Welcome!

Midwest Regional Forum Virtual Meeting
Wednesday and Thursday, September 9 - 10, 2020
Start Time: 10 am Central Daylight Time

Clinical (and Beyond) In-use Stability Studies – Challenges, Considerations and Case Studies

Clinical in-use stability studies are required for any new parenteral drug product, whether submitting the first IND/IMPD or filing the marketing authorization application. These studies are vital to our clinicians in the field as the studies determine the compatibility with common medical ancillaries, define storage conditions of the prepared product and demonstrate that our medicines are stable throughout the preparation and administration to our patients. This forum covers:

1. Considerations for designing phase appropriate compatibility and in-use studies

2. Microbial considerations for extemporaneous dose preparations for parenteral products

3. Analytical considerations for clinical in-use stability studies – what are the phase appropriate tests to perform

4. Analytical method challenges for low concentration in-use samples and case studies on how to overcome these challenges 

The CASSS Midwest Regional Forum is committed to bringing job-relevant education to our regional biopharmaceutical and biotechnology community through presentations, panel discussions, case studies and peer-to-peer learning. This year circumstances have forced us to pivot to virtual. We invite you to join us from where ever you are. 

Co-Chairs: Julie Heflin, AbbVie Inc. and Thomas Schomogy, Pfizer. Inc.