User:Dirkspruck/sandbox

The PhUSE is the main global professional organization for Clinical Data Scientists and related professionals. The inaugural meeting of PhUSE ("Pharmaceutical User Software Exchange") was on 16th September 2004 in London and the Society was founded in 2008. PhUSE is the biggest biometrical professional society in the world. PhUSE services Clinical Data Scientists, statistical programmers, biostatisticians, and other professionals working with clinical research data. Main topics discussed in the PhUSE community include the programming with statistical software packages like SAS and R, the implementation of Clinical Data Interchange Standards Consortium’s (CDISC) data standards and the submission of clinical research data to regulatory authorities.

Mission
"Providing the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer supported, community of professionals who are passionate about advancement of clinical data science."

Membership
At the end of 2013 PhUSE had more than 2800 members, found in the pharmaceutical industry, government, and academia.

At the end of 2013 PhUSE had members in 26 countries around the world. The top 5 countries were USA (892 members), India (516), UK (456), Switzerland (190) and Germany (164).

Organizational structure
PhUSE is incorporated in the UK as a non-profit organization and it is run by volunteers. A board of directors is steering the overall direction of the society. New directors are appointed by the board serving a 3 year term. The conferences, events, and working groups are organized by sub-committees.

Annual Conferences
Since 2005 PhUSE has held an annual conference in the following locations:

Computational Science Symposium (CSS)
In 2011 PhUSE and the Food and Drug Administration (FDA) started to collaborate in organizing a joint annual conference. The first annual CSS was held in 2012 in the Silver Spring Civic Center, Silver Spring, Maryland.

The focus of the conference is on collaboration between the FDA, industry, service and solution providers. The collaboration is continued throughout the year in different working groups. Results of the working groups are documented in a wiki environment available to the public.

At the 2014 conference the following CSS working groups were in progress:
 * Optimizing the Use of Data Standards
 * Development of Standard Scripts for Analysis and Programming
 * Non-Clinical Road-map and Impacts on Implementation
 * Emerging Technologies

In 2014 the first Scriptathon was held at the conference. The Scriptathon was organized following the model of Hackathons, which are popular in other industries. The scripts produced during this communal code development event are stored in a open source code repository.

Single Day Events
In 2008 PhUSE started a series of single stream, single day conferences called Single Day Event (SDE) in Europe. In 2010 the SDE series expanded to the US. In 2013 the first single day events were held in India and China. In 2014 a total of 11 SDEs are planned in Europe, the US, and India.

Annual Outstanding Contribution Award
In 2010 PhUSE started to recognize individuals for their outstanding contributions to the PhUSE society. The following people have received the PhUSE outstanding contribution awards:

Relationship to other Societies and Regulatory Authorities
PhUSE has a working relationship with the FDA in the CSS working groups and in organizing the CSS annual conference. PhUSE supports and commented on the Data Transparency Initiative of the European Medicines Agency (EMA) (Reference). PhUSE has a working relationship with the CDISC organization to work on topics like the RDF representation of existing CDISC data standards.

Publications
Between 2008 and 2012 PhUSE published five volumes of a peer reviewed journal called Pharmaceutical Programming (ISSN 1757-0921). In 2013 the first white paper was published by the CSS working group Development of Standard Scripts for Analysis and Programming. The CSS working groups have been issuing white papers and other documentation of their work, e.g. the Analysis Data Reviewer's Guide (ADRG).

In addition PhUSE issues a quarterly newsletter called PhUSE News to its members.