Steering Committee Charter
- 1 Purpose
- 2 PhUSE Computational Science Collaboration
- 3 Steering Committee
- 4 Representation from the FDA
The purpose of this document is to define the operating guidelines for the Pharmaceutical Users Software Exchange (PhUSE) Computational Science Steering Committee which oversees the work of the PhUSE Computational Science collaborations. These collaborations include the Annual PhUSE Computational Science Symposium and the ongoing work of project teams within the PhUSE Working Groups.
PhUSE Computational Science Collaboration
PhUSE is an Independent, Not‐for‐profit organization run by volunteers. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.
To provide an open, transparent, and collaborative forum in a non‐competitive environment in which Academia, 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.
The Collaboration was formed between the non‐profit organization, 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 support an annual public conference where collaborators and interested individuals come to together to summarize and share work accomplished to date and plan for future efforts
- To establish an infrastructure and operational processes with the following components:
- Transparent processes that promote exchange of ideas
- Help gather input from all primary stakeholders (e.g. FDA, industry, academics, standard development organizations (SDOs))
- Create an open and efficient method for submitting potential projects and providing an objective evaluation and approval process for proposed projects
- Provide a framework for handoff of deliverables between project teams and appropriate organizations using formal processes as defined by the receiving organizations
Working Groups and Project Teams
- PhUSE Collaborations are organized into a number of Working Groups with each Working Group having a broad topic area. Each Working Group will have specific projects designed to achieve a set of specific objectives.
- Working Groups include volunteers from major stakeholders including, but not limited to, 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 Working Group is led by a team designed to provide oversight for all projects within that 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.
Annual PhUSE Computational Science Symposium
The Annual Computational Science Symposium brings together Academia, Regulators, Industry and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them. The focus of the Annual Computational Science Symposium is to continue the work initiated at the previous annual meetings by bringing FDA, industry and academia together to provide an update on current initiatives ongoing within the FDA, explore emerging technologies and establish collaborative working groups to address current challenges related to the access and review of data to support product development.
The Steering Committee will include the following:
- Consist of at least 1 voting member from each Working Group and a group of at large voting members including representation from Academia, Industry and Technology Providers.
- FDA will sustain at least 3‐5 non‐voting Advisors to the Steering Committee, including at least one from each of CDER, CBER, and CDER CSC
- May increase the number of appointed members, change its size or composition, or remove a member with the approval of a two‐‐‐thirds majority of the Steering Committee.
- Members will be appointed to serve a two year term. Members may invite external advisors to attend meetings where appropriate to assist in decision‐‐‐making.
- A voting quorum consists of a simple majority of sitting members and voting procedures may be by electronic media.
- The Chair is elected by majority vote of sitting members for a term of two years; the Chair may not serve more than two consecutive terms. An interim chair may be selected by unanimous vote prior to an election.
- The Steering Committee is responsible for approving each project . A project must be defined in a project request form (sent to the Steering Committee) before it can be approved.
- Changes to Steering Committee Charter can be made by two‐thirds affirmative vote of the voting membership present at any meeting. Proposed changes must be sent to the Steering Committee 30 days before the scheduled meeting.
- A Working Group or project can be discontinued with the two‐thirds approval of the Steering Committee
Guiding Principles of Steering Committee
The Steering Committee intends to follow a set of guiding principles in overseeing the work of Working Groups and Project Teams which will include the following:
- Minimize bureaucracy: “Use as little governance as possible but no less”
- Minimize intervention: Push decisions down to the lowest responsible levels
- Leverage existing work where possible and clearly define boundaries and links to other existing standards; develop only when needed
- Define a manageable scope to fit a pre‐determined timeframe.
- Strive to adjust scope and ensure sufficient resources before extending time schedule for each project
- Ensure that project and Working Group objectives are relevant to all participating parties
- Consistently define all concepts. Reuse, don't recreate.
- Ensure that all projects are defined to deliver value to all participating collaborators
Steering Committee Guidelines for Prioritizing Projects
The Steering Committee will define a set of guidelines used to prioritize projects, which will include the following:
- Well defined, manageable scope, capable of being accomplished within a pre‐determined timeframe
- Goals of the project are attainable within the context of the Collaboration
- Projects will not provide a deliverable that will involve regulatory agency policy or give the perception of impacting regulatory policy
- Each Project will have at least two co‐leads and sufficient participating members to ensure success
Representation from the FDA
The participation of the FDA will be guided by the Memorandum of Understanding executed between FDA and PhUSE (August, 2013). The FDA will appoint advisors to the Steering Committee and, as needed, to the other Working Groups and projects within those groups. Such Advisors will not have any fiduciary roles in the Collaboration and will be non‐voting.