Event Details

Narratives are an integral part of medical writing. Sponsors sometimes need to prepare large batches of these deliverables in a short period while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions and potential discrepancies in the reporting of a drug’s safety. Fortunately, through the advancement and use of technology and other streamlined writing approaches, there are options to deliver high quality narratives on time. In this presentation, you will gain a new perspective on the future of patient narrative production. You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.  

Our resident narrative and transparency and disclosure experts will provide the tools and tips needed to ensure quality, consistency, efficiency, and cost-savings imperative to the narrative generation process. We will identify the past and current health authority review process, discuss how to work through complicated or dense data to produce a streamlined narrative for submission, and highlight efficiencies gained through the application of technology into the narrative process.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives

• Upon the conclusion of the program, you will be able to:
• Understand the present and future state of patient narratives.
• Gain a better understanding of the transparency initiative surrounding patient narratives.
• Recognize the quality and consistency gained through the use of technology and streamlined templates when submitting patient narratives to health authorities or for public consumption.

Who Should Attend

• Medical writers/editors
• Statistical programming
• Regulatory affairs
• Clinical development

Speakers

Gabriella Mangino, Product Manager, Synchrogenix Information Strategies, Inc., a Certara company

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.


Beth Miller, Safety Project Manager, Synchrogenix Information Strategies, Inc., a Certara company

Beth Miller has more than 15 years of regulatory and safety writing and project management experience in the pharmaceutical industry. Specialties include writing, editing, and managing safety narrative projects and other regulatory documents. As a Safety Project Manager at Synchrogenix, Dr. Miller is responsible for all aspects of project management for safety and narrative projects, including the development of strategies for organizing and preparing narratives and safety deliverables.