12:00CAT – 16:00CAT
For all Delegates of AfriSummit
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.
Mr. Frank Dickert
Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry.
In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures.
In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with regards to the respective tool.
Dr. Gerhard Neurauter
Gerhard leads the Regulatory Competence Center at EXTEDO GmbH in Munich, Germany, which serves as the backbone for EXTEDO’s regulatory competence and ensures the life sciences business operates compliant. Gerhard is responsible for all aspects of regulatory intelligence at EXTEDO which includes eCTD, IDMP, PV, PP… and supports EXTEDO to explore new innovations and markets. Gerhard joined EXTEDO in 2002. With now more than 25 years of life sciences industry expertise, he has a deep understanding of the underlying regulatory business processes of the pharmaceutical industry and the national competent authorities. Gerhard graduated in analytical chemistry at the Karl-Franzens-University of Graz, Austria and holds a doctorate degree from the University of Regensburg, Germany.
12:00 – 12:15 Welcome
12:15 – 13:00 Introduction to eCTD
13:00 – 13:15 Q&A
13:15 – 14:15 eCTD Basics
14:15 – 14:30 eCTD Live Demo Q&A
14:15 – 14:30 Take a Break
14:30 – 15:15 Regional Info
Paper to eCTD
QC/ VAL, BP
15:15 – 15:30 Q&A
15:30 – 15:50 eCTD in South Africa
15:50 – 16:00 Q&A and Closing