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Posted 10 May 2022 | By Mary Ellen Schneider 

Posters highlight research, regulatory updates at Euro Convergence 2022

3064 This year’s RAPS Euro Convergence features research and updates on the use of new technology and regulatory tools as part of the conference’s poster session.
 
Featured posters include an analysis of the regulatory challenges for products with artificial intelligence/machine learning, the best use of regulatory intelligence and automation, evolution in medical device labeling technology, implications of reforms to China’s National Medical Products Administration (NMPA), among others.
 
The conference is being held in Amsterdam from 10-12 May 2022.
 
Harnessing technology
 
A poster presented by Riddhi Masurkar of Northeastern University highlights the implementation, benefits and challenges of moving from paper to electronic instructions for use (IFU) in medical device labeling. The European Union has proposed transitioning to electronic IFU and other major global regulatory authorities, including the United States, Indian, Japan, Australia, and Saudi Arabia, are now accepting electronic IFUs.
 
The benefits include enhanced communication, supply chain optimization, easy accessibility by health care providers, cost efficiency, reducing paper waste, and the ability to make real-time updates. However, there challenges related to data validation, parallel access devices, usability in regions with low Internet connectivity, data security, risk management and version specific e-IFUs.
 
“Electronic IFUs have the potential to be a game changer in the healthcare industry,” Masurkar wrote. “It is a major step towards establishing sustainable manufacturing practices. Manufacturers with a drive for sustainability and an eye for efficiency, along with careful risk analysis can capitalize on this new technological approach.”
 
A poster from Cary Smithson of Phlexglobal explores the use of intelligent automation (IA) to enhance speed to market and regulatory compliance. For instance, the poster offers a use case for IA in production, including using the technology to simplify authoring and formatting, automating submission preparation and quality control, classifying documents in bulk, converting monolithic documents to structured content, and performing workflow automation. However, the poster also outlines the barriers, from a lack of understanding and buy-in to inadequate technology and insufficient quality data.
 
Overcoming regulatory challenges
 
AI/ML offer transformative potential in healthcare but their adoption lags that of other regulated industries, according to a poster by Daniel I. Chen, PhD, of Veeva Systems, Inc. The poster outlines the salient features shared by many novel regulatory frameworks for AI/ML but notes that both the US Food and Drug Administration and the European Medicines Agency have tabled novel regulatory frameworks aimed to promote AI/ML.
 
 
A poster from China Med Device, LLC, offers a look at changes in regulations and guidelines from the China NMPA and the implications for overseas manufacturers. Specifically, the poster outlines regulations and clinical guidelines supporting State Order 739, released in 2021. For example, for products not on the exemption list that need clinical evaluation, there are now two routes: clinical evaluation by substantial equivalence to a predicate device or a clinical trial.
 
Additional posters make the use case for post-market clinical follow-up surveys to proactively collect and evaluate clinical data from CE-marked medical devices, as well as for the use of regulatory intelligence analysis as part of regulatory strategy.

 

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