by GARR Staff
December 15, 2024
On May 30, 2024, the FDA Regulatory Education for Industry (REdI) Annual Conference 2024, was held at The Hotel@ the University of Maryland. The theme of the conference was Innovation in Medical Devices and the conference was tailored for professionals in the pharmaceutical, biotechnology, and medical device industries, as well as physicians, pharmacists, nurses and those just venturing into regulatory affairs.
The agenda included three tracks for participants to choose from which included a total of 42 sessions from a multitude of FDA Speakers and Senior Leadership officials. The sessions were designed to provide participants with a strong, foundation of FDA’s regulatory requirements in these product centers and to create awareness around current activities.
Even if you missed the live event, the conference recording and slides below offer a plethora of information and learning from the three major device centers within FDA listed below.
CDER (Drug Track) Recordings and Session Slides:
o Enhancing Clinical Trial Innovation
o AI in Drug Development
o Reimagining Clinical Research: The Transformation of Trial Design & Conduct
o Advanced Manufacturing Technologies (AMT) Designation Program
o Innovative Approaches to Emerging Threats
CDRH (Devices Track) Recordings and Session Slides:
o Regulatory Science Tools
o Premarket Notification [510(k)] Program
o Clinical Studies, including Investigational Device Exemptions
o Quality System Principles
o FDA Medical Device Inspections
CBER (Biologics Track) Recording and Session Slides:
o Regulatory submissions for cellular and gene therapy products & patient engagement
o Licensure of blood establishments
o Regulation of vaccine products
o Post-marketing evaluation of biological products
o Bioresearch Monitoring processes for CBER products