Event Date/Time: Sep 08, 2008 | End Date/Time: Sep 09, 2008 |
Description
Highlights:
• Overview of eCTD readiness at the agencies
• Impact of the eCTD on regulatory processes and procedures
• Practical experience of submitting an eCTD in the EU
• eCTD compilation and life cycle
• Document granularity and readiness
• Regulatory strategy facing technical issues
• Specifications and standards versus regions and procedures.