We have added a new advanced elective module on Regulatory Affairs and Submissions to our curriculum, developed in consultation with industry practitioners.
Module contents:
- The regulatory landscape in India, the US and the EU
- CTD and eCTD dossier structure
- Preparing and reviewing regulatory submissions
- Post-approval changes and lifecycle management
- Interacting with regulatory authorities
Who it is for:
Students currently enrolled in the Advanced PG Diploma in Clinical Research, and working professionals looking to specialise.
Delivery:
The module runs as weekend sessions and includes practical dossier preparation exercises drawn from real submissions.
Enrolled students can opt in through the academic office. Working professionals may take this module as a standalone certificate — reach out via the Contact page for details.
New advanced module added: Regulatory Affairs & Submissions
Other Notifications
Interested in Our Courses?
Get free counselling for Clinical Research & Biotech programs.
Book Free Session