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4th DIA Cell and Gene Therapy Products Symposium in Japan

Agenda

Day 1 Dec 16, 2019

10:00 AM — 10:30 AM REGISTRATION
10:30 AM — 10:45 AM WELCOME AND OPENING REMARKS
10:45 AM — 11:15 AM EDUCATIONAL LECTURE
11:15 AM — 12:00 PM KEYNOTE ADDRESS 1
1:30 PM — 2:10 PM SESSION 1 - Japanese Standards for Biological Raw Materials in the Development of Regenerative Medical Products: From Industry Viewpoints
2:10 PM — 3:30 PM SESSION 2 - Concept of Comparability in Cell and Gene Products
4:00 PM — 4:45 PM KEYNOTE ADDRESS 2
4:45 PM — 5:25 PM SESSION 2 - PANEL DISCUSSION
5:30 PM — 7:00 PM NETWORKING RECEPTION

Day 2 Dec 17, 2019

8:30 AM — 9:00 AM REGISTRATION
9:00 AM — 9:10 AM OPENING - DAY 2
9:10 AM — 11:20 AM SESSION 3 - Correspondence to Cartagena Law – Operation for Type 1 Use Regulations and Evaluation of Any Risks from Environmental Impact
11:50 AM — 12:40 PM KEYNOTE ADDRESS 3
2:10 PM — 3:40 PM SESSION 4 - Regulatory Dialog in US, EU and Japan; Risk Balance on Pre/post-market to Treated Patients as Gene Therapy
4:10 PM — 5:30 PM SESSION 5 - Data Collection and Utilization for Gene Therapy Products after Launch
5:30 PM — 5:40 PM CLOSING REMARKS

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