Event Details

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.

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 5, 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, and options available, 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 and how to incorporate them into your workflow and QC
• How to apply ICH and regional requirements to your eCTD
• What your publishers need from you to compile documents into the XML backbone of an eCTD, and to lifecycle that application
• How to QC and validate an eCTD
• How metadata and study tagging files work, and how you can make them work for you and your application
• 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
• How to generate and use an effective planner
• What CTD readiness really means

We will also provide a brief overview of the difference between submissions to US and the Rest of the World (ROW) and give you a basic understanding how the regions differ.

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

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 how MS Word functionality can be used to reduce the need for PDF remediation to produce an FDA-compliant PDF file
• Generate a submission planner/document tracker and folder structure to manage documents and workflow
• 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 those with a working knowledge of the CTD format who are already preparing documents for FDA submissions. The program is a boot camp for regulatory professionals who need to comply with the May 5, 2020 FDA electronic submission deadline.

This workshop is beneficial for professionals working in the drug, biologic or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, technical writers, regulatory operations, regulatory affairs, and submission planners.

Agenda

• How to comply with the May 2018 electronic submission requirements
• Guidance that governs electronic submissions
• How to electronically submit to FDA
• Generating compliant PDF files—best practices in MS Word and Adobe Acrobat
• Compilation demonstration of an eCTD
• Module 1 differences between US and the 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
• Organizing workflow for efficiency and accuracy
• What eCTD readiness really means

NOTE: Program content may vary.

Speakers:

Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc.
Marianne Mowrer, regulatory submissions specialist, Mentara Inc.

Registration from 26 February to 25 March 2020

RAPS Members: $1,000
Nonmembers: $1,100

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.

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. 

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

Program Contact

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