Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.

Agenda

Day 1 Sep 27, 2022

8:30 AM — 9:00 AM Registration and welcome coffee
9:00 AM — 9:15 AM Welcome remarks and Introduction
9:15 AM — 10:30 AM Session 1, part I: Reliance & Work-sharing
10:30 AM — 10:50 AM Coffee Break
10:50 AM — 12:15 PM Session 1, part II: Reliance & Work-sharing
12:15 PM — 1:15 PM Lunch
1:15 PM — 2:45 PM Session 2: Lifecycle Management
2:45 PM — 3:05 PM Coffee break
3:05 PM — 4:30 PM Session 3: The future of CMC Submissions: Digital Data Dossier
4:30 PM — 4:50 PM Coffee Break
4:50 PM — 6:05 PM Session 4: Alternative Approaches to Accelerate Development
6:05 PM — 6:15 PM Wrap-up
8:00 PM — 10:00 PM Networking Dinner - Please register separately for the dinner.

Day 2 Sep 28, 2022

9:00 AM — 9:10 AM Welcome & Introduction
9:10 AM — 10:40 AM Session 5: Interactive Activity: How could CMC Lifecycle Management change in the future?
10:40 AM — 11:10 AM Coffee Break
11:10 AM — 12:10 PM Session 6: Growing Modalities & ATMPs CMC
12:10 PM — 1:10 PM Lunch break
1:10 PM — 2:40 PM Session 7: Quality Innovation
2:40 PM — 3:00 PM Wrap-up and Highlights

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+41 61 225 51 51

Accelerating CMC Workshop

Agenda

Day 1 Sep 27, 2022

Day 2 Sep 28, 2022

Contact us

Registration Questions?

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