Assistant Professor Department of Regulatory & Quality Sciences USC School of Pharmacy
Description: As pharmaceutical companies change their business models to remain competitive, they seek ways to reduce the costs and risks associated with drug development. Outsourcing to contract research and manufacturing organizations can reduce the costs of clinical trials and manufacturing but may result in a patchwork of vendors that is difficult to integrate. Integration can be simplified by entering into more comprehensive “preferred” partnerships with service providers and agreements with other companies or academic organizations, but these complicate the business model by adding new legal and operational requirements. As with the development of manufacturing, quality, laboratory testing and clinical trial agreements, a standalone regulatory agreement has the potential to clarify the relationships and responsibilities between partners working jointly on a single regulated product. Participants can consider how such agreements might be created for different types of partnering activities and made available for use throughout the industry.
Learning Objectives:
Debate the need for Regulatory Agreements
Identify elements that would contribute to a regulatory agreement template
Determine the usefulness of regulatory agreements for their company's alliances within the medical product community