Impact of the eCTD on regulatory processes and procedures
Overview of eCTD readiness at the agencies
ECTD compilation and life cycle management
Practical experience of submitting an eCTD in the EU and GCC
Regulatory strategy facing technical issues
Document granularity and readiness
Specifications and standards versus regions and procedures
Who should Attend
Attendees with responsibilities in:
Dossier Management
Regulatory Affairs
Data Management
Document Management
Electronic Publishing/Submissions
Compliance
Medical Writing
IT/IS EDMS
Regulatory Affairs Agency eSubmission processing and review
Past Events
Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018 - 2018, Dubai, United Arab Emirates (52897)
Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2017 - 10-11 Apr 2017, Four Point By Sheraton Bur Dubai, United Arab Emirates (63495)
Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2016 - 12-13 Dec 2016, Four Point By Sheraton Bur Dubai, United Arab Emirates (63494)
Important
Please, check "Building the eCTD: Practical Approaches to Compiling Electronic Submissions" official website for possible changes, before making any traveling arrangements
