A full day focused on eCTD Training, that will bring together the two groups of players in Pharma: “Authority” and “Industry”
You have an opportunity to work together in groups on training submissions along with a typical eCTD scenario, learning through role-play and practical application.
Delegates will learn and discuss the needs of their counterparts and achieve a common understanding of the eCTD process, using the EXTEDO suite.
eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities.
It provides a harmonized solution to implement the Common Technical Document (CTD) electronically.
An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure. It also has an XML backbone which cross-links required documents and provides information regarding the submission.
The purpose of introducing eCTD is to reduce the burden on the reviewers and to simplify the process of submission to Regulatory authorities
RCC Business Consultant at EXTEDO
Since 2017 Michael supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.
Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than six years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.
EXTEDO – Workshop Sponsor – Interview:
Mr. Michael Faust
RCC Business Consultant, EXTEDO
| Time | Topic |
| 09:00 – 09:15 | Welcome |
| 09:15 – 10:00 | Introduction to eCTD |
| 10:00 – 11:00 | eCTD Basics and Regional Information, QC/ VAL, BP |
| 11:00 – 11:15 | Coffee Break |
| 11:15 – 12:45 | eCTD Role Play – Part 1 – Tool overview, QC and Basic Reviewing |
| 01:00 – 02:30 | Prayer & Lunch Break |
| 02:30 – 03:30 | eCTD Role Play – Part 2 – Managing Submissions and Advanced Review |
| 03:30 – 04:15 | Advanced eCTD – XML backbone and eCTD 4.0 |
| 04:15 – 04:30 | Q&A and Closing |
| 04:30 – 05:00 | (Optional, if required) |
BOOK BY 10th of FEBRUARY 2023
to get the early bird price
All participants should bring their laptop in order to participate in the hands-on parts of the training.
راعي
عارض
Sponsor
Exhibitor
