The U.S. Food and Drug Administration and the Product Quality Research Institute (PQRI) are hosting the 4th FDA/PQRI Conference on Advancing Product Quality workshop April 9-11, 2019, in Rockville, MD. The conference brings together regulatory, industry and academic leaders to discuss critical topics in drug product delivery design, development, and manufacture.
After morning plenary sessions, attendees will break out into themed tracks:
- Biopharmaceutics: Novel Approaches to Improve Treatment Outcome and Patient Safety
- Development: Emerging Technologies and Patient Centricity in Early Drug Development
- Manufacturing: Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products
On the third day of the conference, FDA will present its latest initiative, Knowledge-aided Assessment and Structured Application (KASA). This is a creative regulatory approach to modernize the quality assessment and enhance the drug application submission format. The initiative will be outlined by an FDA panel moderated by Dr. Lawrence Yu, Deputy Director of CDER’s Office of Pharmaceutical Quality. Presenters will include CDER’s Dr. Susan Rosencrance and other agency experts.
Altogether, more than 20 FDA representatives from the agency’s Office of Pharmaceutical Quality (OPQ), Office of Generic Drugs (OGD), and Office of Translational Sciences (OTS) will speak at the conference.
For more information on this conference, please visit FDA’s Meetings, Conferences & Workshops (Drugs) page. Online registration closes March 29.
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