You will find all the important information you need to complete the e-Learning programme here.
Speaker: Karl-Heinz Loebel
Content:
- eCTD document authoring and technical preparation –structures and processes to develop documents suitable for the eCTD
- Granularity, bookmarks and hyperlinks – options and requirements
- The eASMF – reduced scope eCTD for drug substances
Speaker: Karl-Heinz Loebel
Content:
- Step-by-step guide to baseline submissions
- Mandatory and optional scope of baselines
- Identifying the currently valid version of your documentation
Speaker: Karl-Heinz Loebel
Content:
- Best practice for eCTD compilation, submission and review
- Typical validation issues and how to avoid them
- Best practice: Practical short exercices
Please complete the Online-Test to receive your certificate.
