The goal of this workshop is to discuss challenges, issues, and concerns for two FDA guidance documents that are most important to AAPS members.
Day 1: Quality Considerations for Continuous Manufacturing
Draft guidance for industry, February 2019
Day 2: In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies
Draft guidance for industry, October 2017
Both days will feature plenary speakers and have breakout-style sessions on several topics. This format will provide ample opportunity for participants to engage in open dialogue with regulators, academia and industry scientists, with the goal of providing insight into the guidance for submission of regulatory applications.