Blog
Single IRB requirement intended to streamline multi-site clinical research
Beginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB...
RMAT Designation from the 21st Century Cures Act now live
The 21st Century Cures Act, signed into law on December 13, 2016, includes several provisions related to regenerative medicine. Regenerative medicine covers a wide range of innovative products including cell therapies, therapeutic tissue engineering products, human...
RAPS seeking nominations for 2018-2020 Board of Directors
Regulatory Affairs Professionals Society (RAPS) is seeking qualified individuals to serve on the RAPS board of directors for the 2018-2020 term. RAPS, the largest global organization of and for those involved with the regulation of healthcare and related products...
Diana Caldwell speaking at 3rd annual KLLC Women’s Empowerment Retreat on March 3rd
On March 3rd, the Indiana University Kelley Living Learning Center (KLLC) will be hosting their third annual Women’s Empowerment Retreat. This impactful event gives 50 first-year KLLC women an opportunity to network with successful business women and learn how to be a...
Indy Life Science event this Thursday
Thursday, February 23, Hoosiers Work for Health will host an event, Indiana Life Sciences Industry Update: Key federal issues including PDUFA. The federal briefing will feature Alicia Subasinghe of Pharmaceutical Research and Manufacturers of America, Washington D.C....