CDEROne Data Lakehouse 可实现高效的人工智能和数据治理.pdf

1、CDERONE DATA LAKEHOUSE FOR EFFICIENT AI&DATA GOVERNANCE1CDER Office of Business Informatics:Ethan Chen,CDER Director Division of Data ManagementVenu Boppana,CDER Strategy&Innovation LeaderDatabricks AI SummitJune 10-13,2024The views and opinions presented here represent those of the speaker and shou

2、ld not be considered to represent advice or guidance on behalf of the U.S.Food and Drug AdministrationAGENDAAGENDAFDA CDER at a GlanceFDA CDER at a GlanceWhat is CDEROne?What is CDEROne?CDEROne AICDEROne AI123Moving ForwardMoving Forward4CDEROne Analytics:FDA CDER at a GlanceFDA at a Glance520%of U.

3、S.consumer spending is on products that FDA regulatesFOOD DRUGSOver-the-counter and prescription drugs,including biological therapeutics and generic drugsBIOLOGICAL PRODUCTSMEDICAL DEVICESCOSMETICSTOBACCO ANIMAL HEALTHINSPECTION&ENFORCEMENTCDERs Mission6POST-MARKET SURVEILLANCEQUALITYCOMPLIANCEPRE-M

4、ARKET APPROVALSUPPLY CHAINCenter for Drug Evaluation and Researchis to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use,that they meet established quality standards,and that they are available to patients.The Executive Order establ

5、ishes a governmentgovernment-wide effort wide effort to guide responsible AI development and deployment responsible AI development and deployment through federal agency leadership,regulation of industry,and engagement with international partnersIt includes 8 requirements 8 requirements for HHSfor HH

6、S,with specific language related to drugs and devices regulations.Advancing CDERs AI Maturity7DIRECTIVESINDUSTRY TRENDCDER STRATEGIC GOALExecutive Order on AI,PDUFA,GDUFA commitmentsCDER must modernize to keep pace with rapidly advancing industry trends in AI spaceCommissioner Califf has emphasized