Presenter: Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ

Description: This session, part of a long-running and popular annual Convergence series, will feature experts in regulatory policy and intelligence who will provide the audience with in-depth, specific and verifiable information about what the FDA is expected to do next year related to pharmaceuticals, biopharmaceuticals, cell and gene therapy, over-the-counter drugs, and generic drugs.

This lively, fast-paced and forward-looking session will provide session attendees with actionable information they can use to prepare for upcoming regulatory changes, understand how seemingly unrelated regulatory changes will intersect, identify catalyst events which may affect how the FDA regulates, and understand the priorities of key regulatory staff.

Learning Objectives: Understand what the FDA is planning to do in 2025 and how that will affect attendees’ product development strategies; Identify areas of potential uncertainty that could affect the regulatory outlook for 2025, including the development of new policies and regulations, and how best to communicate that uncertainty.