Medical Affairs and Scientific Communications Forum

The field of medical writing is always evolving, bringing both opportunities and challenges which directly impact our daily activities and strategic outlook. In this session, we will explore hot topics and trends in the industry today, many of which will be covered in more depth throughout the forum. One hot topic that continues to challenge the medical writing industry, especially as the industry strives to bring new therapies to the public faster, is accelerated timelines. One of the main pain points that authoring teams struggle with when faced with reduced cycle times, is the document review process. Developing and finalizing the documents required for clinical research and especially those required for regulatory marketing authorization can be a long and, sometimes, tortuous process owing to arduous rounds of review and revision that are not efficient or well-coordinated.

This session will focus on how to achieve good review practices and aims to give participants tools they can apply in their companies to improve their own review processes. It will look first at why we are getting the process wrong, and the main problems associated with document review and then address how to get it right. By presenting tools and techniques that can be employed to make these processes more effective, the presentation will make practical suggestions and propose educational ideas that participants can use to change the mindset of their teams.