CRS Workshop on Mitigating Risks for Patients When Developing Oral Controlled Release Dosage Forms

The focus will be to understand the possible risks to patients and approaches to manage them when developing oral extended-release (ER) dosage forms. The discussion will relate to the design, development, and manufacture of commonly used ER systems. Industry leaders and subject matter experts will provide scientific basis to the material science, formulation, and process attributes that will help to mitigate risks, under the umbrella of Quality-by-Design. The overall goals of such approaches are to improve quality, reduce costs, but maintain patient safety and treatment.