Intermediate Course for Regulatory Submissions in eCTD Format - October 2021

12.0
RAC Credits
Thursday, 14 October 2021 (9:00 AM) - Friday, 15 October 2021 (4:00 PM) Eastern Time (US & Canada)

Do you have a working knowledge of the CTD structure and need to learn how to correctly apply it to electronic submissions? Or do you need to know what is required to comply with the FDA’s May 2020 guidances? If you already have a working knowledge of the CTD structure and …

 

·            Need to learn how to correctly apply this structure to electronic submissions

·            Need an understanding of eCTD to work with your team or vendors

·            Need a better understanding of eCTD to effectively plan submissions

·            Want to learn different strategies and tips for using metadata effectively for future lifecycling

·            Want to learn submission organization strategies

·            Or, just need to know what is required to comply with the FDA’s May 2020 electronic submission requirements... then this course is for you.

 

Effective May 2020 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

 

How to comply with the May 2020 electronic submissions requirements

  • Which agency guidelines and technical specifications publishers need to follow
  • How to apply ICH and regional requirements to your eCTD
  • How to compile documents into the XML backbone of an eCTD, and lifecycle that application
  • How to QC and validate an eCTD
  • How metadata and study tagging files work
  • Tips, tricks and best practices gathered from industry professionals
  • How convert from a paper application to an eCTD
  • How the new Module 1 (version 3.3) can be used for regulatory submissions
  • What CTD readiness really means
  • We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ.

 

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

 

Program Dates: 14-15 October 2021

Registration Closes: 7 October 2021

Refund Deadline: 14 September 2021*

RAC Credits:        10 RAC recertification credits upon completion of the program

Proof of Attendance:       An electronic letter of attendance will be sent upon request.

*Please see the cancellation policy below.

 

Objectives

At the conclusion of this program, participants will be able to:

  • Identify best practices with the software used to generate electronic submission content
  • Understand the acronyms and terms surrounding eCTD and electronic submissions
  • Apply ICH and regional requirements for the content of an eCTD submission
  • Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA.
  • Obtain an understanding of what is required to transition into submitting in the eCTD format.

 

Who Should Attend

This intermediate-level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 2020 FDA electronic submission deadline.

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, and submissions publishing.

 

Agenda

  • How to comply with the May 2020 electronic submission requirements
  • Guidances that govern electronic submissions
  • How to electronically submit to FDA
  • Generating compliant PDF files—best practices in MS Word and Adobe Acrobat
  • Hands-on compilation of an eCTD
  • Module 1 differences between US and Rest of World
  • Creating the initial sequence of an application
  • Assigning the metadata required by the regional authority and ICH
  • Lifecycling the application
  • Publishing and validating the application
  • Compiling will include:
  • Study Tagging Files (STFs)
  • Datasets
  • SPLs (Structured Product Labeling)
  • Granulated Clinical Study Reports (gCSR)
  • Challenges with preparing compliant eCTD submissions
  • Review and QC of the compiled application
  • Common and avoidable errors that could get your submission rejected
  • Tips, tricks, and best practices gathered from industry professionals
  • Converting from a paper application to an eCTD application
  • What eCTD readiness really means

 

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.

 

1 January – 14 September 2021: Early Bird $800.00 Members | $900 Nonmembers

15 September – 7 October 2021: Regular $900.00 Members | $1,000 Nonmembers

 

If it is your preference, please use the registration form 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. Contact Stephany Evans

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA