From GMP compliance and data integrity to the behind-the-scenes role of the Qualified Person (QP), this session will focus on the practical decisions that keep trials moving forward or bring them to a halt. Jim Kernan and Aoife Kernan of PRNOAV Clinical will also explore the real challenges of cold-chain logistics, including maintaining -80°C conditions for biologics, validating ultra-low-temperature labeling, and managing risk across multiple partners and sites.
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