You will find all the important information you need to complete the e-Learning programme here.
Content:
- ICH and the origin of the CTD
- General aspects of the CTD
- EU legislation - Eudralex - Notice to applicants
- CTD Modules 1-5
- electronic CTD = eCTD
Learning objectives:
After having passed this module...
- you understand the CTD structure
- you know the eCTD necessities
Content:
- Information "flow" in the CTD triangle
- Module 1 - Regional and Administrative documents (EU focus)
- Module 2 - Overviews and Summaries
- Module 3 - Quality (headings only)
- Module 4 and 5 - Study Reports
Learning objectives:
After having passed this module you know where to include which data in the CTD dossier.
Content:
- Application Types
- Data Exclusivity
- Article 8(3) Full Application
- Article 10: Generic, Hybrid or Similar Biological Applications
- 10a Well Established Use Applications
- 10b (New) Fixed Dose Combinations
- 10c Informed Consent Application
- 16a Traditional Use Registration for herbal medicinal product
Learning objectives:
After having passed this module...
- you have a deep understanding of the possible legal basis for marketing authorisations in Europe
- you know which legal basis might be applicable to your product
Content:
Module 4a: Introduction
- CTD Module 3 structure
- Guidelines applicable
Module 4b: Drug Substance
- CTD Module 3 drug substance data requirements
Module 4c: ASMP & CEP
Module 4d: Drug Product
- CTD Module 3 - drug product data requirements
- Appendices and Regional Information
Learning objectives:
After having passed this module...
- you have a thorough understanding of the CMC part of the marketing authorisation dossier
- you know how to fill in module 3 of the CTD
