SBIA | FDA NanoDay Symposium 2022

Registration is now open!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance (SBIA) CONFERENCE FDA NanoDay Symposium 2022 October 11, 2022 | 8:50 AM - 3:10 PM Eastern This event is free. Register Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. FDA speakers will present reviewer perspectives on drug development and laboratory efforts to facilitate further understanding of challenges to manufacture products that contain nanomaterials. Two additional speakers will address safety evaluations of foods to contact surfaces that contain nanomaterials and the development of standard materials and methods for nanomaterials. FDA will discuss the primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials FDA will provide case studies on the development of the COVID mRNA lipid nanoparticle vaccine products FDA will present efforts to establish standards and standard methods for monitoring products that contain nanomaterials TOPICS COVERED An overview and discussion of the recently finalized "Guidance to Industry: Drug Products, Including Biological Products, that Contain Nanomaterials" A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products A nonclinical perspective of developmental challenges of products that contain nanomaterials The development of regulatory standards and methods for controlling products that contain nanomaterials INTENDED AUDIENCE Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials Foreign regulators who review comparable pharmaceutical products that contain nanomaterials CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event. This course has been: pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material TECHNICAL INFORMATION To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser. Please contact info@sbiaevents.com for all technical questions If you encounter any technical issues before or during the event, please visit the Technical Issues Support Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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