Open, transparent and collaborative

Mission

To provide an open, transparent and collaborative forum in a non-competitive environment in which Acedemia, Regulators, Industry and 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.

Goals

The Collaboration was formed between PhUSE, FDA and Industry 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 and project groups throughout the year by aligning working group 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.

CS Working Groups and Project Teams

PhUSE Collaborations are organized into a number of CS Working Groups, each with a broad topic area. Each CS Working Group has specific projects designed to achive a set of specific objectives.

CS Working Groups includ volunteers from major stakeholders including academia, the pharmaceutical industry, biologics industry, device industry, contract research organizations, core laboratory organizations, technology vendors, SDOs and interested regulatory agencies. Participation is open to anyone who wants to participate.

Each CS Working Group is led by a team designed to provide oversight for all projects within the Working Group ensuring that projects are aligned with overall goals of PhUSE Collaboration, that objectives are being met in a timely manner and that support is 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.

PhUSE CS Working Group Updates

The PhUSE CS Working Groups have been developing innovative solutions that address unmet computational science needs. A complete list of solutions can be found in the PhUSE CS Catalog of Deliverables. Join the PhUSE Collaboration for our ongoing series of webinars featuring updates from the PhUSE CS Working Groups as well as special guest speakers.

PhUSE US Computational Science Symposium 2017

The PhUSE Computational Science Symposium (CSS) will be celebrating its 6th annual event in 2017, having established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow, hosting its inaugural event in Europe during 2016 and engaging other regulatory agencies including the EMA and PMDA.

This year's event will once again be co-sponsored by the FDA and PhUSE and will bring together academia, regulators, industry and technology providers to address computational science needs in support of regulatory review.

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