This session delves into the transformative digital efforts at regulatory bodies, with a case examination on the FDA's electronic Submission Template and Resource (eSTAR) program and how the integration of advanced digital platforms enable cross-functional teams to accelerate submission, registrations, and changes, while streamlining time to market. It discusses how the MedTech sector is navigating the new digital era, highlighting the role of these innovations in simplifying regulatory submissions, managing registrations, and automating change control processes. Through real-world examples, attendees will learn about the benefits of digital transformation in mitigating inefficiencies within regulatory affairs departments, improving cross-functional collaboration, accelerating market access, and improving regulatory workflow all while ensuring compliance. The session aims to equip MedTech professionals with insights into leveraging digital solutions for enhanced regulatory strategies and streamlined market entry.
Attendees will gain an in-depth understanding of the critical role digital transformation plays in modernizing regulatory compliance and streamlining submission processes in the MedTech industry. This session is paramount for regulatory, quality, and product management professionals seeking to harness the power of digital solutions for more efficient regulatory strategies.
Takeaways include:
- practical knowledge on implementing digital platforms to enhance team collaboration
- reduce submission errors
- significantly cut down time-to-market for innovative medical devices.