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The IND Journey: First-In-Human (FIH) Clinical Trial
*การอบรมนี้มีการบันทึกภาพและเสียง เพื่อใช้เป็นสื่อการสอนภายในมหาวิทยาลัยมหิดล
Agenda
July 5th, 2022 How To Ensure The Successful Of FIH Clinical Trials
08:45-09:00 Welcome Speech And Introduction
09:00-09:40 Challenges Of FIH Clinical Trials In Thailand
09:40-10:20 Thai FDA Phase I Accreditation Guidance
10:20-10:35 Refreshment
10:35-11:15 IRB Review Of FIH Clinical Trial: Siriraj IRB Perspective
11:15-11:45 FIH Clinical Trial Management: Investigator’s Experience
11:45-12:15 Ask The Experts

July 6th, 2022 FIH Clinical Trial: Sharing Experience From The National Cancer Center Hospital, Japan
13:00 – 13:10 Welcome Speech And Introduction
13:10 – 13:40 Phase I and FIH At NCCH
13:40 – 14:15 IRB Process At NCC
14:15 – 14:45 Perspective from CRC: Preparation And Management Of FIH
14:45 – 15:00 Q&A
Jul 5, 2022 08:30 AM
Jul 6, 2022 01:00 PM
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