RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Intermediate Course for Regulatory Submissions in eCTD Format - July 2020

10.0
RAC Credits
Thursday, 16 July 2020 (9:00 AM) - Friday, 17 July 2020 (4:00 PM) Eastern Time (US & Canada)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual event. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Effective May 2020, your company is required to migrate all commercial INDs and Master Files, 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 to 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 the US and Rest of the World (ROW), and give you a basic understanding of 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: 16-17 July 2020
Registration Closes: 9 July 2020
Refund Deadline: 16 June 2020*
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 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 2018 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.

NOTE: Students must bring their own laptops to this training session to access materials provided on the USB port provided.


Speakers

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

Marianne Mowrer, regulatory submissions specialist, Mentara Inc.


Registration to 16 June 2020
RAPS Members: $900
Nonmembers: $1,000

Registration from 17 June to 9 July 2020
RAPS Members: $1,000
Nonmembers: $1,100

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.

Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.


Other Information

Cancellation

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  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.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event. 

Program Contact

Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, ext. 291

Register