eCTD preparation and submission
Editing documents - creating a baseline - submitting the eCTD
- Screening and editing essential marketing authorisation documents
- Efficient baseline creation
- eCTD compilation and submission
- Flexible time and place
- Multiple-choice tests and personalised certificate
- Intuitive Learning platform
Aims and objectivesDo you need practical expertise in editing essential marketing authorisation documents and compiling an eCTD? Do you need to make a baseline submission and thus seek practical advice?
This e-Learning consisting of three recorded webcasts will show you step by step how to develop the relevant documents, compile them and submit an eCTD.
Learn all about eCTD submissions at your own pace, anywhere and at any time.
Acknowledgement: These webcasts were recorded in the course of the 'eCTD in the Middle East' live webcast series in April 2019.
- 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 eCTDs for drug substances
- Step-by-step guide to baseline submissions
- Mandatory and optional scope of baselines
- Identifying the currently valid version of your documentation
- Best practice for eCTD compilation, submission and review
- Typical validation issues and how to avoid them
- Best practice: Practical short exercises
Director, Principle Consultant Regulatory Operations
Nähere Informationen finden Sie hier.
Upon completing this programme, you will:
- be able to develop an eCTD;
- be knowledgeable of eCTD compilation, submission and revision; and
- be able to make a baseline submission in the eCTD format.
The online training programme "eCTD preparation and submission" comprises three didactic modules in which the expert share his expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the three modules and passed the multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
1. Register for an e-learning programme on our website.
2. You will receive an email with your login data for our learning platform.
3. Log in to start your e-learning programme.
4. Complete your e-learning modules at your own pace.
5. Finalise the modules with a multiple-choice test.
6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out.
Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.
Erhalten Sie in drei Tagen umfassendes Wissen im Indikationgebiet Onkologie: Von der klinischen Entwicklung über die Arzneimittelzulassung und Pharmakovigilanz bis hin zur onkologischen Versorgung.
10. - 12.12.2019 in Köln
This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
13.02.2020 in Frankfurt
After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
17. - 18.02.2020 in Frankfurt
Two experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes.
17.03.2020 in Frankfurt
CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
18.03.2020 in Frankfurt