EMA's white paper: guidelines for the inclusion of digital evidence in regulatory filings in the pharma domain

The recent publication of the white paper developed by members of VPHi, EMA, national regulators and industry is a first step in the direction of clear guidelines for the inclusion of digital evidence in regulatory filings in the pharma domain.

In silico technologies are penetrating healthcare at breakneck speed. Drug design and development has a long-standing tradition in the use of in silico technologies. Yet the in silico toolbox is rapidly expanding beyond the classical QSAR, PK/PD and PBPK. When these tools are used in the design and development of drugs, they might eventually end up in a regulatory application. In order for the regulatory bodies to accurately and expertly handle this digitally created evidence, this digital evidence needs to follow certain reporting standards, demonstrating appropriate verification and validation (V&V) of the results (cfr ASME V&V40).

On April 25-26 2019, Belgian regulators, Belgian VPHi researchers and Avicenna Alliance industrial partners met in Leuven to start the process of defining a set of practical guidelines to tackle the validation challenge of in silico models for drug development. The two days were filled with presentations from the different stakeholders, brainstorms and discussions. The results of this initial meeting will be published as a perspective paper: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.12504

In the 2 years that followed this meeting, a working group consisting of members of the European Medicines Agency (EMA), national regulator, VPHi members and industry partners from the whole of Europe met regularly to discuss how to provide the community with clear guidelines for demonstrating credibility of their digital evidence in the pharma domain. This working group will produce a comprehensive white paper that can be found here: https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12669 . One particular element that often came up during the meetings is the lack of understanding of terminology and how the terms are (differently) interpreted by the different participants of the working group. This is why the white paper starts with a discussion on some of the most commonly used terms in the paper.

Future activities of the VPHi-Avicenna task force on EMA collaboration include the organization of triple helix expertise exchange meetings where topics can be addressed that are not clearly dealt with in the white paper. For instance, the first workshop dealt with drug-device interaction modeling (see https://www.youtube.com/watch?v=sMdarJV_72w for a video of the event). In the future, other topics will be discussed in that platform when a need is identified by any of the partners.



Date: 06/10/2021 | Tag: | News: 1227 of 1231
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