A Review on various aspects of Regulatory Affairs

  • Swaranjali Pore Adarsh College of Pharmacy, Shivaji University Kolhapur, near MIDC Khambale, Vita 415311, Maharashtra, India
  • Jeevan Deshmukh Student
  • Shivani Biskite
  • Snehal Jadhav
  • Akshata Moharekar
  • Ankita Gurav
DOI https://doi.org/10.22270/ijdra.v12i2.664

Abstract

In order to guarantee the efficacy, safety, and calibre of medications, medical equipment, and other healthcare supplies, Regulatory Affairs is essential. Anticipating future trends and difficulties in Regulatory Affairs is crucial as the healthcare sector changes due to technological breakthroughs, globalization, and new regulatory paradigms. This abstract examines the consequences of developing fields for regulatory frameworks, including gene treatments, digital health, artificial intelligence, and personalized medicine. It also covers the increased significance of real-world evidence, patient-centric approaches, and international harmonization in regulatory decision-making. In addition, it looks at the difficulties presented by supply chain interruptions, cybersecurity risks, and regulatory divergence in a world that is changing quickly. Stakeholders may effectively navigate the complicated regulatory landscape of the future by embracing innovation, collaboration, and adaptive regulatory methods facilitate the timely delivery of safe and effective healthcare products to patients worldwide.

Keywords: Efficacy, Regulatory Affairs, Globalization, Artificial Intelligence, Stakeholder, Innovation

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How to Cite
Pore, S., Jeevan Deshmukh, S. Biskite, S. Jadhav, A. Moharekar, and A. Gurav. “A Review on Various Aspects of Regulatory Affairs”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 15-22, doi:10.22270/ijdra.v12i2.664.
Issue
Vol 12 No 2 (2024): VOLUME 12, ISSUE 2, 2024
Section
Review
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