Program Overview
This program introduces participants to the fundamentals of regulatory medical writing, a critical function in drug development and clinical research. It covers the structure and purpose of essential documents such as Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Informed Consent Forms (ICFs), while grounding learners in the key ICH guidelines (E3, E6, E9) and principles of Good Clinical Practice (GCP). Through conceptual sessions, situational case walkthroughs, real-world examples, and live writing simulations, participants gain practical insights into document QC, compliance risks, and stakeholder expectations. Designed and delivered by a senior industry expert with 25+ years’ experience, the course equips life sciences professionals with the knowledge, frameworks, and tools required to transition into or grow within regulatory writing roles.
Features
- Understand the role and value of regulatory writing in drug development.
- Differentiate between regulatory, scientific, and medical communications writing.
- Apply ICH guidelines (E3, E6, E9) to core clinical documents.
- Identify common pitfalls and compliance risks in protocols, CSRs, IBs, and ICFs.
Target audiences
- Clinical research professionals
- QC/QA Professionals
Curriculum
- 7 Sections
- 29 Lessons
- 1 Day
- Introduction to Regulatory Medical Writing4
- 1.1What is regulatory medical writing & why it matters in drug development lifecycle
- 1.2Distinguishing regulatory writing vs scientific/marketing communication
- 1.3Key stakeholders: Sponsors, CROs, Regulatory Authorities (FDA, EMA, DCGI, PMDA)
- 1.4Key Terms: submission readiness, dossier development, regulatory compliance
- Clinical Development Phases & Writer’s Role4
- Core Regulatory Documents – Structure & Purpose6
- 3.1Protocol: scientific rationale, study design, inclusion/exclusion criteria
- 3.2CSR (Clinical Study Report): efficacy, safety, statistical interpretation
- 3.3Investigator’s Brochure (IB): risk-benefit summary for investigators
- 3.4Informed Consent Form (ICF): ethics, readability, patient-centricity
- 3.5Real-life examples: Protocol misalignment, CSR rejected by regulators, ICF ethics board queries
- 3.6Key Terms: ICH E3 template, CTD modules, informed consent readability index
- ICH Guidelines & GCP Compliance5
- 4.1ICH E3: Structure and content of CSRs
- 4.2ICH E6(R2): Good Clinical Practice (ethics, monitoring, responsibilities)
- 4.3ICH E9: Statistical principles – endpoints, analysis sets, data handling
- 4.4GCP compliance and its implications for document integrity
- 4.5Case Studies: When guideline non-compliance led to FDA queries
- Writing Do’s, Don’ts & Common Pitfalls4
- Document QC & Stakeholder Expectations4
- Live Writing & Review Simulation2
Instructor
