e-Learning: Common Technical Document and eCTD
including CMC requirements for marketing authorisation applications
- Up-to-date expert knowledge
- Flexibility in location and timing
- Compatibility with mobile devices
- Tests & certificate of completion (*)
- Officially certified to ISO 9001 and ISO 21001
e-Learning
Ab
590,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 590,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Buchungsdetails
e-Learning
Ab
590,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 590,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
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.
Your speakers
Lidia Cánovas
ASPHALION S.L.,
Barcelona, SPAIN
General Manager, Regulatory Affairs Director;
Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical…
Your speaker
Lidia Cánovas
ASPHALION S.L.,
Barcelona, SPAIN
General Manager, Regulatory Affairs Director;
Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.
Michael Schaub
ASPHALION S.L., Munich, GERMANY
Director Munich Office
Michael has broad experience in European, FDA and RoW registration procedures. He has acquired specialist knowledge in the implementation of…
Your speaker
Michael Schaub
ASPHALION S.L., Munich, GERMANY
Director Munich Office
Michael has broad experience in European, FDA and RoW registration procedures. He has acquired specialist knowledge in the implementation of eSubmission standards, the regulatory support for innovative products such as biologicals, biosimilars and ATMPs, as well as the preparation of paediatric investigation plans. Nowadays, his responsibilities include the strategy and the management of international drug registration procedures, evaluation of the respective dossiers as well as carrying out scientific advice procedures and presubmission meetings with international regulatory authorities.
What to Expect
- 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
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.
Objective of the Event
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 completely revised in August 2025.
Your Benefit
- Up-to-date expert knowledge & flexibility in location and timing
- Comprehensive overview on the CTD and eCTD format and content
- Gain in-depth knowledge on module 3 (CMC data)
- Options to test your knowledge and personal certificate (*)
- Intuitive learning platform
(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.
Programme
Lidia Cánovas, Michael Schaub
- EU legislation
- CTD modules 1-5
After having passed this module you understand the CTD structure and know the eCTD necessities.
Lidia Cánovas, Michael Schaub
- Regional and administrative documents (EU focus)
- Overviews and summaries
- Study report
After having passed this module you know where to include which data in the CTD dossier.
Lidia Cánovas, Michael Schaub
- Data exclusivity
- Full application
- Generic, hybrid or similar biological applications
- Well established use applications & fixed dose combinations
- Traditional use registration for herbal medicinal product
After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.
Lidia Cánovas, Michael Schaub
- Modul 4a: Introduction - CTD module 3 structure and guidelines
- Modul 4b: Drug substance - CTD module 3 drug substance data requirements
- Modul 4c: ASMP & CEP
- Modul 4d: Drug product - CTD module 3 drug product data requirements
After having passed this module you have a thorough understanding of the CMC part of the marketing authorisation dossier and know how to fill in module 3 of the CTD.
Module 1: CTD basic structure
Module 1: CTD basic structure
Lidia Cánovas, Michael Schaub
- EU legislation
- CTD modules 1-5
After having passed this module you understand the CTD structure and know the eCTD necessities.
Module 2: Organisation and content of the CTD modules
Module 2: Organisation and content of the CTD modules
Lidia Cánovas, Michael Schaub
- Regional and administrative documents (EU focus)
- Overviews and summaries
- Study report
After having passed this module you know where to include which data in the CTD dossier.
Module 3: Dossier considerations for generics and other "un-compled" application types
Module 3: Dossier considerations for generics and other "un-compled" application types
Lidia Cánovas, Michael Schaub
- Data exclusivity
- Full application
- Generic, hybrid or similar biological applications
- Well established use applications & fixed dose combinations
- Traditional use registration for herbal medicinal product
After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.
Module 4: Details on CTD module 3 content
Module 4: Details on CTD module 3 content
Lidia Cánovas, Michael Schaub
- Modul 4a: Introduction - CTD module 3 structure and guidelines
- Modul 4b: Drug substance - CTD module 3 drug substance data requirements
- Modul 4c: ASMP & CEP
- Modul 4d: Drug product - CTD module 3 drug product data requirements
After having passed this module you have a thorough understanding of the CMC part of the marketing authorisation dossier and know how to fill in module 3 of the CTD.
More options
For more information and registration simply click on this link: Regulatory Affairs Starter Pack
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
Principles
The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts share their 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 four modules and passed the multiple-choice tests, 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.
How does it work?
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.
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Further Information
List of abbreviations pharma & healthcare
Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
DEMO-Account e-Learning
Try out our e-Learning programmes free of charge and without any obligation.
Regulatory Affairs Starter Pack
Three e-Learning programmes in one bundle. Your fast track into EU Regulatory Affairs!
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de