BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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Page 24 of 33 October 2021 eBook BioPharm International 25 to comply. In the meantime, compa- nies are encouraged to be proactive in establishing a data-handling frame- work and setting up policies that will help them align with the forthcoming regulations. A robust framework and processes put into practice by compa- nies in regulated environments could serve as the basis for new regulations for AI, making it easier for these com- panies to comply. I m p l e m e n t i n g s o l u t i o n s a n d processes for ensu r ing data qua l- it y is necessar y for sca labilit y and ongoing relevance in the industr y. Organizations that embrace digitiza- tion for the creation and curation of data to pursue trends in AI will effec- tively circumvent the challenges and risks inherent with the technolog y. Modernizing data handling enables companies to identif y and mitigate issues that could other wise lead to inaccurate AI outcomes. REFERENCES 1. Sumitomo Dainippon, "Sumitomo Dannippon Pharma and Exscientia Joint Development New Drug Candidate Created Using Artificial Intelligence (AI) Begins Clinical Study," ene20200130.pdf, Jan. 30, 2020. 2. G. Press, "A Very Short History of Artificial Intelligence (AI)," forbes. com, Dec. 30, 2016. 3. A. Kudumala, D. Ressler, & W. Miranda. "Scaling Up AI Across the Life Sciences Value Chain," deloitte. com, Nov. 4, 2020. 4. A. Powell, "AI Revolution in Medicine,", Nov. 11, 2020. 5. FDA, "Resiliency Roadmap for FDA Oversight," download, May 2021. 6. FDA, "Data Modernization Action Plan," modernization-action-plan, Mar. 3, 2021. 7. FDA, "Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS)," media/145001/download, 2021. 8. FDA, "Real World Evidence," fda. gov/science-research/science-and- research-special-topics/real-world- evidence, July 16, 2021. 9. K. Zo et al., J Multidiscip Healthc, 2020; 13: 671–679. July 22, 2020. 10. UN News, "WHO Guidance on Artificial Intelligence to Improve Healthcare, Mitigate Risks Worldwide," story/2021/06/1094902, June 28, 2021. 11. M. McCarthy, "Artificial Intelligence in Health: Ethical Considerations for Research and Practice," resources/artificial-intelligence-health- ethical-considerations-research-and- practice, June 17, 2019.BP Regulatory Sourcebook Data Integrity CALL FOR PAPERS BioPharm International accepts four types of peer-review papers that are considered: standard data-driven, novel research; topical literature or patent review; technical case studies/technical application notes; and science-based opinion papers. Manuscripts for peer-review papers are accepted on an ongoing basis. Publication priority is given to papers in the order they are accepted for publication. Submitted papers are initially screened by the editors, then submitted for formal review by a member of the editorial advisory board, who will review the article for technical interest and content in a double-blind review process. Article acceptance is conditioned on the reviewer's approval. Once accepted for publication, a paper typically is published within three to five months. Peer-review papers are published in the print and digital editions of BioPharm International, and on Links to the online versions of peer-review papers also are featured in e-newsletters distributed to the publication's audience. To learn more about the peer-review submission process, click the Submission Guidelines link on C A L L FOR PAP ERS C A L L F O R P A P E R S CALL FOR PAPERS

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