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RAPS Workshop - Regulatory Submissions in eCTD Format

Apr2017
12

LORENZ has again been selected as RAPS's vendor of choice to support their eCTD workshops. Workshop attendees will be accessing LORENZ's cloud environment to use LORENZ docuBridge in real time as they learn about eCTD concepts taught by Marianne Mowrer.

Location:
RAPS Headquarters Office
5635 Fishers Lane
Suite 550
Rockville, Maryland 20852

Description:
Do you need to comply with the May 2017 electronic submission requirements? Here's what to do.

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 processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

- Which types of applications need to be submitted electronically
- What agency-compliant PDF files are
- Which agency guidelines publishers need to follow
- How metadata and study tagging files work
- How to compile documents into the XML backbone of an eCTD
- What is required to electronically submit your applications

We will also discuss European, Canadian, and US guidelines, and help you understand how to prepare for each region.

Join us for this 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.


From:
12 Apr 2017
To:
13 Apr 2017
Location:
Rockville, Maryland, United States
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