CMC Workshop: From Drug Development to Global Supply to Patients

Pharmacopeias are recognized sources of public standards for pharmaceutical products, ingredients, components, and agreed common practices. Compendial standards are typically comprised of test procedures and associated acceptance criteria. These standards are enforced by regulatory agencies, and are quality standards to be met by all manufacturers/applicants for certain territories. Companies that wish to market products globally must have a robust strategy for meeting compendial requirements for each market. Collaboration between regulators, industry, and pharmacopeias is crucial to ensure that these standards serve to benefit public health, both regionally and internationally. This session will provide an overview of the United States and European compendial science activities. The industry presentation will share experiences in managing public standard implementation globally. Panel discussion will allow participants to have deeper interactions with the speakers and the fellow participants.