Blog
Accelerating clinical trials during an epidemic
How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies...
Workforce Issues – Life Sciences Human Capital
Indiana University’s Kelley School Center for the Business of Life Sciences will host a conference titled “Workforce Issues – Life Sciences Human Capital.” The full-day conference will take place on Friday, May 12, 2017 at the Cook Group Headquarters in Bloomington,...
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...