ABSTRACT
This chapter addresses how knowledge management (KM) intersects with the regulatory challenges and how the process could evolve to allow KM's potential to be realized for the benefit of industry, regulators, and most importantly, the patient. In 2008, the International Conference on Harmonization (ICH) released a guideline addressing the current regulatory expectations for a modern Pharmaceutical Quality System (PQS), which more formally placed the concept of KM in the regulatory equation. KM practices vary widely from company-to-company, and indeed even within a given company, across the product lifecycle. Industry and regulators are wrestling with what the knowledge flow should look like across a product lifecycle, at pharma companies internally, and with suppliers, contractors, and regulatory agencies. Regulators are sending a clear message to industry at public forums that the open flow of knowledge is essential to having a viable regulatory process that can facilitate product clearance and continuous process improvement.
