Future directions in regulatory affairs

Chisholm, Orin; Critchley, Helen

doi:10.3389/fmed.2022.1082384

Cited by 9 publications

(8 citation statements)

References 69 publications

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“…Along with the technologies that appear in the AI term, there have also been marked change and development driven by technological advancements. Furthermore, the increase in data availability and computing power has further accelerated the development of AI in different applications, ranging from autonomous driving to medicine (Chisholm and Critchley 2023) or manufacturing processes with fully autonomous plants (Gamer et al 2020).…”

Section: Strategicmentioning

confidence: 99%

“…Authors Title (Bag et al 2023) Big data analytics and artificial intelligence technologies based collaborative platform empowering absorptive capacity in health care supply chain: An empirical study (Chisholm and Critchley 2023) Future directions in regulatory affairs (Gallo, Khadem, and Alzubi 2023) The Relationship between Big Data Analytic-Artificial Intelligence and Environmental Performance: A Moderated Mediated Model of Green Supply Chain Collaboration (GSCC) and Top Management Commitment (TMC) (Gong 2023) Digital transformation of supply chain management in retail and e-commerce (Gupta et al 2023) Profitability and pricing decision-making structures in presence of uncertain demand and green technology investment for a three-tier supply chain (Osama, Elgarhy, and Elseddawy 2023)…”

Section: Findings Andmentioning

confidence: 99%

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Artificial Intelligence Use in Collaborative Network Processes

Andres,

Fernandez-Garcia,

Urze

et al. 2024

Preprint

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The paper seeks to outline the impact of artificial intelligence (AI) on collaborative networks (CNs) by thoroughly examining the current literature. Given the growth of AI and its limited exploration in many business strategies, especially when collaboration among networked partners is established, this paper focuses on defining the research lines and AI application in CN processes by advancing some relevant ideas about how AI can improve networks’ resilience and antifragility. It discusses research on the integration of AI in CN from the following perspectives: (i) the collaborative processes addressed, (ii) the level of decision-making, (iii) the partners involved in the collaboration; (iv) the technologies that are jointly used with AI to support CN processes; (v) the programming languages implemented to develop AI algorithms; (vi) the sectors in which it AI is mainly implemented, and (vi) the potentialities of IA in CN in an increasingly turbulent and disruptive business world. The literature review has provided a global comprehension of the interplay between CN processes and AI-driven advancements, providing a response about the technologies that can merge with AI to support CN processes. The results derived from the literature analysis have allowed the establishment of a conceptual framework for AI use in CNs and outline future research directions in this field of study.

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Section: Strategicmentioning

confidence: 99%

Section: Findings Andmentioning

confidence: 99%

Artificial Intelligence Use in Collaborative Network Processes

Andres,

Fernandez-Garcia,

Urze

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…They must stay abreast of changes and communicate them to internal stakeholders. This requires watching regulatory organizations, attending conferences and workshops, and networking with other experts to obtain regulatory intelligence [53].…”

Section: Skills Needed For the Future Regulatory Affairsmentioning

confidence: 99%

“…10) Continuous learning and development: The regulatory landscape is constantly evolving and adapting to changes in technologies, market dynamics, and consumer demands. Therefore, a future regulatory affairs professional must have a growth mindset and a commitment to continuous learning and development [53]. This involves seeking out new opportunities for professional growth, staying updated on industry developments, and continuously developing new skills to stay relevant in the field.…”

Section: Skills Needed For the Future Regulatory Affairsmentioning

confidence: 99%

Introduction to Regulatory Affairs and Different Regulatory Bodies for Pharmaceutical Products and Impact of Digitalization on Regulatory Affairs

Huma,

Peng

2023

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To ensure the quality and marketability of products, the field of regulatory affairs (RA) serves as an intermediary between regulatory bodies, the industry, and consumers. The primary objective of pharmaceutical registration is centered on the marketing process. The World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), and World Intellectual Property Organization (WIPO) play crucial roles in the process. Drug registration and commercialization are overseen by national regulatory authorities initially, following the guidelines of the key organizations. The phenomenon of digital disruption is widespread and has significant effects on several domains of work. This influence has been further intensified by the COVID-19 epidemic, as well as the rapid advancements in the complexity and capabilities of machine learning and artificial intelligence algorithms. The future of this profession is influenced by various trends, including the swift progress in scientific comprehension of diseases, which has resulted in the emergence of novel therapeutic approaches for the treatment and potential eradication of some ailments. The importance of strategic collaborations, alignment, and integration among national regulatory agencies has been heightened by recent global regulatory reforms. This trend is expected to persist. The impact of these elements on regulatory professionals, medication development, and medical practice in the future is a subject of considerable attention. The enhancement of skills and the adoption of a growth mindset are crucial for regulatory affairs professionals to implement the necessary adjustments. This emerging paradigm promotes the cultivation of personal responsibility in individuals' professional development, fostering adaptability and emphasizing the significance of lifelong learning. Through their actions, these specialists could exert influence on the process How to cite this paper: Huma, T. and Peng, Z.

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“…The study design may include randomisation and blinding techniques to ensure the validity of the observations. 14 Phase 1 clinical trials may include the following studies: An evaluation of the drug's initial safety and tolerance, encompassing both single-dose and multiple-dose delivery.…”

Section: Phase I -Human Pharmacology Studiesmentioning

confidence: 99%

An Overview on Development, Approval and Post Registration Activities for Pharmaceuticals in European Union

Thanush D,

Balamuralidhara V,

Thoyajaksha V

et al. 2023

Ind. J. Pharm. Edu. Res

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Bringing a new medicine from concept to market is costly and complex. Years of study and development go into it. Product development operations should be carried out in line with applicable regulatory standards to save time and money when bringing innovations to the marketplace. While the information on regulatory requirements is readily accessible, navigating the regulatory system is complex and becomes considerably more difficult when working with many countries. The primary goal is to improve regulatory awareness and achieve regulatory compliance in product development. An excellent place to start is with one of these ideas. The guide is not a list of laws but a discussion of the foundational ideas and principles governing regulatory policymaking and enforcement in the European Union. Throughout the drug's lifespan, these rules are consistent. Companies may standardise their processes and keep track of every action at every step of the lifecycle by developing a workflow and adhering to its stages of lifecycle compliance for each set of guidelines. Because of the current pharmaceutical market's complexity, more efficient drug research and manufacturing are required. This review article is based on the information collected from various sources from EMA and ICH websites and the articles mentioned. Despite the extreme complexity, Product Lifecycle Management has the potential to make pharmaceutical manufacturing more efficient and less risky. Pharmaceutical product lifecycle management during various phases such as research and development, regulatory submission and approval, commercialisation and marketing plays a significant role.

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Future directions in regulatory affairs

Cited by 9 publications

References 69 publications

Artificial Intelligence Use in Collaborative Network Processes

Artificial Intelligence Use in Collaborative Network Processes

Introduction to Regulatory Affairs and Different Regulatory Bodies for Pharmaceutical Products and Impact of Digitalization on Regulatory Affairs

An Overview on Development, Approval and Post Registration Activities for Pharmaceuticals in European Union

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