Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Principal Consultant
Industry
Medical / Health Care / Pharmaceuticals
Website
http://www.gene.comAbout
Goal:
To help bring safe and effective medicines to patients through the automation of the drug development process, focusing on the electronic exchange of information between sponsors and health authorities by developing and implementing global healthcare standards.
Experience:
30+ years in Biotech/Pharma, 10+ years in Regulatory Systems Expertise and Interest:
• Structured component-based authoring
• Clinical Document Architecture (HL7 CDA)
• Document Management Systems
• DIA EDM Reference model
• Submission Publishing (eCTD, RPS)
• Standards Development Organizations
• HL7, CDISC, ISO 251, CEN 215
• Semantic Search Technologies
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