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Regulatory Education for Industry (REdI) Annual Conference 2024: Biologics Track

The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. The speakers will present updates on recent programmatic enhancements and initiatives from CBER product offices, including new regulatory programs and stakeholder communications, recent guidance documents, and highlights in the areas of innovation within the fields of biological product development. Regulatory considerations and practical recommendations will be provided by speakers experienced in product application review.

TOPICS INCLUDE

  • Regulatory submissions for cellular and gene therapy products and patient engagement
  • Licensure of blood establishments
  • Regulation of vaccine products
  • Post-marketing evaluation of biological products
  • Bioresearch Monitoring processes for CBER products

INTENDED AUDIENCE

  • Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
  • Regulatory affairs and other professionals working with submissions of INDs, IDEs, and BLAs to the Center for Biologics Evaluation and Research
  • Industry and consulting professionals working with advanced therapies, blood and vaccine products, and devices used with biological products

FDA RESOURCES

 
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