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Articles by Agnes Cwienczek
Reg impact assessment next in GenAI’s sights, experts claim
AI-powered process automation is ideally suited to this vital front-end aspect of product change control, say Preeya Beczek and ArisGlobal’s Agnes Cwienczek. As confidence builds in Regulatory AI use with practical experience of the technology’s potential, domain leaders are seeing regulatory impact assessment (as part of product change control) as the next obvious candidate for transformation.
GenAI: Automating Regulatory Submissions
With its ability to digest, assess, create and summarize key insights from diverse bodies of existing content, and data – even as this is continuously refreshed – generative AI (genAI) has the potential to transform everyday regulatory and pharmacovigilance processes in the pharma industry.
Are Pharma Regulations Hindering AI-Driven Transformation?
A recent survey of 100 United States senior regulatory personnel in pharma/biopharma suggests that the industry may be inhibiting its own progress with smarter resource management and transformed process efficiency because of outdated attitudes to artificial intelligence (AI) and machine learning.
AI UPDATE - Could Generative AI Take Over Regulatory Submissions?
Early pharma pilots of generative AI (GenAI) technology in a Regulatory Affairs context have highlighted its existing potential as a process accelerator. Across 23 different languages, up to 12 fields of data have been extracted with 90% accuracy. This was done with 80% faster processing and three times fewer handovers than without GenAI use.
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.
Beyond IDMP - Act Now to Reap the Benefits of eCTD 4.0 Compliance
Agnes Cwienczek, ALSS Head of Product Management and Consulting, ArisGlobal, discusses the benefits of acting now to reap the benefits of eCTD 4.0 compliance. By as soon as 2026, regulatory bodies around the world will start to require compliance with the more recently finalised and published eCTD 4.0 dossier submissions standard(s). Compliance is largely voluntary across international markets, but between 2026 and 2029, new requirements will start to be enforced.
Is robotic process automation a panacea to transform regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
The Benefits of Structured Content Management in Life Sciences
There are all sorts of valid and practical reasons for life sciences organizations to be collecting, preparing, publishing/submitting and managing increased data in 2020, and — now more than ever — to be doing this in a structured way, using structured data. Regulatory agencies are demanding increased safety and traceability detail, requirements about what goes on packaging and labeling are becoming more stringent, and the public is calling for greater transparency about the products they use.
Lifting the lid on robotic process automation
Today, robotic process automation (RPA) registers strongly on the radar of Regulatory Affairs departments; many companies are talking about it or looking at it, if not actually already using it. But is it being used to its full potential? Amplexor’s Agnes Cwienczek separates the fact from the fiction and offers a pragmatic plan for life sciences firms to derive measurable benefits.
Robotic Process Automation: Adding Intelligence to Optimize Regulatory Processes
Regulatory affairs and regulatory operations departments handle huge volumes of admin. Robotic process automation (RPA) is increasingly helping with the more routine tasks, saving time and reducing human error while freeing up people to apply their expertise and add value. Now that life sciences organizations have seen for themselves the tangible benefits of RPA, they are beginning to think about where they could take the technology next.
Electronic product information: Preparing to go digital-first
Electronic product information promises to be a much more efficient and patient-friendly way of disseminating up-to-date manufacturing details and safety advice to patients and health professionals. But how prepared is the European pharmaceutical industry to deliver regulated product information in this way? Amplexor’s Agnes Cwienczek considers how companies might best prepare for delivering reliable electronic product information.
MedTech Intelligence Volume 12 Issue 23
Volume 12 Issue No. 23 Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory Soapbox Electronic Product Information: A Roadmap to the Business Benefits By Agnes Cwienczek, AMPLEXOR Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators.
Electronic Product Information: A Roadmap to the Business Benefits
Health and regulatory agencies across the world are showing increasing interest in introducing standardized requirements for electronic product information (ePI). At the same time, patients and healthcare professionals are increasingly receptive to digital delivery of ePI.
How to move ahead with labelling management
However much improved life sciences firms are in their approach to regulatory information management, labelling continues to buck the trend. Siloed systems and an over-reliance on manual checks continue to incur risk, delay and cost, especially across international operations. In this article, Amplexor senior life sciences consultant Agnes Cwienczek advises on an alternative way forward.
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