We will share experience with Model Informed Drug Development (MIDD) Pilot Program over the past three years from the perspective of FDA and pharma industry experts including a discussion of key learnings, best practices, and impact on the development and regulatory strategy.

Document development for eCTD submission is a long and complex endeavor. The near-universally adopted method for document development, namely, the draft-review-revise process, is increasingly being questioned as best practice. This session will explore collaboration efforts and other options to improve the efficiency and quality of regulatory document authoring and editing.

Recent focus on inclusion, diversity, and patient engagement in drug development have led to a number of new innovations and regulatory requirements that impact pediatric patients - and the documentation companies must develop and provide.

There are significant benefits to using technology in the regulatory space from content creation through submission publishing. In this presentation, Synchrogenix regulatory experts will demonstrate the timesaving benefits of technologies that aid in the authoring of clinical study reports and patient narratives, as well as the review, validation and publishing of eCTD submissions. Highlighting specific past projects, we will share examples where we utilized these technologies for our clients.

Does your company get from database lock on the final clinical study to submission to a health authority in 3 months? 6 months? Longer? In this Content Hub, we'll discuss case studies to identify how to get your own duration closer to 3 months.