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 and evaluation of current tools by users themselves.
The FDA and PhUSE have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions 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.
When: March 19-21, 2017
Location: Silver Spring Civic Center, 1 Veterans Place, Silver Spring, MD 20910
Goals and Objectives
The goals of the program are to facilitate the ongoing efforts of the PhUSE working groups to:
- highlight 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, software tool design who work in 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
It is anticipated that a total of 300 people, from FDA or other federal agencies, the pharmaceutical industry, and academia, will be participating in the program.
Contact: Shaniece Bowens at Shaniece.email@example.com