Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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 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)