Computational Science Symposium
Silver Spring, Maryland
June, 9th–11th 2019
Having established itself as the premier collaboration across industry, regulators, and service/technology providers, the Computational Science Symposium (CSS) will be celebrating its eighth annual event. The collaboration has continued to grow, with nearly 60 active projects across 6 Working Groups, regulatory engagement from the FDA, EMA, and PMDA and publication/reference of PhUSE deliverables in journals, online, and regulatory guidance.
This year's event will be moved from the traditional March timeframe to June, to make room for our second annual US PhUSE Connect in February 2019. The annual CSS brings together a broad range of stakeholders 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 meeting and throughout the year. The event will provide an update on current initiatives ongoing within the FDA, explore emerging technologies, and establish collaborative projects to address current challenges related to the access and review of data to support product development.
Since the US CSS 2018, the projects within the Working Groups have been meeting, collaborating and delivering valuable outputs as part of their objectives. Click here to read further information on all Working Groups and their projects, with links to information about each one.
Over the past year, the Working Groups projects have successfully delivered on their objectives to support the overall mission of the collaboration. Below are samples of those successful projects and the great work being done by many volunteers.
Leveraging Blockchain in Pharmaceutical and Healthcare Industries: A forward-thinking White Paper which makes the case that blockchain is a disruptive technology for pharmaceutical and healthcare industries, and the need for a cultural movement that our industries should embrace.
Study Data Reviewer’s Guide in XML: First draft of representing the SDRG in XML so it can be machine-readable and used to automate processes within industry and regulatory groups.
Study Data Standardization Plan (SDSP): The CDER and CBER Study Data Standardization Plan (SDSP), created by the PhUSE Working Group Optimizing the Use of Data Standards, is referenced in the FDA Study Data Technical Conformance Guide (TCG) released in March 2018. It establishes a plan for describing the data standardisation approach for clinical and nonclinical studies within a development program. The SDSP assists the FDA in identifying potential data standardisation issues, early in the development programme.
In addition to the regularly scheduled activities, including an opening session by the FDA, Working Groups collaborations, Poster Sessions, networking, and other exciting activities are being planned.
The Working Groups Steering Committee are accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development, and must meet all the guidelines for projects within the FDA/PhUSE collaboration.
Click here for more information and to download the New Project Request form. New projects can be submitted at any time, but the deadline has now passed for inclusion in the 2019 conference.
The conference will commence at 4pm on Sunday, June 9th, with the opening networking session, and end at 4pm on Tuesday, June 11th.
Online registration is now open. The Symposium is limited to 300 attendees, so do ensure you register early, before the event sells out.