Regulatory Insights: Navigating FDA's Advanced Manufacturing Engagement Landscape: Programs and Practical Insights
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
Learn how industry can effectively engage with the US FDA on advanced manufacturing technologies, including an overview of key US FDA/ CDER programs such as the Emerging Technology Program (ETP), Advanced Manufacturing Technologies Designation Program (AMTDP), Framework for Regulatory Advanced Manufacturing Evaluation (FRAME), to foster dialogue with the FDA and drive innovation. Attendees will receive real-life examples from the industry perspective and gain practical insights into aligning internal teams with FDA expectations throughout the manufacturing lifecycle.
Join us for the first episode of ISPE's Regulatory Insights. This new virtual series will bring together regulators and industry leaders to unpack the latest trends, policies, and signals shaping today's global regulatory landscape. This power-packed session will spotlight game-changing US FDA/CDER initiatives, including the Emerging Technology Program (ETP), the Advanced Manufacturing Technologies Designation Program (AMTDP), and the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME). Uncover opportunities that can fuel your research and arm you with winning strategies to achieve early US FDA engagement, de-risking regulatory submissions, and on-site inspections. Walk away with actionable strategies for navigating US FDA expectations throughout the manufacturing lifecycle.
Learning Objectives
A candid, expert-led conversation designed to give you:
- Direct perspectives from regulatory authorities on today's most pressing issues
- Early signals on emerging guidance and agency priorities
- A live Q&A where your questions get real answers
