Membership organizations such as ours have a role and responsibility to educate government agencies about the profession they represent.
The Association Board of Trustees agrees and in January 2010 they formed the Regulatory Affairs Working Group, which is now known as the Regulatory Affairs Committee. The Regulatory Affairs Committee became a standing committee in January 2011 with a mission to educate and work collaboratively with relevant regulatory agencies, legislatures, and other government entities and officials to enhance the protection of human subjects that participate in clinical research and to advance the interests of the clinical research profession.
“What is in it for me?” you might ask. This committee will advocate on your behalf by communicating your perspectives and points of view to regulatory agencies like the Food & Drug Administration (FDA), the European Medicines Agency (EMA), or Health Canada. And you can actively participate without being a member of the committee.
The FDA recently requested comments on a draft guidance pertaining to medical devices. While committee members are familiar with medical devices, they took an inclusive approach to responding to this document by posting a request in the ACRP Online Community for help with formulating comments.
ACRP will continue providing you with a powerful voice going forward, and the committee volunteers and staff are excited about bringing you this benefit!
JIM THOMASELL is the Executive Director of the Association of Clinical Research Professionals (ACRP) and its affiliates, the Academy of Pharmaceutical Physicians and Investigators (APPI) and the Academy of Clinical Research Professionals (The Academy). The association provides certifications and professional development to 18,000 diverse clinical research professionals around the globe.