e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013

Topics

• Submission Requirements & Guidances, FDA
• Overview: Approval Process for Drugs, Biologics and Devices
• E-Submissions, EMEA, EU and globally
• Electronic Regulatory Submission & Gateway, FDA
• Electronic Common Technical Document (eCTD), ICH
• International Conference on Harmonization (ICH)
• Health Level 7 Regulated Clinical Research Information Management
• ECTD Guidance and Specifications, FDA
• Biomedical Research Integrated Domain Group(NIH, FDA, CDISC, HL7)
• Clinical Data Interchange Standards Consortium, (SDTM, SEND, ADAM)
• Benefits and Challenges with Data Standards worldwide

Who should Attend

• Policy analysts
• Management (Pharma, Biotech)
• Health IT Managers and Analysts
• Government officers
• Regulatory Affairs personnel
• Research and Development (Pharmaceutical, Academia)
• Auditors and inspectors
• Quality assurance/quality control personnel
• Entrepreneurs Investors