Program Overview
This program equips experienced medical writers and reviewers with the tools, frameworks, and mindset to perform strategic reviews that add measurable value to regulatory and scientific submissions. Through a mix of conceptual learning, real-world case studies, and live simulations, participants will learn to identify clinical logic gaps, regulatory risks, statistical inconsistencies, and messaging misalignments that often compromise submissions. The course ensures participants leave with actionable strategies to improve document quality and strengthen cross-functional collaboration.
Features
- Differentiate tactical vs strategic review approaches for regulatory writing.
- Detect red flags in CSRs, protocols, and submission documents impacting compliance.
- Apply structured frameworks and tools for consistency, logic, and risk assessment.
- Deliver high-value, constructive feedback that strengthens regulatory submissions.
Target audiences
- Document Reviewers
- QC Leads
- Project Managers
- Professionals in medical writing, regulatory affairs, and publication management
Curriculum
- 7 Sections
- 31 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Instructor
