Preparing Compliant eCTD Submissions

Roll up your sleeves for a two-day unbiased introductory workshop comprised of skill building, interactive exercises, case studies and small group discussions to learn how to prepare an effective electronic Common Technical Document (eCTD) submission on any platform.

Every regulatory professional should know the standards, groundwork, expertise and technology required to submit an electronic submission within the US and globally. Due to its cost effectiveness, and because it guarantees a faster response from the recipient regulatory agency, reducing time-to-market, the eCTD has become the standard for numerous regulatory agencies around the world.

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 (EMA) has required eCTD format for Centralised Procedure applications since 1 January 2010. Some regulatory authorities in Europe have implemented only electronic review environments and are now refusing to accept paper submissions. 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 prevent the authorities from conducting their review.

What makes the RAPS eCTD training unique? Gain from:

• An introduction to EU submissions using the eCTD format
• A critical comparison of how EU and US submissions differ
• Tips on successful integration methods for eCTD culture within your department
• Instructor-led, hands-on exercises in best practices in MS Word and Adobe Acrobat Professional
• A step-by-step demonstration creating an eCTD project, settting submission metadata, linking documents and setting content metadata, and creating lifecycle sequences*
• Working session on conducting an eCTD Readiness Assessment

Put yourself and your company a step ahead of competitors by mastering the eCTD. Several previous similar programs have sold out, so register today!

Learning Objectives

At the conclusion of this workshop, participants should be able to:

• Identify fundamental strategies for preparing to submit eCTD submissions
• Explain how eCTD differs from previous electronic submission formats and the technical requirements of an eCTD submission
• Discuss the content of the technical modules and demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
• Submit a US eCTD that is compliant with CDER’s requirement, as well as an EU eCTD
• Facilitate the transition to electronic submissions within your organization

Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting life sciences practice. Azevedo's experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.

* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.

** Multiple registration fees require three or more participants from the same company to submit individual registration forms at the same time via fax, mail or email to the RAPS Solutions Center. Individuals requesting the government/nonprofit rate must submit their completed registration form by fax or email.

Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 13 July 2011 unless meeting capacity is reached; after 13 July 2011, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 27 June 2011