Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact over the First Three Years
Patrick Smith |Senior Vice President, Integrated Drug Development Strategy
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.
The Trend Toward Collaborative Authoring: Pros and Cons Versus Fixed Steps for Document Development
Mark R Bowlby, PhD, |Director, Global Submissions
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.
Synchrogenix Innovation Theater: Medical Writing and Submission Compilation Made Easy - Technology Solutions from Regulatory Experts
Gabriella Mangino, Product Manager, Justin Savesky, Sr. Director, Regulatory Science Technology, Steve Sibley, Vice President, Global Submissions and Submissions Leadership |
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.
Steve Sibley |Vice President, Global Submissions and Submissions Leadership
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.