The Alliance aims to work on:
- Temporary framework to synergize and tackle larger scale projects
- Harmonizing & standardizing a reference set to be used in end to end workflow by:
- Creating tools and datasets
- Progressing and enabling market access
- Creating clarity on regulatory pathways via mock submissions
- Harmonizing efforts between various stakeholders to optimize interoperability, integration and implementation
Following is a brief explanation of the differences between the DPA and the Alliance:
- DPA R&S TF works on standards as well as regulatory, see https://digitalpathologyassociation.org/digital-pathology-association-regulatory-committee
- DPA defining clear regulatory deliverables and general principals such as Clinical Validation guidelines, regulatory pathways – more the outputs towards getting innovation on market
- DPA to become the “home” for the Alliance – whatever Alliance delivers (phantom, guidance, etc.), DPA will be main driver, host, etc.
- The Alliance works on regulatory science – driving more towards how to get to the next step
- Alliance is temp and no membership fee
- The Alliance for Digital Pathology – https://digitalpathologyalliance.org/
- A regulatory science initiative to harmonize and standardize digital pathology evaluation processes to speed up innovation to patients.
- The Alliance for Digital Pathology is a collaborative and voluntary group interested in the evolution of regulatory science as it applies to digital pathology. We seek participation from all stakeholders (industry, vendors, academic medical centers, patient advocates, regulatory bodies, associations, etc.) to come together and identify key elements necessary to move the field of digital pathology forward.
- The purpose of the Alliance is to accomplish concrete practical deliverables and relevant strategic aims that can inform regulatory decision making.
For information on past meetings and more, please click here.
MDIC seeks participation in new digital pathology collaborative effort
MDIC, FDA and the Digital Pathology Association are planning to meet to prioritize the areas of digital pathology for which MDIC can bring together stakeholders in the areas of industry, users, government, insurance companies and patients to collaboratively work on developing new resources in the areas of digital pathology. The first steps have been made to establish a temporary alliance between the participating entities. The alliance will grow to incorporate additional stakeholders and MDIC encourages your participation as we develop project aims and deliverables.