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Chapter 10 Regulatory affairs and compliance in the pharmaceutical sector

  • Rishabha Malviya , Shristy Verma , Sonali Sundram and Harshil Shah
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Abstract

The pharmaceutical sector is accountable for guaranteeing the safety, efficacy, and quality of therapeutic products. Attaining worldwide competitiveness in pharmaceutical manufacturing requires rigorous adherence to ongoing quality, environmental protection, occupational health, and safety standards. The study analyzes the recommendations and effective implementation strategies of the United States Food and Drug Administration. The objective of the chapter is to deliver an exhaustive overview of US regulatory compliance, emphasizing US FDA rules. Artificial intelligence (AI) is an advanced technical instrument that is significantly transforming several GMP sectors. AI systems can understand complex regulatory documents, therefore aiding pharmaceutical companies in staying abreast of the continually evolving compliance demands for medication research and approval. The application of AI extends to crucial areas such as compliance with packaging and labeling, significantly improving the efficiency and accuracy of regulatory affairs.

Abstract

The pharmaceutical sector is accountable for guaranteeing the safety, efficacy, and quality of therapeutic products. Attaining worldwide competitiveness in pharmaceutical manufacturing requires rigorous adherence to ongoing quality, environmental protection, occupational health, and safety standards. The study analyzes the recommendations and effective implementation strategies of the United States Food and Drug Administration. The objective of the chapter is to deliver an exhaustive overview of US regulatory compliance, emphasizing US FDA rules. Artificial intelligence (AI) is an advanced technical instrument that is significantly transforming several GMP sectors. AI systems can understand complex regulatory documents, therefore aiding pharmaceutical companies in staying abreast of the continually evolving compliance demands for medication research and approval. The application of AI extends to crucial areas such as compliance with packaging and labeling, significantly improving the efficiency and accuracy of regulatory affairs.

Chapters in this book

  1. Frontmatter I
  2. Preface V
  3. Foreword VII
  4. Contents IX
  5. Chapter 1 Introduction to smart pharma: foundation of AI and big data 1
  6. Chapter 2 Emerging technology in pharma and the role of AI and blockchain 19
  7. Chapter 3 Partnership and collaboration in the pharmaceutical industry 37
  8. Chapter 4 Education and training in smart pharma 55
  9. Chapter 5 Drug manufacturing and quality control with artificial intelligence 77
  10. Chapter 6 Drug development and clinical trial via artificial intelligence 97
  11. Chapter 7 AI-driven clinical decision support systems for pharma executives 121
  12. Chapter 8 AI-based pharmacovigilance and drug safety 143
  13. Chapter 9 Intellectual property and data privacy in the pharmaceutical sector 163
  14. Chapter 10 Regulatory affairs and compliance in the pharmaceutical sector 183
  15. Chapter 11 AI and big data in post-marketing surveillance 201
  16. Chapter 12 Challenges and ethical considerations 219
  17. Chapter 13 Future trends and innovations of AI in healthcare 237
  18. Index 253
https://doi.org/10.1515/9783111574288-010

Chapters in this book

  1. Frontmatter I
  2. Preface V
  3. Foreword VII
  4. Contents IX
  5. Chapter 1 Introduction to smart pharma: foundation of AI and big data 1
  6. Chapter 2 Emerging technology in pharma and the role of AI and blockchain 19
  7. Chapter 3 Partnership and collaboration in the pharmaceutical industry 37
  8. Chapter 4 Education and training in smart pharma 55
  9. Chapter 5 Drug manufacturing and quality control with artificial intelligence 77
  10. Chapter 6 Drug development and clinical trial via artificial intelligence 97
  11. Chapter 7 AI-driven clinical decision support systems for pharma executives 121
  12. Chapter 8 AI-based pharmacovigilance and drug safety 143
  13. Chapter 9 Intellectual property and data privacy in the pharmaceutical sector 163
  14. Chapter 10 Regulatory affairs and compliance in the pharmaceutical sector 183
  15. Chapter 11 AI and big data in post-marketing surveillance 201
  16. Chapter 12 Challenges and ethical considerations 219
  17. Chapter 13 Future trends and innovations of AI in healthcare 237
  18. Index 253
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