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This program sponsored by
2–4 May 2012
The hotel block is limited for this workshop. In order to facilitate easier travel to Washington, DC, this workshop will start at 12:00 pm on Wednesday, 2 May. East coast attendees can minimize their time out of the office and save money on a hotel night by arriving on 2 May.
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research has required electronic submissions in electronic Common Technical Document (eCTD) format since 1 January 2008. In the most recent version of the Prescription Drug User Fee Act (PDUFA V) and the Generic Drug User Fee Act (GDUFA), FDA has implemented incentives for industry to submit Investigational New Drug applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) in eCTD format, with mandatory eCTD format for INDs, NDAs and BLAs during the PDUFA V timeline. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMA) has required eCTD format for Centralised Procedure applications since 1 January 2010. Individual health authorities in Europe implemented all electronic review environments 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. All regulatory authorities are refusing to accept eCTDs for review that fail technical validation standards. Agencies have announced their intent to enhance their validation standards in 2012 and refuse to accept more submissions for noncompliance.
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 for FDA, repurposing the content for submission to EMA, and the challenges and benefits of using document granularity over a drug submission’s lifecycle. Expert instructors will teach participants about the detailed contents of all modules of the eCTD, the differences in Module 1 for the US, Canada, and Europe, 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 participating in this workshop, you will not only learn how to strategically prepare submissions for US, Europe, and Canada health authorities, but you will assess and improve submission processes, workflow and teamwork to achieve less stress and cost to your organization.
At the conclusion of this workshop, participants should be able to:
- Describe the differences in regional requirements for FDA, Health Canada, EMA and EU health authorities
- 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
- Hands-on eCTD publishing experience
- Compile an eCTD application with multiple submission sequences in compliance with US FDA guidances and specifications
- Clone the submission sequences for modification to comply with EMA eCTD specifications for Centralised Procedure
- Validate and view the applications against relevant ICH and agency guidances and specifications
This advanced eCTD workshop is beneficial for professionals working in drugs or biologics—preparing INDs, DMFs, ANDAs, NDAs, BLAs and Marketing Authorisaton Applications—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