Deviations that may affect patient safety in clinical trials are classified by the U.S. Food and Drug Administration and European Medicines Agency as important deviations or serious breaches, potentially leading to inspections and public disclosure. This highlights the need for research pharmacies to maintain strong quality management systems and optimize processes so they can focus on the most critical aspects of investigational product management without being burdened by unnecessary tasks. Efficient quality processes, supported by digital approaches to investigational product management, can play an important role in strengthening patient safety.

This panel session will explore practical site-level strategies, including quality process roadmaps for research pharmacies, regulatory perspectives, real-world examples of digitalized investigational product management, and pharmacist insights on implementing improved processes in practice.

CEU: 1.0 ACRP

Speakers:

• Hubert Lesur, ACRP-CP, CCRC, Clinical QA Consultant, GCP Auditor, Founder, HL Health Support

• Christina Shin, PharmD, Research Pharmacy Manager, UCLA Health

• Mindy Suttlemyre, BS, PhT, Director of Customer Success, McCreadie Group