신약개발을 위한 GMP 계획, 운영, 문제 해결

신약개발 독성시험의 전략과 실제

전임상 ADMET 및 모델링

초기임상시험의 전략과 실제

후기임상시험의 전략과 실제

특강(연자TBD) 및 수료식

Registration

Opening : ´How to maximize value of products in early development?´

Congratulatory message:

1. Better Prepared to Move Early Phase Trials.
① Interpretation of non-clinical data for clinical development planning.
② How modeling helps FTIH – including CRM.

2. Implementation of Novel Clinical Trial Designs in Cancer Trials (I).
① Industry perspective.
② Investigators perspective.
③ Statistical consideration

3. Implementation of Novel Clinical Trial Designs in Cancer Trials (II).
(Ex)- "Expansion Cohorts", "Master Protocols", "Single-arm design", "Real-world evidence"

Registration

4. Understanding FDA Expedited Approvals for Effective Regulatory Strategy.

5. First in Human Design. : Strategy for efficient clinical development.

6. ´Case studies´ - Begin with the End in mind.