Regulatory Writing
January 2026 Cohort

1. Introduction to Regulatory Writing - Completed​

​​

• Role of regulatory writers

• Overview of global health authorities

• Drug development lifecycle

• Types of regulatory documents

​

2. Global Regulatory Frameworks- Completed

​

• ICH guidelines

• FDA & EMA submission structure (eCTD)

• Regional variations (India, Japan, EU)

• Ethics & compliance

• Compare submission requirements for FDA vs. EMA.

• Assignment: Create a summary table of ICH E3, E6, E8 guidelines - 10 Credits.

​

3. Clinical Trial Protocols: Structure, Content, and Compliance - Completed

​

• Purpose and importance of clinical trial protocols

• Key sections of a clinical trial protocol

• Study design, objectives, and endpoints

• Regulatory and ethical considerations (ICH-GCP)

• Assignment: Draft an outline of a clinical trial protocol 

​

4. Investigator’s Brochure: Structure, Content, and Purpose - Completed

​

• Purpose of the Investigator’s Brochure

• Structure and key sections of an IB

• Non-clinical and clinical data presentation

• Safety information and risk communication

• Assignment: Prepare an Investigator’s Brochure for Diazepam.

​

5. Informed consent document (ICD): Scientific and Regulatory Requirements - Completed

​

• Purpose of informed consent in clinical trials

• Essential elements of an ICD

• Ethical principles and subject rights

• Writing patient-friendly consent language

• Assignment: Draft a simplified informed consent summary (1–2 pages) for a hypothetical clinical study.

​

6. Fundamentals of Clinical Study Report Preparation & Patient Narrative - Completed

​

• Purpose and structure of Clinical Study Reports (CSR)

• Overview of ICH E3 guideline

• Data presentation and interpretation in CSRs

• Patient narratives: purpose and structure

​

7. Common Technical Document (CTD) –Overview and Structure - Completed

​

• Introduction to the CTD format

• Overview of CTD Modules 1 to 5

• Role of CTD in global regulatory submissions

• Regional considerations in CTD submissions

​

8. CTD Module 2: Clinical Summaries and overview - Completed

​

• Purpose of CTD Module 2

• Structure of clinical summaries and overviews

• Summarizing clinical efficacy and safety data

• Linking Module 2 summaries with CSRs

​

9. Non-Clinical Reports in Regulatory Submissions - 24 Feb - 7 to 9 PM

​

• Role of non-clinical studies in drug development

• Types of non-clinical reports

• Structure of non-clinical study reports

• Integration of non-clinical data into CTD

• Assignment: Identify key non-clinical studies required before first-in-human trials and explain their purpose.

​

10. Aggregate Safety Reporting: Writing and Regulatory Compliance - 27 Feb - 7 to 9 PM

​

• Overview of aggregate safety reports

• Types of aggregate reports (PSUR, DSUR, PBRER)

• Safety data analysis and signal evaluation

• Regulatory timelines and submission requirements

​

11. Risk Management and Clinical Evaluation Documents - 03 March - 7 to 9 PM

​

• Purpose of risk management documentation

• Key components of a Risk Management Plan (RMP)

• Overview of Clinical Evaluation Reports (CER)

• Benefit–risk assessment principles

• Assignment: Draft a high-level risk–benefit summary for a medicinal product.

​

12. Career Pathways in Regulatory Writing & Mock Interview Session - 06 March - 7 to 9 PM

​

• Career opportunities in regulatory writing

• Required skills and qualifications

• Entry-level vs experienced regulatory roles

• Resume and interview preparation tips