RAPS Workshop: Introduction to eCTD: Structuring Your First CTD-based Submission (April 2024)

To successfully meet electronic Common Technical Document (eCTD) submission requirements, organizations must understand the underlying Common Technical Document (CTD) structure. In addition, participants will receive suggestions for implementing changes to support successful electronic regulatory applications. During this workshop, you will learn:

• Different submission types
• Which applications need to be submitted electronically
• How to understand and follow the CTD structure
• How to use the M4 guidance series and granularity to generate compliant submissions
• Agency-compliant PDF files, and how to generate them
• Which agency guidelines and technical specifications publishers need to follow
• What tools are required to submit your applications electronically?

Registration Fees & Deadlines

Learning Objectives

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

• Understand the acronyms and terms relevant to electronic submissions.
• Break down the CTD structure using the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use M4 guidance in preparation for eCTD

Who Should Attend?

The program is a boot camp for regulatory professionals who need basic knowledge of the CTD format.

This workshop is beneficial for professionals — particularly medical writers, regulatory operations professionals, and submissions-publishing specialists — working in the drugs, biologics, or combination products fields and involved in preparing electronic submissions. There are no prerequisites for participation.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Speakers

Marianne Mowrer
Regulatory Operations consultant, Professional eSubmission Services, Inc

Marianne Mowrer is a Regulatory Operations consultant working with her own group, Professional eSubmission Services, Inc., as well as Mentara, Inc., and other consulting groups. She has mor than 20 years of experience preparing documents and regulatory submissions for the domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted more than 1,000 submissions to regulatory agencies, all without a single refuse-to-file. Her group enjoys an exceptional record of meeting critical deadlines, and for streamlining and managing the complex process of creating documents from multiple authors and contributors, and generation of agency-compliant PDF files.

Nora Keeling
QA/Regulatory Submissions Consultant, Professional eSubmission Services, Inc

Nora Keeling has more than eight years of regulatory operations and FDA submissions quality control experience, including hands-on experience with numerous CTD and eCTD submissions. She works as an independent consultant with her own team, Professional eSubmission Services Inc., as well as part of the Mentara, Inc. consortium. She has participated in successful project management, document processing, compilation, and submission of numerous eCTD sequences. Keeling is responsible for formatting quality control, ensuring documents meet regulatory specifications, as well as quality control-submission compilation.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions