Global

Criticality of Openness in Deviation Investigations

Importance of Timely Closures of Deviations

ICH E8 Section 6 – Conduct, Safety, Monitoring and Reporting

Gene Therapy: Adeno-Associated Virus and Lentivirus Processing

Non-Clinical Protocol Design & Submission Process

Navigating Social Media Risks In Life Sciences

ICH E6 (R3) – What’s New

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

Cell Therapy (CAR T) Processing

Technology Transfer to GMP Manufacturing