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Chungbuk C&V Center

Aug 21, 2019 8:00 AM - Aug 22, 2019 6:00 PM

Osong-Saengmyeong-1-ro, 194 , Osong-eup, Cheongju-si, , Chungbuk, 28160, Korea, Republic of

2019 DIA-NIFDS Workshop: Science Based Drug Development and Approval

Opportunities and Challenges in Drug Development and Approval for Small Molecules and Biologics

Agenda

Day 1 Aug 21, 2019

9:00 AM — 9:20 AM

Keynote Presentation 1- Clinical Trials in Korea : Current Status and Future Strategies

9:20 AM — 10:10 AM

Keynote 2 - Digital Transformation in Healthcare through AI

10:30 AM — 12:00 PM

Session 1: Strategy and Regulatory Science of Non-Clinical Development

1:00 PM — 3:15 PM

Session 2 : Orphan Drug development and Approval in Regulatory Perspective

3:30 PM — 5:45 PM

Session 3: Impact of PK-PD Modelling and Simulation on Drug Development and Approval

Day 2 Aug 22, 2019

9:00 AM — 9:20 AM

Keynote 3: Present and Future Strategies for Biopharmaceuticals in Korea

9:20 AM — 10:50 AM

Session 4: Current Trends in Cell and Gene Therapy Products from Regulatory Perspective

11:05 AM — 12:35 PM

Session 5: Biologics - Innovation and Challenges from CMC Perspective

1:30 PM — 3:00 PM

Session 6: Non-clinical Safety Evaluation of Advanced Therapies

3:00 PM — 5:30 PM

Session 7: Strategies for Global Drug Development

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