ASAP Regulatory Strategy: Acceptance and Feedback

ASAP Regulatory Strategy: Acceptance and Feedback

Elke Debie, Ph.D.
Manager, CMC Regulatory Affairs, Janssen Pharmaceuticals
Beerse, Belgium

During this presentation the use of ASAP stability in regulatory filings will be discussed. Companies have been utilizing ASAP tools to enable development.  However, the perception is that the application of these tools has been inconsistent across the industry. Therefore, from within the IQ consortium a working group was launched to focus on the use of ASAP to optimize pharmaceutical development. From within the regulatory sub-team a survey has been sent out to 17 pharmaceutical companies. The industry survey was conducted to get a sense of to what extent ASAP stability was used in regulatory filings along with the regulatory experience.   IQ consortium survey results will be shared during the presentation.