FDA LEARNING OPPORTUNITY: Regulatory Education for Industry (REdI) Annual Conference 2023

 This 3 track FREE Conference has 3 tracks, small molecule drugs, biologics and devices. Registration and detailed agenda are available at the link.  

PLENARY

Federal law authorizes the FDA to collect user fees which help the FDA fulfill its mission of promoting and protecting the public health. Most major user fee programs run in five-year cycles, and the past year saw the launch of the current cycle for CDER, CBER, and CDRH. This session will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.

DRUGS TRACK

The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.

Topics Include

• New Meeting Types, including What's New Under PDUFA, BsUFA, and OMUFA
• PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates
• Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review

BIOLOGICS TRACK

The biologics track will focus on the developmental and regulatory topics relevant to advanced therapies, including cellular and gene therapies, tissue-engineered and other biological products. The speakers will present updates on programmatic enhancements mandated by PDUFA-VII, including new regulatory programs, stakeholder communications and much more.

Topics Include

• IND readiness: contents of preclinical and clinical parts; Expanded Access INDs
• Product development challenges and Chemistry, Manufacturing, and Controls (CMC) Developmental Readiness Pilot program
• Estimand and Complex Innovative Design (CID) Program in application to CBER biologics
  

   

  DEVICES TRACK

  The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

• Topics Include

• Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483
• Premarket Notification [510(k)] Program; Quality System Principles
• Tips and Best Practices for High Quality Regulatory Submissions