Open, Transparent and Collaborative
To provide an open, transparent and collaborative forum in a non-competitive environment in which academia, regulators, industry, technology providers and others can address computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them.
The collaboration was initially formed between PHUSE, the FDA and industry and has been extended across other regulatory agencies and stakeholders with the following goals:
- To facilitate discussions among regulatory agencies, industry and other stakeholders that inform and improve computational science, to support product development and review.
- To bring together experts in specific areas to collaborate on computational science, describe best practices in challenging areas, and propose methods for addressing knowledge gaps.
- To support ongoing collaborative Working Groups and Projects throughout the year by aligning Working Groups objectives, reviewing project requests, and deliverables, and providing direction for project issues and gaps.
- To establish an infrastructure and operational processes to support the collaboration.
Working Groups and Project Teams
PHUSE collaborations are organised into a number of Working Groups, each with a broad topic area. Each Working Group has specific projects designed to achieve a set of specific objectives.
Working Groups include volunteers from major stakeholders including academia, the pharmaceutical industry, biologics industry, device industry, contract research organisations, core laboratory organisations, technology vendors, SDOs and interested regulatory agencies. Participation is open to anyone who wants to contribute.
Each Working Group is led by a team designed to provide oversight for all projects within the Working Group, ensuring projects are aligned with the overall goals of the PHUSE collaboration and that objectives are being met in a timely manner and that support is being provided for project leaders.
Each project has one or more leaders responsible for leading the project, scheduling meetings, working with the project team to meet objectives and providing updates to the Working Group leadership team.