ARGOS Global Conference:Parallel Session 1 – VPH

May 11th, 2011Budapest

VPH Breakout Summary There was support for the current draft; we discussed

topics to add rather than subtract We recognized the importance of the research and clinical

communities as stakeholders, and recommended increasing the prominence of the importance of the proposed infrastructure to the biomedical device and pharmaceutical industries

Strengthen the ability of the proposed infrastructure to serve as an incubator for innovation without prescribing a specific business model (while citing possible examples)

Some continued discussion of terminology Expanded discussion of role of regulatory agencies, such

as FDA, EMA and non-medical agencies such as EPA, EEA, NIST

Industry/Regulatory Agency Perspectives

Industry is interested in taking advantage of models to give them a competitive advantage, but are more reluctant to share them especially if a consequence is that it makes their numerical investigations reproducible

Regulatory agencies are very interested in taking advantage of standardized models to improve regulatory filings especially if a consequence is that it makes results in applications reproducible, but agencies are concerned about compromising industry competitiveness with additional regulatory mandates