Intermediate Course for Regulatory Submissions in eCTD Format - October 2020

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 …

... 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.

• 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.

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.

• 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.

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.