Introduction to Regulatory Submissions in the eCTD Format - October 2021

12.0
RAC Credits
Monday, 11 October 2021 (9:00 AM) - Tuesday, 12 October 2021 (4:00 PM) Eastern Time (US & Canada)

To successfully meet electronic Common Technical Document (eCTD) submission requirements, organizations need to understand the underlying Common Technical Document (CTD) structure upon which electronic submissions are built. In addition, participants will get suggestions for implementing operational 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 series of guidances 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

 

 

* Please see the cancellation policy below.

 

Objectives

 

After this program, participants will be able to:

·        Understand the acronyms and terms relevant to electronic submissions

·        Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD

·        Identify best practices with software used to generate electronic submission content

·        Produce MS Word and PDF documents that meet FDA guidelines

·        Obtain a basic understanding of what is required to transition to submitting in the eCTD format

 

Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance.

 

 

Who Should Attend

 

The program is a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions.

 

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

 

Agenda

·        Define important terminology used in e-submissions

·        Provide a detailed breakdown of the CTD structure

·        Understand the M4 series of guidance (ICH) and FDA technical specifications

·        Learn how to create FDA-compliant MS Word documents

·        Learn how to create FDA-compliant PDF documents from differing sources

·        Review the workflow process using planners to produce an eCTD

·        Learn how to convert from a paper application to an eCTD application

·        Learn the basics of managing an electronic submissions project

·        Review the entire lifecycle of an electronic submission from first steps to eCTD

·        Learn tips, tricks, and best practices

·        What does eCTD readiness mean?

NOTE: Program content may vary.

 

Speakers

Marianne Mowrer, regulatory submissions specialist, Mentara 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 20+ years’ experience preparing documentation and regulatory submissions for domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted over 1,000 submissions to multiple 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 document creation from multiple authors and contributors, and generation of Agency-compliant PDF files for submission.

Nora Keeling, MS, QC, regulatory submission consultant, Mentara Inc.

Nora Keeling, M.P.A., has over eight years of experience in regulatory operations and FDA submissions Quality Control (QC), 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 the successful project management, document processing, compilation and submission of numerous eCTD sequences. Nora is responsible for formatting QC, ensuring documents meet regulatory specifications, as well as submission compilation QC.

 

 

Program Dates:

11-12 October 2021

 

Registration Closes:

4 October 2021

 

Refund Deadline:

11 September 2021*

 

RAC Credits:

8 RAC recertification credits upon completion of the program

 

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

 

Pricing/Deadlines

18 December 2020 – 11 September 2021: $800 Members | $900 Nonmembers

12 September – 4 October 2021: $900 Members | $1,000 Nonmembers

 

 

If it is your preference, please use the registration form link below to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.

 

Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.

Additional Information (who to contact, special instructions)

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.