Home/Programmes/Regulatory Programme
Legal Aspects of
Regenerative Medicine
The regulatory framework, consent standards, liability exposure and ethics governance that every practitioner in this field needs and few receive.
- 3 monthsDuration
- UnlimitedCohort
- 20 creditsCME
The Programme
Who this is for
Regenerative medicine sits in a genuinely difficult regulatory space, and the consequences of getting it wrong fall on the practitioner. This programme is taught jointly by our regulatory lead and an external healthcare lawyer.
- 3 monthsDuration
- UnlimitedCohort size
- 20 creditsCME credits
- OnlineFormat
Curriculum
Four modules
Taught in sequence. Each builds directly on the one before it.
- 01
The regulatory landscape
How cellular products are classified in India and internationally, and where minimal manipulation ends and manufacturing begins.
- 02
Consent that stands up
What informed consent requires when the evidence base is incomplete, and how to document uncertainty honestly.
- 03
Liability & indemnity
Where professional exposure actually lies, what indemnifiers require, and the documentation that protects you.
- 04
Ethics governance
Constituting an ethics committee, running it independently, and handling adverse events and complaints.
On Completion
What you will be able to do
Assessed, not assumed. Each outcome is signed off before certification.
Draft consent documentation that discloses genuine uncertainty
Establish or strengthen local ethics governance
Regulatory Programme
- 0+Practitioners trained
- 0Countries represented
Almost every practitioner we teach has been operating on assumptions about their regulatory position that turn out to be wrong.
AISRM FacultyAgathisha Institute of Stem Cells and Regenerative Medicine
Places for the next intake
Tell us your background and what you intend to do with the training.