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Event Title
FDA/PHUSE Computational Science Symposium (CSS)
September 18 - 20, 2023

September 18 - 20, 2023
- ET
- ET
- ET


At the FDA/PHUSE Computational Science Symposium, participants will review progress on topics such as data standards, best-practices-driven analytical tool development, business processes that are driving development of information systems, as well as both the experiences with and evaluation of current tools by users.

This annual meeting brings together FDA, industry, and academia to work together in a non-competitive environment to find solutions to shared problems and challenges.

Goals and Objectives

The goals of the program are to facilitate the ongoing efforts of the PHUSE Working Groups to:

  • discuss both the need for a modern bioinformatics platform to support regulatory review and communication and the challenges of developing it
  • share progress on data standards implementation between regulators and regulated industries
  • discuss and develop the needs and specifications for proposed new tools and solutions 
  • describe best practices (process, tools) implementation experiences, and the subsequent impact of computational technologies
  • discuss and find solutions to common needs of regulators, industry, and academia in the drug development and review lifecycle

Who Should Attend

The target audience for this program includes:

  • Physicians, biostatisticians, epidemiologists, clinical and nonclinical pharmacologists, and other drug development and review scientists (e.g., data scientist, computer scientist)
  • Professionals in data management, programming, information management, and software tool design who work in the fields of drug and biological product research, development, and regulation
    • Pharmaceutical industry (preclinical, pre-market, post-market development, IT)
    • Contract research organizations
    • Government organizations (FDA, NIH, EMEA, PMDA, KIKO)
    • Information management and bioinformatics companies
    • Standards Development Organizations (SDO)
    • Tool Vendors
    • Academia

It is anticipated that a total of 300 people, from FDA and other Federal agencies, the pharmaceutical industry, and academia, will participate in the symposium. 


If to PHUSE:

PHUSE Limited
Kent Innovation Centre
Kent, England, UK
Tel: +44 1843 609601

If to FDA:      

Catherine Li
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Translational Sciences
10903 New Hampshire Avenue
Silver Spring, MD 21029

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