Learning Tracks

Data Exchange Platforms – Future of Regulatory Interactions and Submissions

Tuesday, October 3, 2023

11:00 a.m. - 12:00 p.m.

In this session, panel participants will share their perspectives on considerations around global collaboration and reliance regarding digital advancements and how this can impact generic and biosimilar manufacturers. Panelists will share their thoughts on current challenges and successes when it comes to collaborative approaches and technological solutions. The presentation also will cover Accumulus Synergy and the progress they have made in the digital transformation space around global real-time collaboration, flexible content ingestion, dynamic regulatory insights, and di-directional information exchange. This session is a unique opportunity to hear the progress Accumulus Synergy has made, learn what’s next, and offer your input on the next phase of this cutting-edge development in the world of regulatory submissions.


Ashley Jones-Mitchell
Director of Regulatory Innovation Strategy and Policy North America, Accumulus Synergy

Anand Saxena, M.Sc
Director – Regulatory Affairs, Cipla Ltd.

Brian Malkin, JD, MS
Associate General Counsel – Regulatory Law, Teva Pharmaceutical Industries