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Articles by Renato Rjavec
The now-urgent automation agenda: out-of-control regulatory workloads necessitate AI adoption
That regulatory workloads are soaring across the international life sciences industry is well acknowledged. A new survey, conducted for ArisGlobal by Censuswide with senior regulatory professionals in US pharma and biopharma organizations, confirms not only that almost all have seen their regulatory obligations expand over the last five years, three in five (60%) put the increase beyond what would be expected as the result of company growth. A trend that is not showing any signs of waning.
Could GenAI auto-generate entire regulatory dossiers?
Generative AI (GenAI) technology is already transforming everyday regulatory and safety processes, thanks to its ability to digest, assess, and summarise key insights and findings from across vast and diverse bodies of existing content, and data - even as this is being continuously refreshed. Pilot solutions are now available to help companies pre-empt Agency queries and build stronger marketing authorisation applications, with greater efficiency.
Employing Generative AI to Transform Regulatory Intelligence Insights and Processes
There is a real opportunity for Artificial Intelligence to maximise Life Sciences companies’ investment in regulatory data management. ArisGlobal’s Agnes Cwienczek & Renato Rjavec set out practical examples of artificial intelligence (AI) and Generative AI delivering tangible benefits.
Preparing for a Data-first Regulatory World
Even in today’s eCTD world, most life sciences regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorization and variations submissions. Yet it is data, rather than pre-prepared dossiers, that are moving into central focus now.
Data-Based Regulatory Submissions: What DADI Means for You
The European Medicines Agency (EMA) has announced that the European Commission’s Up-Scaling the Global Univocal Identification of Medicines (UNICOM) initiative’s Digital Application Dataset Integration (DADI) project will be leveraged to implement regulatory data submissions. Amplexor’s Renato Rjavec looks at what this means for the pharma industry. Pharma has long needed a more data-driven and standards-based method of managing regulated product data.
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