Curriculum
- 7 Sections
- 31 Lessons
- 1 Day
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- Redefining the Role of a Reviewer4
- Dimensions of Strategic Review6
- 2.1Clinical logic check – Are endpoints, efficacy & safety data aligned?
- 2.2Regulatory risk assessment – Spotting vulnerabilities in protocols, CSRs, ISS/ISE
- 2.3Statistical integrity – Detecting inconsistencies in tables, figures, listings (TFLs)
- 2.4Messaging precision – Ensuring core scientific story, key messages, and labeling alignment
- 2.5Key Terms: submission compliance, dossier quality, CTD modules, GCP alignment
- 2.6Situational exercise: Reviewing a protocol synopsis with hidden inconsistencies
- Levels of Review – The Layered Approach5
- 3.1Technical: formatting, references, templates
- 3.2Language: readability, clarity, regulatory style guides (eCTD, AMA)
- 3.3Compliance: ICH, GCP, E3 guidance, company SOPs
- 3.4Strategic: big-picture positioning & regulatory acceptability
- 3.5Case-based discussion: Review escalation at different levels – when to stop, when to deep-dive
- Red Flags & Quality Signals in Documents5
- 4.1Missing/ambiguous endpoints, inconsistent data across documents
- 4.2Over-interpretation of results, regulatory non-acceptability risks
- 4.3Real-world examples of FDA queries, EMA objections, Health Authority rejections triggered by poor reviews
- 4.4Key Terms: regulatory inspection readiness, data traceability, quality culture
- 4.5Case Study: When a review saved a submission – and when it failed
- Tools, Frameworks4
- 5.1Structured review frameworks (5C model: Clarity, Consistency, Compliance, Clinical logic, Communication)
- 5.2Reviewer’s checklists for CSRs, Protocols, CTD summaries
- 5.3Tools: Track changes, redlining, annotation conventions, QC matrices
- 5.4Situational drill: Spot-the-error using a structured checklist
- Collaborative Review & Feedback Mastery4
- 6.1Reviewer–Author dynamics: Giving feedback that drives improvement, not conflict
- 6.2Techniques for constructive critique, review consolidation, and team alignment
- 6.3Key Terms: document governance, authoring alignment, cross-functional synergy
- 6.4Group exercise to consolidate conflicting reviewer comments
- Simulation – Reviewer in Action3
Role of the reviewer in regulatory success and risk mitigation
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