FDA/PHUSE Computational Science Symposium September 13 - 15, 2021

Meeting | Virtual

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• Date: September 13 - 15, 2021
• Day1: Mon, Sep 13
• Day2: Tue, Sep 14
• Day3: Wed, Sep 15

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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
office@phuse.global

 

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
catherine.li@fda.hhs.gov