Clinical Trial Quality and Compliance Update

The intriguing topic of clinical trial quality and compliance continues to evolve in clinical operations, based on discussions at ExL’s 9^th Proactive GCP Compliance Conference. The biopharmaceutical industry is starting to act on implementing the ICH-E6 R2 guideline, experts discuss the importance of culture and how it influences compliance, and seasoned industry professionals elaborated on their experiences with inspection readiness. ExL’s 9^th Clinical Quality Oversight Forum is occurring in Philadelphia October 10-12, 2018.

Risk Management Evolution After ICH-E6 R2

Jonathan Rowe, Executive Director and head of Clinical Development Quality Performance and Risk Management at Pfizer, discussed the evolution of clinical trial risk management prior to and post ICH-E6 R2….