Hello there,
Exciting News for Medical Writers!
MedWriters is thrilled to launch our Regulatory Writing Course — a 5-week journey through the most critical documents in clinical research and regulatory affairs.
This program is beneficial for aspiring or practicing medical writers, life science, medical, dental or pharmacy graduates, Clinical research professionals and Regulatory affairs associates. I am looking forward to have you in this program.
Ramesh Mylapilli (Program Co-ordinator)
December 2025 Cohort - Program Schedule
Registrations are closed for this cohort.
1. Introduction to Regulatory Writing – Completed
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Role of regulatory writers
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Overview of global health authorities
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Drug development lifecycle
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Types of regulatory documents
2. Global Regulatory Frameworks – Completed
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ICH guidelines
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FDA & EMA submission structure (eCTD)
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Regional variations (India, Japan, EU)
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Ethics & compliance
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Compare submission requirements for FDA vs. EMA.
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Assignment: Create a summary table of ICH E3, E6, E8 guidelines - 20 Credits.
3. Core Clinical Documents – IB & Study Protocol – Completed
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Investigator’s Brochure (IB)
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Clinical Study Protocol (CSP)
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Assignment: Draft the "Study Rationale" and "Objectives" sections for a mock protocol 20 Credits.
4. Core Clinical Documents – CSR & ICF – Completed
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Clinical Study Report (CSR)
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Subject Information Sheet / Informed Consent Form
5. Common Technical Document (CTD) and eCTD – 1 – Completed
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CTD modules 1–5
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Assignment: Prepare a “Module 2.5 – Clinical Overview” - 20 Credits.
6. Common Technical Document (CTD) and eCTD – 2 – Completed
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Writing summaries for Module 2 (QOS, Clinical Summary)
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Data presentation & tabulation standards
7. Non-Clinical and CMC Writing – Completed
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Preclinical data summaries
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Quality (CMC) documentation basics
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Specifications, manufacturing, stability reports
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Assignment: Write a “Product Description” section for a CMC module 20 Credits.
8. Safety and PV Documents – PSUR – 6 January, 7 to 9 PM.
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Periodic Safety Update Reports (PSURs)
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Assignment: Draft a summary of safety signals from provided data 20 Credits.
9. Safety and PV Documents – DSUR and RMP – 9 January, 7 to 9 PM.
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Development Safety Update Reports (DSURs)
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Risk Management Plans (RMPs)
10. Writing Style, QC and Career Building Aspects – 13 January, 7 to 9 PM.
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Regulatory writing style (clarity, consistency, accuracy)
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Use of templates, checklists, and references
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QC and document review process
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Portfolio creation
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Job roles & freelancing
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Interview & submission readiness
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Ethical considerations