The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in Module 2 provide a critical analysis of the clinical data within the CTD.
This interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries. The programme will provide a review of the latest information and potential future developments and cover associated documents, such as the RMP and SmPC. A practical workshop session will simulate real situations and highlight the key issues to consider when preparing the content of the written summary.
Benefits of attending
- Gain practical advice on writing clinical documents for global submissions
- Review the latest guidance to ensure you meet regulatory expectations
- Understand how to prepare separate integrated summaries of efficacy and safety for the FDA
- Clarify the content of orphan drug applications, over-the-counter (OTC) switches, line extensions and safety-related labelling updates
- Ensure your risk management plan (RMP) is consistent with the Common Technical Document (CTD)
- Discuss the place of the clinical overview and summary in life cycle knowledge from initial IB to PSUR, and how they support the changing summary of product characteristics (SmPC)
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Day 1
The CTD Guideline
- CTD modules, structure and content
- An effective clinical overview
- The role of the written summary
- Agency validation
Planning content of the clinical overview
- Data sources
- Presenting efficacy and safety data
- Risk management
- Expressing benefit/risk
- Comparative effectiveness
- Avoiding pitfalls
Day 2
Content of the written summary - practical considerations including a workshop
- The document-writing process
- Templates
- Style
- Timelines
- Efficiency
- The writing team
- Engaging and working with external writers
- Getting started, and reviewing and interpreting data
- Document review: avoiding rework
- Achieving quality
- Document review and approval
Meeting regulators’ expectations
- The CTD in a global company: regional and country requirements
- Is a separate ISS or ISE necessary for an application to FDA?
- Writing for NCEs, orphan drugs, over-the-counter switches, MA renewal, generic products and line extensions
- Recent developments and their effect on producing future CTDs
- The RMP and risk evaluation and mitigation strategy (REMS)
- Writing an overview and summary to support the SmPC and labelling changes
