for staff who are new to the FDA regulatory world or those who just need a...
Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...
The St. Vincent Research and Regulatory Affairs will be hosting the 9th Annual St. Vincent Health Research Symposium next month. This daylong event will feature keynote speakers, William Droegemueller, MD, Distinguished Clinical Professor, Obstetrics and Gynecology at...
IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
Join Pearl Staff at the ‘Celebration of Life Sciences in Indiana Networking Reception’ hosted by the RAPS Indiana Chapter. The focus of the event is to promote new connections among local regulatory professionals. A BioCrossroads representative will also...
