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Regulatory Affairs

Regulatory Affairs:Navigating the regulatory requirements and obtaining approvals from health authorities (e.g., FDA, EMA) for clinical trials and drug marketing.
Regulatory affairs in drug discovery refers to the specialized field responsible for navigating the complex regulatory requirements imposed by government agencies during the development and approval of pharmaceutical products. Here are some key aspects and considerations

  •     Regulatory Framework
  •     Early Development
  •     Preclinical Studies
  •     Clinical Trials
  •     Regulatory Submissions 
  •     Data Management
     
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