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Boston Convention and Exhibition Center

24 jun 2018 8:30 a.m. - 28 jun 2018 12:00 p.m.

415 Summer Street, , Boston, MA 02210 , USA

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Agenda

Día 1 25 jun 2018

11:00 AM — 12:15 PM

FDA Innovation in Pharmaceutical Quality Assessment and Inspection

3:00 PM — 4:15 PM

New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges

Día 2 26 jun 2018

8:00 AM — 9:15 AM

CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs

10:30 AM — 11:45 AM

Biosimilars: Demonstrating Structural and Functional Similarity

2:00 PM — 3:15 PM

ICH M9 BCS-Based Biowaivers

4:15 PM — 5:30 PM

ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?

Día 3 27 jun 2018

8:00 AM — 9:15 AM

Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes

2:00 PM — 3:15 PM

Modernization and Harmonization of Inspectional Approaches

4:00 PM — 5:15 PM

Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence

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