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  1. News & Events for Human Drugs

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

The drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts will provide insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.

TOPICS INCLUDE

  • Enhancing Clinical Trial Innovation
  • AI in Drug Development
  • Reimagining Clinical Research: The Transformation of Trial Design & Conduct
  • Advanced Manufacturing Technologies (AMT) Designation Program
  • Innovative Approaches to Emerging Threats

INTENDED AUDIENCE

  • Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
  • Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
  • Industry professionals at all levels of expertise

FDA RESOURCES

 
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