The intriguing topic of clinical trial quality and compliance continues to evolve in clinical operations, based on discussions at ExL’s 9th 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 9th 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….
