Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

Regulatory NewsRegulatory News
| 10 May 2021 | By Kari Oakes 

The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.
Medical device strategies that span the Atlantic
On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health technologies that works for both the US and the EU market. Amiel’s presentation comes as part of an afternoon session entitled, “Turbulent Times in Europe: Why the US is taking over the lead in Medical Technology Innovation,” chaired by Jaap Laufer, Emergo’s medical director.
Amiel, senior director of digital efforts for VCLS, will review trends in marketing approvals for innovative software as a medical device (SaMD) solutions, calling out some of the key differences between the US and EU in SaMD regulation.
Highlighting the large bump in radiology SaMD devices that have received the CE mark since 2015, Amiel will also review trends in US FDA-approved or -cleared artificial intelligence and machine learning (AI/ML) devices that are being used in radiology, cardiology and other medical specialty areas.
Amiel’s presentation will emphasize the importance of data in achieving clinical-grade accuracy; data acquisition in support of the CE mark and FDA clearance or approval is a complex game where AI/ML devices are concerned. Amiel will chart a path to market on both sides of the Atlantic for these innovative devices, emphasizing critical challenges and effort that can be shared for submission to both regulators.
Building a modern regulatory strategy
Also on Tuesday, Sanofi’s Charlie Mortazavi will lead a session focused on how to optimize development strategies for innovative products. Saman Kay, a Clarivate regulatory intelligence consultant, will kick off the discussion by setting forth considerations for building a regulatory strategy that works in today’s modern device and therapeutics environment. Kay will highlight what makes a regulatory strategy different than a corporate strategy and review different analytical methodologies.
Next, Winona Rei Bolislis of Sanofi’s global regulatory science and policy division will review how real-world data (RWD) can be used for regulatory decision-making. Bolislis’ presentation will detail exactly which drug and device approvals and extensions have relied, in part, on RWD.
In fine-tuning her examination of how RWD have been used, Bolislis will also dive into just how the data have been used in support of regulatory submissions, and which sources sponsors have drawn from in building real-world datasets.
In the final talk of this session, Thomas Kuhler, the head of global regulatory science and policy for Sanofi’s EU, Africa, Middle East and Eastern Europe efforts, will focus on pragmatic approaches to optimize pediatric medicine development in the EU.
Kuhler plans to discuss some realistic “asks” of European regulators that address nuts and bolts of compliance with pediatric investigation plans (PIPs) to ameliorate pain points pediatric investigators may encounter.
A new take on the IVDR conundrum
Another Tuesday session addresses the fast-approaching IVDR deadline of 26 May 2022. Lisa Casavant of RQM+ will lead panelists through a discussion that shares IVDR strategies and solutions that have worked thus far. Panelists will share real-life instances of both successes and failures; the notified body perspective will be presented by Andreas Stange, vice president of TÜV SÜD Japan.
Amie Smirthwaite of RQM+, Abbott’s Simon Richards and Laura Tracy of Leica Biosystems will round out the panel. Planned topics include how to develop a robust quality management system, addressing risk management in the IVD space, looking at post-market surveillance details and how to set up economic operator agreements.
Finally, panelists plan to help attendees decide how to know when preparations are “good enough” in the context of a new and evolving regulatory landscape.
RAPS Euro Convergence 2021


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