In this session, experts will discuss patient centric approaches to drug development, focusing in on applications to product quality. The session will start with a broad discussion of patient centric development strategies and subsequently narrow in on how these ideas can be applied to ensure drug quality. The development of patient centric or clinically relevant specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and the lifecycle of a pharmaceutical product. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of clinical/marketing application, significant benefits can be gained for both regulatory agencies and industry.
The session will cover the application of patient centric specifications and discuss how revisions to ICH Q6A/B could embrace these ideas. Wider adoption of these principles could form the cornerstone to achieving global regulatory harmonization, reducing the complexity of managing a product through its lifecycle, reducing environmental impact from our pharmaceutical processes, improving supply chain robustness, and potentially minimizing drug shortage and disruption of supply of medicines to patients.