e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013 is a webinar that covers topics such as:
- 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
e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013 brings together:
- 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