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Bethesda North Marriott Hotel and Conference Center

Apr 23, 2019 7:00 AM - Apr 25, 2019 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

CMC Workshop

Explore how to utilize effective CMC strategies and execution and how it can help to reduce regulatory burden, enable shorter review timelines, and support post-approval maintenance.

Agenda

Day 1 Apr 23, 2019

3:15 PM — 4:45 PM

Session 2 Track A: Challenges with Lifecycle Management

Day 2 Apr 24, 2019

10:30 AM — 12:30 PM

Session 4 Track A: Patient-Centric Quality Standards

1:30 PM — 3:00 PM

Session 5 Track A: Accelerated Development – CMC Challenges and Best Practices

Day 3 Apr 25, 2019

8:00 AM — 10:00 AM

Session 7 Track A: Revision of ICHQ2 and ICHQ14: Analytical Procedure Development

10:30 AM — 12:00 PM

Session 8 Track A: QbD Incorporation in Large Molecule Development and Regulatory Filings

1:00 PM — 2:30 PM

Session 9 Track A: International CMC Topic

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CMC Workshop

Agenda

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