Regulatory Sciences

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, Drug toxicity and efficacy, quality, and performance of all FDA-regulated products. An approach to developing the programs in regulatory science that leverages what has been learned 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 an program is broad, noted that it is necessary to break out of the mindset that regulatory science resides totally with FDA and that the field's obligation is to create a workforce that will function within the confines of FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program include understanding research and scientific methodology, pharmacology, toxicology therapeutics, and the science that underpins the regulatory process.

  • Regulatory compliance & requirements for drugs & biologics
  • Good maufacturing practise
  • Good documentation process
  • Consideration of bioethics

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