Advanced Diploma in Global Regulatory Affairs & Compliance

Weekly Breakdown

Module 1: Trial Design & Ethics (Weeks 1–6)

Module 2: Monitoring & GCP Compliance (Weeks 7–12)

Module 3: Clinical Data Management & Biostats (Weeks 13–18)

Module 4: DCT & AI in Research (Weeks 19–24)

Learning Outcomes

Assessment Weightage

Program Details

🕰️ Duration:
6 Months (24 Weeks)
🧩 Structure:

4 Intensive Modules +1 Capstone Project
🧠 Delivery:

Practical Workshops (Dossier Authoring), Case Studies, and AI Tool Application
🎯 Focus On:

Advanced Program Structure & Delivery

🎓 Applicable Audience

B.Pharm M.Pharm D.Pharm BPT BHMS BAMS BDS MBBS Nursing B.Sc BA BCOM MCOM BTECH MTECH MA

Detailed Syllabus & Weekly Breakdown

Module 1: Regulatory Foundations & Laws (Weeks 1–6)

Week 1-2: Global Regulatory Landscape; FDA (NDA/ANDA), EMA, CDSCO pathways
Week 3-4: Generic Drug applications; GDUFA; Hatch-Waxman Act
Week 5-6: Emerging Markets (ASEAN/GCC); Regulatory Intelligence basics

Module 2: The CTD/eCTD Framework (Weeks 7–12)

Week 7-8: Modules 1–5 deep dive; Chemistry, Manufacturing & Controls (CMC)
Week 9-10: Labelling and Artwork; Drafting SmPC, PIL, and USPI
Week 11-12: Pre-clinical and Clinical summaries (Modules 2, 4, 5)

Module 3: Submissions & Lifecycle Management (Weeks 13–18)

Week 13-14: eCTD Publishing and Validation software training
Week 15-16: Post-approval changes (Variations/Amendments); Renewals
Week 17-18: Medical Device Regulations (MDR/IVDR) and Combination Products

Module 4: AI & Future of Regulatory (Weeks 19–24)

Week 19-20: GenAI for automated dossier authoring and query responses
Week 21-22: IDMP Standards; Digital Compliance Audits; Sustainability
Week 23-24: Capstone: Global Submission Strategy for a Complex Generic Product

Learning Outcomes & Assessment

Navigate submission requirements for major global regulatory authorities
Compile and publish an eCTD dossier following validation rules
Manage post-approval variations and lifecycle updates
Leverage AI tools for regulatory intelligence and automation

Assessment Weightage

Dossier Authoring (Module 2/3 focus): 50%
Regulatory Strategy Presentations: 25%
Final Capstone Project: 25%

Term and Credit Structure

Term	Module	Weeks	Credits
Term 1	Module 1: Regulatory Foundations & Laws	1–6	4
Term 1	Module 2: The CTD/eCTD Framework	7–12	4
Term 2	Module 3: Submissions & Lifecycle Mgmt	13–18	4
Term 2	Module 4: AI & Future of Regulatory	19–24	4
Total		24 Weeks	16 Credits