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:
鈥� Structured component-based authoring
鈥� Clinical Document Architecture (HL7 CDA)
鈥� Document Management Systems
鈥� DIA EDM Reference model
鈥� Submission Publishing (eCTD, RPS)
鈥� Standards Development Organizations
鈥� HL7, CDISC, ISO 251, CEN 215
鈥� Semantic Search Technologies
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