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RAPS Workshop - Intermediate Course for DMF, ASMF, Module 3 Submissions in eCTD Format (Autumn)


Frankfurt Holiday Inn—Alte Oper
Mainzer Landstraße 27
60329 Frankfurt/Main

If you are currently preparing and maintaining paper ASMFs and DMFs and/or Module 3 in eCTD for the EU, US, Canada and/or Switzerland and have to use the eCTD format, this course is for you.

The FDA’s May 2018 deadline mandates that you comply with the new requirements. The use of eCTD is already mandatory for all for centralised procedure human ASMF submissions from 1 July 2016. To successfully meet these requirements, organizations need to understand the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.
During this workshop, you will learn:

- How structured and transparent the eCTD lifecycle of an ASMF/DMF can be, for EU, US, CA, Switzerland
- What Module 1 documents need to be added
- How structured and transparent the Module 32S and 32P for an applicant are
- How easy eCTDs can be created and maintained
- How to set up gateways with authorities
- How quick eCTDs can be exchanged with the authorities
- How to create a baseline submission
- How to QC and validate an eCTD
- Tips, tricks and best practices gathered from industry professionals
- How to convert from a paper application to an eCTD
- Converting from a paper application to an eCTD
- What CTD readiness really means

We will also provide an overview of the difference between submissions to US, EU, Canada and Switzerland and help you understand how to prepare for each.

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.

For more information, please follow this link.

6 Nov 2017
7 Nov 2017
Frankfurt/ Main, Germany
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