Curriculum
- 7 Sections
- 29 Lessons
- 1 Day
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- 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
Hands-on activity: Drafting a short Protocol synopsis or ICF section
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