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Introduction to Electronic Regulatory Submissions in the eCTD Format - July 2020

8.0
RAC Credits
Tuesday, 14 July 2020 (9:00 AM) - Wednesday, 15 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.

The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to 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 electronically submit your applications

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

Program Dates: 14-15 July 2020
Registration Closes: 7 July 2020
Refund Deadline: 14 June 2020*
RAC Credits: 8 RAC recertification credits upon completion of the program
Proof of Attendance: An electronic letter of attendance will be sent upon request.
Registration Fees: Registration to 14 June 2020
RAPS Members: $800
Nonmembers: $900

Registration from 15 June to 7 July 2020
RAPS Members: $900
Nonmembers: $1,000
*Please see the cancellation policy below.

Objectives

After this program, participants will be able to:

  • Understand the acronyms and terms surrounding 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 into submitting in the eCTD format

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 to meet the fast-approaching FDA electronic submission deadlines for eCTD in May 2020.

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. 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.

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

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