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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Advanced Regulatory & Clinical Writing Learning Path
4.7
★★★★★
97% Recommended
Updated 2025
16 hours
0 active users
16 points
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Each course includes:
Fully compliant
This learning path is aligned with ICH E3 (Clinical Study Reports), ICH E6 (R3) GCP, ICH E8 (General Considerations for Clinical Studies), EU MDR 2017/745 MEDDEV 2.7/1 Rev 4 (Clinical Evaluation), EU CTR 536/2014, and FDA submission guidance — providing senior-level regulatory and clinical writing competency across pharmaceutical and medical device regulatory dossiers. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam does not mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The Advanced Regulatory & Clinical Writing Learning Path is designed for experienced medical writers and regulatory professionals seeking to develop senior-level competency across the most complex and high-value document types in pharmaceutical and medical device regulatory submissions. Covering Clinical Study Report preparation, protocol and informed consent writing, investigator brochures, Clinical Evaluation Report writing under EU MDR, medical device regulatory documentation, and ISO 14971 risk management writing, this programme provides the advanced writing and regulatory knowledge required to lead the production of submission-critical documents across both pharmaceutical and device regulatory dossiers.
Participants will develop the ability to author, manage, and quality-review the full range of regulatory and clinical documents required for NDA, MAA, BLA, and EU MDR technical file submissions — including the strategic writing skills needed to communicate complex clinical data, benefit-risk conclusions, and safety evaluations clearly and compliantly to global regulatory authorities.
How this differs from the Pharmacovigilance & Safety Writing Specialist Learning Path
The Advanced Regulatory & Clinical Writing Learning Path focuses on clinical trial and regulatory submission documents — CSRs, protocols, informed consent forms, investigator brochures, clinical evaluation reports, and device regulatory writing. It is designed for writers whose primary outputs feed directly into regulatory dossiers and marketing authorisation applications.
In comparison, the Pharmacovigilance & Safety Writing Specialist Learning Path focuses on post-market safety writing — ICSRs, PSURs, PBRERs, signal reports, and literature monitoring documentation. Together, these two specialist paths cover the complete professional medical writing landscape from clinical development through to post-approval safety surveillance, and are designed to be taken in sequence following the Foundations of Medical Writing Learning Path.
Who should enrol:
- Medical Writers
- Regulatory Affairs Professionals
- Clinical Research Associates
- Clinical Scientists
- Pharmacovigilance Professionals
- Medical Affairs Personnel
- Life Science Graduates
- and professionals looking to advance their careers in regulatory and clinical writing.
What you will learn
Master advanced regulatory, clinical, and medical writing principles used across the pharmaceutical and healthcare industries.
Develop, structure, and manage clinical and regulatory documents in compliance with global standards and submission requirements.
Understand ICH guidelines, regulatory submission processes, document lifecycle management, and best practices for compliance.
Present clinical data, safety information, and scientific evidence effectively while enhancing communication skills for diverse audiences.
Courses Included
Core pharmacovigilance fundamentals — ADR classification, causality assessment, EU and FDA spontaneous reporting requirements, and MAH PV obligations
3 hours
2 points
Develop the advanced writing expertise needed to support regulatory submissions and clinical development programs across the pharmaceutical, biotechnology, and medical device industries.
3 hours2 points
Gain comprehensive expertise in medical device development, clinical investigations, regulatory compliance, post-market surveillance, and risk management across the entire product lifecycle.
3 hours2 points
PBRER structure and ICH E2C(R2) alignment — integrated summary of safety, benefit-risk conclusions, and regulatory submission writing for periodic aggregate reports
2 hours3 pointsSystematic literature monitoring under GVP Module VI — search strategy design, triage, case identification, and documenting literature screening outcomes
2 hours3 pointsWriting risk management documentation for medical devices — risk management plan, risk analysis reports, risk evaluation summaries, and benefit-risk determination sections within clinical evaluation reports
3 hours2 pointsOur Certified Customers
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Frequently Asked Questions
- Experienced Medical Writers progressing into senior clinical and regulatory writing roles
- Regulatory Affairs Specialists responsible for clinical sections of NDA, MAA, or BLA dossiers
- Clinical Research Associates and Clinical Operations professionals moving into medical writing
- Medical Device Regulatory Writers and Clinical Affairs specialists
- Clinical Evaluation Report (CER) authors and reviewers in medical device companies
- Protocol and informed consent writing leads in sponsor and CRO organisations
- Professionals who have completed the Foundations of Medical Writing or PV & Safety Writing Specialist Learning Paths and are seeking advanced regulatory writing development
- Life sciences professionals with scientific or clinical backgrounds transitioning into senior regulatory writing roles
- Author and manage ICH E3-compliant Clinical Study Reports, integrating clinical narrative, statistical outputs, and appendix documentation to produce submission-ready dossier components for NDA, MAA, and BLA applications.
- Write and review clinical trial protocols, investigator brochures, and informed consent forms in compliance with ICH GCP E6 (R3), EU CTR 536/2014, and FDA guidance — applying plain language principles and regulatory review standards across diverse study populations and jurisdictions.
- Prepare Clinical Evaluation Reports (CERs) and post-market clinical follow-up documentation under EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4, integrating clinical data appraisal, benefit-risk determination, and state-of-the-art literature analysis.
- Produce risk management documentation for medical devices in line with ISO 14971:2019 and write device regulatory submission documents under ISO 14155:2026 — applying advanced regulatory writing skills across both pharmaceutical and medical device dossier requirements.
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