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Artificial intelligence in pharmaceutical regulatory affairs.

Ruchika S Patil1, Samruddhi B Kulkarni1, Vinod L Gaikwad2

  • 1Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India.

Drug Discovery Today
|July 13, 2023
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Summary
This summary is machine-generated.

Artificial intelligence (AI) can simplify complex pharmaceutical regulatory affairs by automating tasks like dossier filling and quality management. This technology enhances efficiency and creates new opportunities for human-AI collaboration in the field.

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Area of Science:

  • Pharmaceutical science
  • Computer science
  • Regulatory affairs

Background:

  • Artificial intelligence (AI) involves computers performing tasks associated with human intelligence, such as learning and problem-solving.
  • Pharmaceutical regulatory affairs manage the complex processes of drug development and approval.
  • Integrating AI offers a potential solution to streamline regulatory procedures.

Purpose of the Study:

  • To explore the potential applications and impact of artificial intelligence in pharmaceutical regulatory affairs.
  • To identify how AI can simplify and automate regulatory processes.

Main Methods:

  • Review of current AI capabilities relevant to regulatory tasks.
  • Analysis of potential AI applications in administrative work, dossier submission, data extraction, auditing, regulation implementation, and quality management.
  • Discussion of human-AI interaction in regulatory contexts.

Main Results:

  • AI can automate numerous regulatory processes, including administrative tasks, dossier preparation, and quality management.
  • AI integration simplifies complexity and establishes process links, leading to more efficient regulatory systems.
  • Human-AI collaboration presents novel opportunities within pharmaceutical regulatory affairs.

Conclusions:

  • Artificial intelligence holds significant potential to revolutionize pharmaceutical regulatory affairs by increasing efficiency and reducing complexity.
  • AI-driven automation and enhanced human-AI interaction are key to optimizing future regulatory management.