Overview
Course Structure
Week 1-2: Introduction & Global Regulatory
Frameworks
- Fundamentals of Regulatory
Affairs
- Overview of global
regulatory agencies (FDA, EMA, MHRA, TGA, CDSCO, PMDA)
- ICH guidelines and their importance
- Drug development lifecycle
(Preclinical, Clinical, Post-market)
- Roles and responsibilities
in Regulatory Affairs
Week 3: Regulatory Submissions & Documentation
- IND (Investigational New
Drug) & NDA (New Drug Application) – FDA
- MAA (Marketing Authorization
Application) – EMA
- ANDA (Abbreviated New Drug
Application) for generics
- CMC (Chemistry,
Manufacturing, and Controls) documentation
- Hands-on: CTD/eCTD dossier
preparation
Week 4: Clinical Trial Regulations & Compliance
- Global clinical trial approval
processes
- GCP (Good Clinical Practice)
and GMP (Good Manufacturing Practice)
- Ethical considerations and
IRB/IEC submission
- Adverse event reporting
& pharmacovigilance
- Hands-on: Clinical trial
protocol preparation
Week 5: Regulatory Strategy & Post-Market
Requirements
- Labeling, advertising, and
promotional regulations
- Post-marketing surveillance
& pharmacovigilance
- Medical devices &
combination product regulations
- Assignment: Prepare label,
brochure, and IFU (Instructions for Use)
Week 6: Know Your Documents
- Audit trail report, critical
subcontractor quality agreement, ISO certificate
- Risk management files and
biological evaluation reports
- PMS files, PSUR and PMCF
reports
- Hands-on Document Review
Week 7: Document Review
- Case study week: Real-life
client & manufacturer documents
Week 8: Project Preparation & Tool Training
- Project planning, tool
familiarization, query handling with manufacturers
Final Week: Capstone Project & Certification
- Real-world case studies
& regulatory strategy design
- Capstone Project: Prepare a
regulatory submission dossier
- Mock regulatory agency
review (Panel Presentation)
- Final assessment and
certification
