CPD Accredited • Evenings Classes • UK‑based
Regulatory Medical Writing Programme
8 weeks of live teaching with a 16-week completion buffer (6 months). Learn to author Protocols, CSRs, Module 2 summaries and IB updates with industry-standard simulations and 1–1 expert feedback.
8 + 16
Evenings
Simulated
1–1
CPD
Accredited
Time zone: Europe/London. UK’s leading training academy bridging healthcare professionals into pharma careers.
CPDÂ Accredited
Weekly evening classes
Industry-projects
Alumni community
Next Cohorts
Evening classes run 6 to 8 pm. Intake is limited for quality mentorship and 1-1 feedback.
| Start Date | Enrollment Deadline | Intake Size | Format | Action |
|---|---|---|---|---|
| 30 Oct 2025 | 29 Oct 2025 | Up to 30 | Live evenings | Enroll Now |
| 17 Nov 2025 | 16 Nov 2025 | Up to 30 | Live evenings | Enroll Now |
| 09 Dec 2025 | 08 Dec 2025 | Up to 30 | Live evenings | Enroll Now |
What you will Learn
Your portfolio mirrors industry expectations and proves capability.
Clinical Study Protocols
The synopsis, Objectives/Endpoints, Schedule of Activities, sections, references and traceability.
Clinical Study Reports
CSR Shells and the sources required, TFL Mapping, the art of data interpretation and concise narratives.
Module 2 SummariesÂ
The backbone and heart of submissions, how to author and produce reviewer-friendly summaries.
Ensuring alignment with ICH guidelines
Following QC checklist, use of tracked-changes and version control
Submission style templates for future use
Syllabus
Week 1: Introduction to Regulatory Medical Writing and Drug Development
Week 2: Clinical Study Protocols
Week 3: Clinical Study Protocol – SoA and Amendments
Week 4: Clinical Study Reports – Shell and TLFs mapping
Week 5: Clinical Study Reports – Interpreting TLFs
Week 6: Module 2 Clinical Summaries
Week 7: Investigator’s Brochures
Week 8: CV and Job Strategy
Roles & indicative UK compensation
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Refunds & Deferrals
14 day cool off period subject circumstances. Link to full policy here. Deferrals subject to availability.
Accessibility
We aim to support all learners. Tell us what you need and we will work with you.
No Job Guarantee
We provide training, coaching and references. Hiring decisions are made by employers.