Department of Biotechnology Government of India

National Regulatory Professionals Development Program 2026

10 - 14 March 2026 | IIT Delhi

Building India's Future-Ready Regulatory Workforce

A National Capacity-Building Initiative for Biopharma & Medical Devices

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Building India's Future-Ready Regulatory Leaders in Biopharma and Medical Devices

India's life sciences ecosystem is undergoing a rapid transformation—driven by innovation, global regulatory convergence, advanced therapies, and medical devices. This National Regulatory Professionals Development Program is a first-of-its-kind, industry-led masterclass series designed to strengthen regulatory, quality, and safety capabilities across the product lifecycle. This initiative directly supports India's vision of regulatory excellence, global competitiveness, and skilled workforce development in biopharma and medical devices—two of the country's fastest-growing strategic sectors.

The program integrates policy, practice, and real-world execution, delivered by current & former regulators, senior industry leaders, and global compliance experts. All participants will receive a National Certificate of Participation issued jointly by Department of Biotechnology, Government of India; BIRAC, CDSCO; World Health Organization; IIT Delhi; Life Sciences Sector Skill Development Council and Cliniminds, recognizing advanced regulatory capability development.

Program Structure

A 5-Day National Program, delivered through two focused Masterclasses:

Masterclass 1

Biopharma Regulatory Excellence (2 Days)

  • ▶ Indian and global biopharma regulatory landscape
  • ▶ Drug development pathway and CTD/eCTD dossiers
  • ▶ Regulatory strategy, intelligence, and change management
  • ▶ Pharmacovigilance principles and safety regulations
  • ▶ Pharmaceutical QMS, GMP, GLP, and GCP essentials
  • ▶ Data integrity, ALCOA+, GDP, and documentation practices

Fee: ₹10,000 + 18% GST

Masterclass 2

Medical Devices Regulatory & Quality Systems (2 Days)

  • ▶ Indian medical device regulatory framework
  • ▶ Quality systems framework, ISO 13485
  • ▶ Technical documentation & Materiovigilance
  • ▶ Risk management principles and ISO 14971
  • ▶ General safety and performance requirements
  • ▶ Clinical evidence, ISO 14155-aligned clinical investigations

Fee: ₹10,000 + 18% GST

Both programs Includes One Day Industrial Visit
Participants may enroll in one Masterclass or attend the complete Program

Who Should Attend?

Ideal for start-up founders, regulatory, quality, clinical, and medical affairs professionals across biopharma and medical devices. Also suited to industry leaders, scientists, managers, policy-facing professionals, and academicians engaged in healthcare innovation.

Faculty & Leadership

Program led by current and former CDSCO leaders, senior industry regulatory heads, and global GxP, PV, and medical device experts with hands on experience across Indian, FDA, EMA and MHRA regulatory framework.