Preparing Compliant eCTD Submissions

RAPS Training Center
Rockville, MD

Get hands-on training at this two-day, intensive workshop. Benefit from skill-building, interactive exercises, case studies and small group discussions, and learn how to prepare effective electronic Common Technical Document (eCTD) submissions for the US and EU markets.

Every regulatory professional should know the content, processes, standards, and technology groundwork, to develop the expertise required to submit a compliant eCTD submission to the US and global health authorities. Due to its cost effectiveness, and because it provides a faster review environment for the recipient regulatory agency, reducing time-to-market, the eCTD has become the standard for regulatory agencies around the world.

With the FDA Safety and Innovation Act (FDASIA), FDA has been granted statutory authority to require use of the eCTD format for IND, ANDA, NDA, BLA submissions. The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has required electronic submissions in eCTD format since 1 January 2008. 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 electronic-only 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 the eCTD format
• A critical comparison of how EU and US submissions differ
• Tips on successfully integrating the eCTD culture within your company and regulatory affairs 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 eCTD submissions, including outsourcing vs production in-house
• 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
• Verify that a US eCTD that is compliant with CDER and CBER requirements, as well as an EU eCTD
• Facilitate the transition to electronic submissions within your organization, including communicating the roadmap to transition to successful eCTD production to meet the looming FDA mandates

Who Should Attend?

This program is intended for entry to mid-level regulatory professionals who want or are required to become more familiar with the role, benefits and challenges of eCTD submissions.

The material 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. There are no prerequisites to participate.

Instructor

Antoinette Azevedo founded e-SubmissionsSolutions.com 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’s life sciences practice. Azevedo's experience ranges from developing strategies for document management and electronic publishing, implementing fully-validated systems, to staff augmentation and eCTD publishing services resulting in submissions accepted by regulatory authorities worldwide.

Key Program Goals

• Explore best practices with software used to generate electronic submission content (MS Office & Adobe Acrobat).
• Decipher acronyms and master the jargon surrounding eCTD and electronic submissions.
• Navigate technical requirements of the content of an eCTD submission.
• Transition your company into submitting in the eCTD format for both IND stage submissions as well as marketing applications
• Effectively produce and review eCTDs to minimize the chance of Review and Refuse to File (RTF) action by FDA.
• Learn about EU submissions and procedures and how eCTD is different in the US and the Europe

* RAPS does not endorse any publishing systems or vendors. All eligible systems have been placed in a rotation pool and will be demonstrated upon its turn.