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Regulatory Affairs Course

Thalidomide disaster, Elixir Sulfanilamide Incident and many other such instances demonstrated as a tragic lesson for developing stringent rules and regulations. Regulatory Affairs is a profession which has developed from the desire to protect public health, by controlling the safety and efficacy of healthcare products. It is involved throughout the lifecycle of a product i.e. from the synthesis of the active moiety to marketing to post approval activities. Most healthcare industries have specialist departments of Regulatory Affairs professionals.

Role of Regulatory Affairs Professional:

  • To keep track of the ever changing rule/guidance
  • Preparation and submission of Registration documents to various regulatory agencies
  • To give strategic and technical support to R&D, QA/QC, Production and Marketing departments etc.

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Regulatory Affairs

  • Diff. Regulatory bodies of diff. countries
  • Regulatory Challenges
  • Regulatory Affairs in India
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