AI-Driven Innovations in Healthcare: Improving Diagnostics and Patient Care

Authors

  • Sudheer Kumar Kothuru Author

Abstract

The successful launch of a new drug in the pharmaceutical industry hinges not only on scientific advancements but also on navigating the intricate landscape of regulatory compliance. This research paper delves into the critical aspect of licensing requirements associated with introducing a new drug to the market and evaluates the preparedness of Enterprise Resource Planning (ERP) systems to address these regulatory demands. By examining the regulatory frameworks governing pharmaceutical licenses and leveraging insights from industry practices, the study aims to identify the key licenses essential for a new drug launch. Simultaneously, it assesses the capability of ERP systems in streamlining and ensuring compliance with these requirements. Every time  a new drug is introduced in the market, there will be certain licenses to be obtained and assigned to the master data. At Master Data Level, below licenses are required,

Downloads

Download data is not yet available.

References

Gibson, A., Johnson, P., & Smith, R. (2018). Manufacturing Licenses and Good Manufacturing Practices in the Pharmaceutical Industry. Journal of Pharmaceutical Quality Assurance, 15(2), 87-102.

Rossi, M., & Stonier, J. (2018). Navigating Marketing Authorizations: A Global Perspective. Regulatory Affairs Journal, 25(4), 231-246.

Chen, L., Wang, S., & Kumar, V. (2016). ERP Systems in Pharmaceutical Compliance: A Comprehensive Review. Journal of Enterprise Information Management, 29(1), 45-62.

Fernandez-Molina, C., Lopez-Cuadrado, T., & Lopez-Gonzalez, L. (2020). Post-Market Surveillance Approvals: Ensuring Pharmaceutical Product Safety. Drug Safety, 43(7), 621-636.

Vogel, M., Johnson, A., & Smith, E. (2019). Comparative Analysis of FDA and EMA Regulatory Frameworks: Implications for Global Market Authorization. Regulatory Science Journal, 36(3), 159-174.

Pauwels, K., Peters, N., & Thomas, R. (2017). Evolving Regulatory Frameworks in the Pharmaceutical Industry: A Dynamic Analysis. Drug Development Research, 78(5), 242-256.

Kumar, S., & Hilal, H. (2018). Enhancing Regulatory Reporting Through ERP Systems in Pharmaceuticals. International Journal of Information Technology and Management, 17(2), 136-152.

Li, J., Tan, R., & Wang, Q. (2019). Case Study: Overcoming Regulatory Challenges in Launching a Novel Biologic. Journal of Pharmaceutical Strategy and Management, 25(1), 45-61.

Wang, Y., Liu, X., & Zhang, Z. (2021). Challenges and Innovations in Customizing ERP Systems for Pharmaceutical Regulatory Compliance. Journal of Information Systems and Technology Management, 18, e3202.

Gupta, N., Patel, R., & Singh, A. (2020). ERP System User Survey in the Pharmaceutical Industry: A Comprehensive Analysis. Journal of Information Technology Research, 13(2), 67-84.

Jones, L., & Williams, M. (2015). The Role of ERP Systems in Pharmaceutical Quality Management. International Journal of Production Research, 53(7), 1955-1972.

Cruz, J., & Rodriguez, M. (2019). ERP Systems and Regulatory Compliance: A Case Study Approach. International Journal of Information Systems and Project Management, 7(2), 57-73.

Martinez, A., & Lopez, S. (2018). Integrating ERP and Regulatory Affairs: A Practical Guide for Pharmaceutical Companies. Journal of Enterprise Resource Planning Studies, 3(1), 12-28.

Johnson, C., & Brown, A. (2017). Regulatory Challenges and Solutions: Insights from the Pharmaceutical Industry. Regulatory Compliance Journal, 19(3), 145-162.

Smith, E., & Patel, A. (2019). Streamlining Pharmaceutical Compliance Through ERP Systems: A Case-Based Approach. Journal of Computer Science and Technology, 20(4), 411-428.

Lopez, R., & Hernandez, M. (2016). ERP Systems and Global Regulatory Harmonization in the Pharmaceutical Industry. International Journal of Business and Management, 11(7), 289-305.

Kaur, H., & Sharma, V. (2018). Role of ERP Systems in Navigating Regional Disparities in Pharmaceutical Licensing. Journal of Global Business Management, 12(2), 112-127.

Brown, P., & Williams, L. (2020). Challenges and Adaptations: A Study of Regulatory Compliance in the Pharmaceutical Industry. Journal of Applied Business Research, 36(5), 1355-1368.

Hernandez, J., & Rodriguez, A. (2017). The Impact of ERP System Integration on Regulatory Compliance: An Empirical Study. International Journal of Enterprise Information Systems, 13(2), 24-39.

Kumar, A., & Gupta, S. (2021). Innovations in ERP Systems for Pharmaceutical Regulatory Reporting. Journal of Information Technology Management, 32(1), 72-89.

Downloads

Published

2023-09-14

Issue

Section

Articles

How to Cite

AI-Driven Innovations in Healthcare: Improving Diagnostics and Patient Care. (2023). International Journal of Machine Learning and Artificial Intelligence, 4(4), 1-13. https://jmlai.in/index.php/ijmlai/article/view/24

Most read articles by the same author(s)

<< < 1 2 3 4 > >>