이번  “EDGE”에서는  “Redefining Bladder Cancer Therapy: The Anktiva BLA Story” 라는 주제로 문한림 대표님이 직접 강의해 주시겠습니다.    

* 이번 강의와 QnA는 모두 라이브로 진행*

1. [FDA] Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry | FDA (Final, 3/1/2025)

2. [FDA] Q2(R2) Validation of Analytical Procedures | FDA (Final, 3/6/2025)

3. [FDA] Q14 Analytical Procedure Development | FDA (Final, 3/7/2025)

4. [FDA] Early Alzheimer’s Disease: Developing Drugs for Treatment | FDA (Draft, 3/12/2025)

5. [FDA] Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products | FDA (Draft, 3/13/2025)

6. [FDA] E2D(R1) Post-Approval Safety Data: Definitons and Standards for Managment and Reporting of Individual Case Safety Reports (Draft, 3/13/2025)

7. [FDA] Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products | FDA (Draft, 3/13/2025)

8. [FDA] Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples | FDA (Draft, 3/27/2025)

1. [EMA] Guideline on the quality aspects of mRNA vaccines | European Medicines Agency (EMA) 

2. [EMA] Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials | European Medicines Agency (EMA) 

3. [EMA] Guidance on the application of the amended Variations Regulation from 1 January 2025 | European Medicines Agency (EMA)

5. [EMA] PRAC recommendations on signals adopted at the 10-13 March 2025 PRAC meeting | European Medicines Agency (EMA)

6. [EMA] CTIS newsflash - 25 March 2025 | European Medicines Agency (EMA)