New Task Force on Semantic Web for Drug Safety and Efficacy

ANNOUNCEMENT:

A New Task force has been created to discuss how best to use semantic  
web standards to "R&D Informatics applied as part of Drug Safety and  
Efficacy". Specifically, this task force will focus on the following  
areas for scenarios and activities:
Identify/address challenges and needs regarding Biomarkers and  
Pharmacogenomics in coordination with FDA guidelines
Semantic applications around Drug Safety: Signals and Notification
Possible applications of Semantic Web in Clinical Trial planning,  
management, analysis, and reporting (e.g., EDC and EHR Single-Source,  
data security, integrity)
Facilitating electronic submissions as per the Common Technical  
Document (eCTD) specifications, http://www.fda.gov/cder/guidance/ 
7087rev.htm

The use of information to improve the development of Efficacious and  
Safe Drugs rests on the proper and timely utilization of diverse  
information sets, and the adoption and compliance to well-defined  
policies. As information becomes more diverse and policies more  
central to the industry, the development of information systems that  
are better suited to handle multiple information types (data and  
ontologies) while complying to defined policies (rules and actions)  
will become essential. Semantic Web technology standards offer  
potential solutions for:
Aggregating Study Datasets, around Biomarkers (and following eCTD  
guidelines)
Enhancing management of non-clinical and clinical controlled  
vocabularies that will be certainly expanding and evolving  
(adaptability)
Providing fast access to current safety information though semantic- 
enabled channels (Pharmacovigilance)
Applying Rules, Integrity, and Security in support of policy  
compliance and management (HIPAA, CFR21Part11 and Sarbanes-Oxley)

This activity is open to mailing list participants and W3C members  
who are interested in this area. More information can be found at:
http://esw.w3.org/topic/HCLSIG/Drug_Safety_and_Efficacy

cheers,
Eric



Eric Neumann, PhD
co-chair, W3C Healthcare and Life Sciences,
and Senior Director Product Strategy
Teranode Corporation
83 South King Street, Suite 800
Seattle, WA 98104
+1 (781)856-9132
www.teranode.com