FDA-PhUSE Computational Science Symposium

Date

March 4-6, 2018

Time

Location

Silver Spring Civic Center 1 Veterans PL Silver Spring, MD 20910

I. BACKGROUND

Nature and Purpose of the Event:
 

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.

The FDA and PhUSE have expressed a willingness to leverage their combined strengths for the joint development of this annual symposium.  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 share practices that will ensure effective and efficient regulatory review of data submissions 
• 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 on organization performance
• 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 pharmacologists, and other drug development and review scientists
• 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.  

Contacts

Shaniece Bowens:shaniece.bowens@fda.hhs.gov