DIA 2018 Global Annual Meeting

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

アジェンダ

Day 1 2018年6月25日 (月)

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

Day 2 2018年6月26日 (火)

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?

Day 3 2018年6月27日 (水)

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