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A RAPS interactive workshop!
Hilton San Diego/Del Mar
Del Mar, CA, US
29 September-1 October 2010
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 1 January 2008 and as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV) is implementing a single electronic review environment for all FDA Centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMEA) has required eCTD format for Centralized Procedure applications since the beginning of this year (1 January 2010. Some regulatory authorities in Europe have implemented all electronic review environments ahead of this deadline and are refusing to accept paper submissions for review. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance with the electronic format and difficulty navigating the electronic files that comprise an eCTD, which are preventing them from conducting their review.
Designed to build upon the foundation provided in RAPS’ Preparing Compliant eCTD Submissions Workshop, this interactive, hands-on advanced training seminar will provide the experience of compiling an eCTD submission in the research and development phase, repurposing the content for submission to multiple regulatory authorities, and the challenges and benefits of using document granularity over a drug submission’s lifecycle. Region-specific experts will teach participants about the detailed contents of all modules of the eCTD, the differences in Module 1 for the US, Canada, Europe, and Japan, and how regional differences impact Modules 2 through 5. Attendees will also learn how eCTD submissions in the research and development phase differ from those for marketing applications.
By taking this course, you will not only know how to strategically prepare submissions in the US, Europe, Canada, and Japan, but you will assess and improve submission processes, workflow, and teamwork to achieve less stress and cost to your organization.
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Describe the differences in regional requirements for FDA, Health Canada, EMEA, and MHLW.
- Use granularity in document content to prepare INDs in eCTD format
- Use granularity and lifecycle to prepare marketing applications in eCTD format
- Develop a table of contents for an eCTD submission with a goal of simultaneous global submissions
- Understand the direction global regulatory authorities are taking to standardize on the eCTD format and the strategic implications for their companies
NEW FOR 2010!
- Hands-on eCTD publishing experience!
- Compile an eCTD application with multiple submission sequences in compliance with US FDA guidances and specifications
- Clone the submission sequence 0000 for modification to comply with EMEA eCTD specifications for Centralised Procedure
- Validate and view the applications against relevant ICH and agency guidances and specifications.
Audience Level
This advanced eCTD workshop is beneficial for professionals working in drugs or biologics and who have had experience preparing electronic submissions using formats prior to the eCTD standard, particularly medical writers, regulatory operations, submissions publishing and IT staff. It is intended for individuals who have attended one of RAPS’ Preparing Compliant eCTD Submissions Workshops or have prior experience with earlier generations of submission publishing.
Professional Levels: Intermediate
Product Coverage: drugs & biologics & veterinary
Geographic Coverage: Europe, US, Canada, Japan
In an effort to best manage the user experience for this hands-on workshop, laptops will be provided for all attendees. Personal laptops will not be allowed as substitutes during these sessions.