2022 NIFDS -DIA Conference : New Logics of High-Tech Drug Development and Quality Challenges

Agenda

Day 1 Nov 17, 2022

9:30 AM — 10:30 AM

Registration

10:30 AM — 10:40 AM

Welcome Remarks

10:40 AM — 11:00 AM

Keynote - Director General, MFDS

11:00 AM — 1:00 PM

Session 1: Quality Control Through Technological Advancement

1:00 PM — 2:00 PM

Lunch

2:00 PM — 3:00 PM

Session 2: Development Strategy Of Complex Generics

3:00 PM — 3:15 PM

Tea/Coffee Break

3:15 PM — 4:15 PM

Session 2: Development Strategy of Complex Generics

4:15 PM — 4:20 PM

Closing Remarks

Day 2 Nov 18, 2022

9:00 AM — 9:05 AM

Welcome

9:05 AM — 10:55 AM

Session 3: Innovative Approaches And Quantitative Sciences In Drug Development

10:55 AM — 11:10 AM

Coffee/Tea Break

11:10 AM — 12:30 PM

Session 3: Innovative Approaches and Quantitative Sciences in Drug Development

12:30 PM — 1:15 PM

Lunch

1:15 PM — 3:45 PM

Session 4: Townhall PMDA & MFDS- Using RWD/RWE in the Life Cycle of a Drug - Japan, Korea

3:40 PM — 4:00 PM

Tea/ Coffee Break

4:00 PM — 5:50 PM

Session 5: Townhall FDA & EMA - RWE/RWD Regulatory Update and Case Study

5:50 PM — 6:00 PM

Closing Remarks

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