Regulatory Affairs in Biopharmaceuticals

Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such a program is broad, noted that it is necessary to break out of the mind-set that regulatory science resides totally with FDA and that the field's purpose is to create a workforce that will function within the FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process.

  • Biopharma Regulatory challenges
  • Regulatory Approvals for Biopharma drug products
  • Overview of drug, biologic and device regulatory pathways
  • Role of Regulatory Authorities
  • BPCI Act
  • Hatch-Waxman Act

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