Date: Day1: Mon, Sep 13 10:00 AM - 5:00 PM ET Day2: Tue, Sep 14 9:00 AM - 4:00 PM ET Day3: Wed, Sep 15 10:00 AM - 5:00 PM ET

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. 

Contact
If to PHUSE:
PHUSE Office
Kent Innovation Centre
BROADSTAIRS
Kent, CT10 2QQ
England, UK
Tel: +44 1843 600600
Fax: +44 1843 265850
[email protected]

If to FDA:
Catherine Li
FDA/CDER/OTS/OCS
White Oak Building 21, Office 1609
Food and Drug Administration
10903 New Hampshire Avenue                                              
Silver Spring, MD 21029
[email protected]