Advancing CMC Workshop

Accelerated pathways, EU CMC trends and global opportunities

Agenda

Day 1 Nov 25, 2019

9:30 AM — 10:45 AM

Registration and Welcome Coffee

10:45 AM — 11:00 AM

Welcome Remarks

11:00 AM — 1:00 PM

1:00 PM — 2:00 PM

Lunch

2:00 PM — 4:00 PM

Session 2: Opportunities for CMC in Accelerated Development Programmes Part 1

4:00 PM — 4:30 PM

Coffee break

4:30 PM — 5:30 PM

Session 3: Opportunities for CMC in Accelerated Development Programmes Part 2

5:30 PM — 6:30 PM

Networking Reception

Day 2 Nov 26, 2019

8:30 AM — 9:00 AM

Welcome Coffee

9:00 AM — 10:30 AM

Session 4: Preparing for the implementation of the EU Medical Devices Regulation

10:30 AM — 11:00 AM

Coffee Break

11:00 AM — 12:30 PM

Session 5: ICH Topics under Development Part 1

12:30 PM — 1:30 PM

Lunch

1:30 PM — 3:00 PM

Session 6: ICH Topics under Development Part 2

3:00 PM — 3:30 PM

Coffee Break

3:30 PM — 5:15 PM

Session 7: Reliance Programmes

5:15 PM — 5:30 PM

Closing Remarks

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