Preparing Compliant eCTD Submissions

RAPS Training Center
Rockville, Maryland, USA
7–8 August 2008

A RAPS interactive seminar and hands-on workshop—learn by doing

Capacity for this program has been reached and registration is now closed. On-site registrations will not be accepted. If you would like to be added to the waitlist should any cancellations occur, please contact the Solutions Center at +1 301 770 2920, ext. 200. Thank you..

Program Description

The electronic Common Technical Document (eCTD) format for electronic submissions is rapidly becoming the required standard of regulatory authorities around the world. FDA has mandated the eCTD format for electronic submissions to the Center for Drug Evaluation and Research (CDER) starting 1 January 2008. The European Union has declared that its 27 Member States must be capable of accepting electronic-only marketing applications in eCTD format by 2009 and Health Canada has implemented an electronic review environment for eCTD submissions.

In this hands-on eCTD readiness training workshop, participants roll up their sleeves for two full days of skill building, interactive exercises, case studies and small group discussions. This workshop provides a detailed, technical overview of the tools, techniques and processes required to prepare for eCTD submission. All eCTD production options, including outsourcing to submission publishing services, or selecting and implementing a publishing system are discussed. It reviews the impact of managing submission content throughout the eCTD lifecycle on electronic document management systems. Participants learn XML competency level requirements as well as where FDA is headed with the next eCTD generation–the Regulated Product Submission (RPS).

In order to participate in the interactive components of this workshop, you will need to bring a laptop capable of connecting to the Internet via a wireless card; hard-wired connections are not available. If your laptop uses an operating system other than Windows XP, please contact Melinda Contreras for additional technical assistance.

Learning Objectives

Summarize Canadian and US requirements for electronic submissions, including eCTD, SPL, PIM and CDISC
Articulate how the agencies perform reviews on electronic submissions

Who Should Attend?

This program is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in preparing electronic submissions, particularly medical writers, regulatory operations, submissions publishing and IT staff.

Levels: Levels II, III, IV

Instructor

Antoinette Azevedo founded e-SubmissionsSolutions.com in 2000 to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Her clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Azevedo is a world-renowned expert in the tools, techniques, processes and vendors involved in producing eCTDs and the supporting technical infrastructure, including electronic document management systems and submissions publishing outsource services.

Key Program Goals

Evaluate your company's technical and staff resources as well as its business policies concerning records and document management.
Explore best practices while gaining hands-on experience with software used to generate electronic submission content (MS Office & Adobe Acrobat).
Effectively produce and review eCTDs to minimize the chance of Refuse-To-File (RTF) action by FDA.
Learn about the leading eCTD publishing systems.
Decipher acronyms and master the jargon surrounding eCTD and electronic submissions.

Company Literature Display Opportunities

Attendees of the RAPS eCTD workshops will be mid to high level professionals looking for a comprehensive understanding of the tools, techniques and processes required to complete an eCTD submission. Displaying information at the workshops will help your company generate recognition and product exposure to industry decision makers. Benefits include:

Promote your company to the targeted audience.
Display company literature at each of the three eCTD session.
Spotlight your company in the seminar program and on the RAPS website.

For display pricing and details, email advertising@raps.org or call +1 301 770 2920, ext. 244.