Yes

ICH E8 Section 5 – Design Elements and Data Sources for Clinical Studies

Cell Therapy (CAR T) Processing

Technology Transfer to GMP Manufacturing

Gene Therapy: Applications of Adeno-associated Viruses and Adenoviruses

Deviation – Investigator

Root Cause Analysis

Test Systems, Test Articles, and Safety Endpoints in GLP Protocols

Deviation – Initiator

Serious Breaches

ICH E8 Section 4 – Drug Development Planning