1:45PM – 2:30PM
IMPLEMENT A RISK-BASED APPROACH FROM DEVELOPMENT THROUGH COMMERCIALIZATION
Emily S. D. Trubee, M.S., Stability Manager, R&D, ADARE PHARMACEUTICALS
Stability testing is an activity which is crucial in supporting both the development and the commercialization of pharmaceutical products. Depending on the phase, there are different study objectives as well as stability study requirements which need
to be addressed. Product development is accelerating, the pharmaceutical industry is becoming more global, and many companies are being asked to do more with fewer resources. Introducing a risk-based approach to the design and execution of product stability studies has become key, and understanding the risks and rewards of such designs is crucial.
By participating in this presentation, you will learn:
- The minimum requirements are for each type of study
- What region-specific requirements need to be considered?
- How can Quality Risk Management be used for stability studies?
- What are some examples of acceptable risk-based approaches
- How can stability data be used to leveraged to satisfy
- Examples of risk-based stability study designs
- Current industry trends for the acceptance of risked-based