Co-Processed API

The Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. This center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore.

M-CERSI

The FDA and M-CERSI will host a public workshop from July 13-14, 2022.

University of Maryland School of Pharmacy

Pharmaceutical researchers, regulatory and materials scientists and manufacturing colleagues from industry, academia, and regulatory agencies are invited to attend a workshop on co-processed API on July 13 and 14, 2022, from 8:30 a.m. to 4:30 p.m. (EDT).The event will be held in person at the University of Maryland, Baltimore School of Pharmacy, located at 20 N. Pine St. Baltimore, MD 21202. However, a virtual option will be made available although on site attendance is encouraged to facilitate the discussion and networking (pending any changes due to a COVID-19 situation). A networking event will be planned in the evening after day 1 for those able to travel.This two-day workshop will examine recent advances in co-processed API as a technology to improve drug-substance physical-chemical properties and drug product manufacturing process robustness and explore proposals for enabling commercialization of these transformative technologies. Regulatory considerations will also be discussed with a focus on regulatory classification, regulatory CMC strategies and CMC documentation supporting the use of this class of materials for clinical studies and commercialization.FOR MORE INFORMATION:More information about this event is available at <a href="https://www.pharmacy.umaryland.edu/centers/cersievents/co-processed-api" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">https://www.pharmacy.umaryland.edu/centers/cersievents/co-processed-api</a><a href="https://www.pharmacy.umaryland.edu/centers/cersievents/api-excipient-co-processing/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer"></a><a href="https://www.pharmacy.umaryland.edu/centers/cersievents/biosimilars2022/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer"></a>

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Co-Processed API

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