Podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials

AI is increasingly being integrated across various industries, demonstrating its versatility and potential. In the biotech sector, it is important to consider how the use of AI might impact integral factors such as GCP compliance and inspection readiness. The incorporation of AI in the clinical trial process brings about a transformative influence on GCP compliance […]

Evolving Advisory Committee Processes: Key Updates From ODAC

By Nadine Bouchard (VP, Regulatory Affairs, Head of Program Management) and Lisa Sanders, PhD (Sr. Director, Regulatory Affairs)  Background To help in their decision-making, the US Food and Drug Administration (FDA) sometimes makes use of an Advisory Committee, as defined in various regulations. An Advisory Committee provides independent expert advice and makes non-binding recommendations to […]