FDA/PHUSE Computational Science Symposium September 19 - 21, 2022

Symposium | In Person

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• Date: September 19 - 21, 2022
• Day1: Mon, Sep 19
• Day2: Tue, Sep 20
• Day3: Wed, Sep 21

The meeting will be held September 19 – 21 in Silver Spring, Maryland and as a hybrid-virtual event.

Event hours:

• Monday 9/19: 3pm -5pm.
  • Welcome event 5 - 6pm, Safety Analytics Workshop 6 - 7pm
• Tuesday 9/20: 9am - 5pm.
  • Posters 5 – 6:30pm
• Wednesday 9/21 9am - 4pm

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 Limited

Kent Innovation Centre

BROADSTAIRS

Kent

CT10 2QQ

England, UK

Tel: +44 1843 609601

If to FDA:

Catherine Li

Catherine.li@fda.hhs.gov

FDA/CDER/OTS/OCS

Building 21, Office 1520

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 21029