Agenda

Day 1 Sep 23, 2020

12:30 PM — 12:40 PM

Log-in and Connect

12:40 PM — 1:00 PM

Orientation and Introduction to the Advancing CMC Workshop

1:00 PM — 2:00 PM

Session 1: Enhanced Dialogue Learnings and Regulatory Agility in Times of Crisis

2:00 PM — 2:15 PM

Break

2:15 PM — 3:20 PM

Session 2, Part I: Agencies expectations/opportunities and Industry challenges and proposed outlook

3:20 PM — 3:30 PM

Break

3:30 PM — 4:40 PM

Session 2, Part II : Agencies expectations/opportunities and Industry challenges and proposed outlook

4:40 PM — 4:50 PM

Break

4:50 PM — 5:50 PM

Session 3: Progress of the EU-US cooperation on the Mutual Recognition Agreement for pharmaceutical Good Manufacturing Practices

5:50 PM — 6:00 PM

Wrap-up Day 1

Day 2 Sep 24, 2020

11:30 AM — 11:40 AM

Welcome

11:40 AM — 1:00 PM

Session 4: Catalysing the integration of science and technology in medicines development

1:00 PM — 1:15 PM

Break

1:15 PM — 2:40 PM

Session 5-6: Innovative Medicines and its CMC Regulatory Challenges

2:40 PM — 3:00 PM

Wrap-up of Day 2

3:00 PM — 4:00 PM

Speed Networking

Day 3 Sep 25, 2020

1:00 PM — 1:15 PM

Welcome

1:15 PM — 2:30 PM

Session 7: Medical Devices and Combination Products

2:30 PM — 2:45 PM

Break

2:45 PM — 4:05 PM

Session 8: ICH Q12 Implementation

4:05 PM — 4:20 PM

Break

4:20 PM — 5:10 PM

Session 9: Regulatory Convergence

5:10 PM — 5:30 PM

Wrap-up and Closing of the Workshop

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