ARGOS Global Conference: Parallel Session 1 – VPH

1. ARGOS Global Conference:Parallel Session 1 – VPH May 11th, 2011 Budapest

2. 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 innovationwithout 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

3. 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