Regulatory Guidance and Communications
We help our RMCE partners understand the legal and regulatory environment applicable to them for regenerative and personalized medicine procedures, as well as maintain appropriate interaction with relevant regulatory authorities.
The delivery of healthcare in today’s environment requires awareness of and compliance with a plethora of regulatory requirements. This is particularly true in regenerative and personalized medicine. Regulatory authorities recognize the promise of cell-based and similar therapies on the one hand, and the potential for patient harm by bad actors”. Transparency with national and regional regulatory authorities is a core principle of any RMCE.
This transparency begins with an early meeting with those authorities, and a description of evidence-based protocols, data collection/reporting procedures, nature of planned marketing and communications programs for patients and HCP’s. Regen Med, on behalf of the RMCE, continues to engage with authorities, including through sharing of registry data, education as requested on developments in evidence-based regenerative/personalized medicine, and reviews of ongoing studies at the RMCE and elsewhere in the Regen Med Network.