The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance
This workshop is sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).
New Dates Announced
April 30 - May 1, 2026
Postponed from the original date of March 11-12, 2025.
| Event Information | |
|---|---|
| Date: | April 30- May 1, 2026 |
| Time: | 8:30 a.m. - 5 p.m. |
| Location: | Universities at Shady Grove (Rockville, Md.), Building II |
About the Event
This two-day public workshop represents a transformative approach towards the role of dissolution testing in regulatory decision making, moving beyond traditional quality control paradigms toward a predictive, patient-centric science. The workshop will explore the importance of dissolution testing and its shift from a quality control test to strategic tool that ensures adequate clinical performance throughout changes in the drug product’s lifecycle.
The workshop centers on a comprehensive risk assessment framework that examines the interplay between API physicochemical properties, drug product attributes, and gastrointestinal physiological conditions. This framework ranks drug products from very low to very high risk based on how material attributes and formulation and manufacturing variables, along with gastrointestinal physiological conditions, influence in vivo drug dissolution and absorption into the systemic circulation. In this context, the risk level determines the appropriate dissolution testing strategy and regulatory requirements.
Participants will explore how this paradigm shift can improve product understanding, reduce regulatory burden, and assure consistent clinical performance of moderate- to high-risk drug products by aligning dissolution testing with actual patient outcomes rather than arbitrary specifications or process capabilities.
Draft Agenda - The Evolution of Biopharmaceutics