FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
e-Learning: Common Technical Document & eCTD
Common Technical
Document & eCTD
e-Learning
2018-12-17 2018-12-17 an Ihrem Arbeitsplatz Online

e-Learning: Common Technical Document & eCTD

including CMC requirements for marketing authorisation applications

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
Topics
  • CTD principles and structure
  • Format and content of Module 1 - 5 CTD
  • CMC data required for Module 3 (drug substance and drug product)
  • Dossier requirements for generics and further abridged procedures
  • Dossier requirements for ASMF and CEP submissions

This distinguishes our event

4
Modules
5
Hours of learning content
4
Controls of success
24
Hour access to your personal learning environment on every day

Aims and objectives

This e-Learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.

It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type.
Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).

This e-Learning was developed in July 2018.

Who should attend
Do you need expertise in CTD and eCTD? Then this e-Learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required. It can be also used as a refresher course providing in depth knowledge with regards to CMC requirements.
Your speakers
Lidia Cánovas
ASPHALION S.L., Barcelona, SPAIN

Michael Schaub
ASPHALION S.L., Munich, GERMANY


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