Overview
Week 1-2: Regulatory Affairs Foundation
- Introduction to Regulatory
Affairs
- Global Regulatory Agencies:
FDA, EMA, MHRA, TGA, CDSCO, PMDA
- ICH Guidelines (Q, S, E, M
series)
- Drug Development Lifecycle
(Preclinical to Post-market)
- IND, NDA, ANDA, MAA overview
Week 3: Regulatory Documentation & Dossier
- CTD/eCTD Structure &
Compilation
- CMC Documentation
- Labeling, IFU, Brochure
Development
- Regulatory Strategy
Assignment
Week 4: Clinical Trial Regulations
- GCP, GMP, and Ethical
Considerations
- IRB/IEC Submissions
- Clinical Trial Protocol
Development (Hands-on)
- Pharmacovigilance Basics
Week 5: Clinical Data Management Introduction
- Role of CDM in Clinical
Trials
- Data Types, Sources, and
Structures
- Introduction to CDMS and EDC
Systems
- ALCOA+ Principles and Data
Standards (CDASH, SDTM)
Week 6: CDM Tools & Practices
- CRF Design & Data Entry
Process
- Data Cleaning, Validation
& Query Management
- Risk-Based Monitoring (RBM)
and ePRO
- SAE Reconciliation and
Safety Data Management
Week 7: Pharmacovigilance Essentials
- Adverse Event, SAE, SUSAR
Definitions
- Case Processing Lifecycle
- Narrative Writing, MedDRA
Coding
- CIOMS, PSUR, and DSUR
Overview
Week 8: Post-Market Safety & Compliance
- Post-marketing Surveillance
Systems
- Signal Detection and
Benefit-Risk Assessment
- Audit Trails &
Regulatory Compliance (21 CFR Part 11)
- EDC Implementation Practice
Assignment
Week 9: Practical EDC/CDMS Implementation
- Hands-on Project in Veeva
Vault/EDC Tool
- Study Build, Document
Upload, Versioning
- Data Extraction and
Reporting
- Approval Workflow &
Audit Trail Management
Week 10: Advanced Regulatory & Safety
Submissions
- eCTD Software Training &
Submission Practice
- Pharmacovigilance Report
Submissions
- Data Integration Between RA,
CDM, and PV
- Hands-on Document
Compilation
Week 11: Role-Based Training and Interview
Preparation
- Role Training: Data Manager,
PV Officer, Regulatory Associate
- Resume Building, LinkedIn
Optimization
- Mock Interviews: RA/CDM/PV
- Freelancing Opportunities
Week 12-13: Capstone Project and Certification
- Simulated Regulatory
Submission Dossier
- Safety Narrative Writing +
CRF Data Cleaning
- Final Project Submission and
Evaluation
- Mock Review Panel &
Certification Ceremony
