As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).

Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.

This audio conference covers:

• Designing and using an appropriately detailed narrative template
• Writing narrative text including in-text tables of laboratory, vital sign, or ECG results when necessary
• Requesting data displays for use in safety narratives (e.g., dates vs. durations, verbatim vs. coded drug names)
• Using samples and batching to improve the preparation and review of narratives
• Tracking narrative preparation with a list that can also be used in the marketing application as a narrative table of contents

About the speaker:

Dr. Susan Coleman Sisk, RAC, has 15+ years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. After starting her pharmaceutical career in genetic toxicology, she decided to combine her ability to analyze data with her aptitude for clearly communicating complex scientific results, and she became a medical writer at ClinTrials Research. There she managed large, multidocument writing projects and performed regulatory tasks for study startups and submissions. She was promoted to Associate Director of Regulatory Affairs and provided regulatory services in this role and as a Senior Regulatory Scientist at Ingenix.

In 2001, she joined Schwarz Biosciences as a regulatory project leader and FDA liaison, then helped start and build a high-performance medical writing group, including setting up company infrastructure such as standard operating procedures, regulatory document guidance and templates, writing conventions, and quality control specifications. Her work included process management and preparation of marketing applications for FDA and European Union Competent Authorities, using the CTD format for both paper and electronic submissions.

In early 2006, she founded SFP Consulting, LLC, a company providing medical writing services and regulatory submissions project management to support development of healthcare products. Dr. Sisk also provides training, including instruction and practice on preparing regulatory submission documents (especially those in the CTD) and process optimization. Dr. Sisk is also an authorized facilitator for the MeduMAZE Drug Development and Approval Game. This board game, when combined with a didactic component, brings the medicine development process (from early nonclinical testing through government approval and marketing) to life and teaches the importance of good science and planning in a relaxed and enjoyable way.

Who should attend?

• Clinical Operations
• Medical Writers
• Directors, Medical Writing
• Managers, Medical Writing
• Drug Safety Officers
• Regulatory Affairs Managers