e-Learning: CTD Module 3
Data requirements in the EU
- Up-to-date expert knowledge
- Flexibility in location and timing
- You establish your own learning speed
- Tests and feedback
- Officially certified according to ISO 9001 and ISO 21001
e-Learning
Ab
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (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
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (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.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
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…
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.
What to Expect
- CTD structure and applicable guidelines
- Drug substance Part
- ASMF and CEP
- Drug product part
Who Should Attend
This e-Learning program addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good knowledge of the structure and content of CTD Module 3.
Objective of the Event
Module 3 is an essential part of the CTD. It presents data on the quality of the drug substance and drug product. But what data is required? How should Module 3 be structured? These are the topics of our e-learning program.
In this e-Learning you will:
- learn that Module 3 is divided into drug substance and drug product parts
- take a detailed look at the individual subchapters, their meaning and special requirements
- get to know what data is essential for the respective subchapters and why
- and learn the roles of the ASMF and CEP, and how to integrate them into Module 3.
This e-learning was newly created and updated in August 2025.
Your Benefit
The e-learning format allows you to create your own schedule, pause and rewind the video at any time, and avoid being pressed for time.
You will benefit from the long-term experience of the expert Lidia Cánovas and gain a good overview on the important aspects that concern the structure and content of CTD Module 3.
Programme
Lidia Cánovas
- CTD Module 3 structure
- Applicable guidelines
After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.
Lidia Cánovas
- CTD Module 3 drug substance data requirements
After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.
Lidia Cánovas
- Application and use
- Structure
- Procedure
After having passed this module you know the roles of the ASMF and CEP and when they are used.
Lidia Cánovas
- CTD Module 3 drug product data requirements
After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements.
(The information that should be included in the appendices and the regional information follow in the short module 5.)
Module 1: Introduction
Module 1: Introduction
Lidia Cánovas
- CTD Module 3 structure
- Applicable guidelines
After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.
Module 2: Drug substance part
Module 2: Drug substance part
Lidia Cánovas
- CTD Module 3 drug substance data requirements
After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.
Module 3: ASMF and CEP
Module 3: ASMF and CEP
Lidia Cánovas
- Application and use
- Structure
- Procedure
After having passed this module you know the roles of the ASMF and CEP and when they are used.
Module 4: Drug product part
Module 4: Drug product part
Lidia Cánovas
- CTD Module 3 drug product data requirements
After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements.
(The information that should be included in the appendices and the regional information follow in the short module 5.)
Trailer
Downloads
Request the documents using our form.
Brochure
Abbreviation list RA/CMC
Weitere Informationen
Principles
The 'CTD Module 3' e-learning program comprises four modules that include - amongst others - videos in which the expert Lidia Cánovas shares her expertise with you.
You can also download and print the corresponding presentation documents.
Each module also includes complementary details (links, guideline texts, etc.).
The e-learning ends with an online test, which helps you practise and apply your newly gained knowledge.
Once you have completed the four modules and passed the test, you will be awarded a certificate, which you can print out directly.
The e-learning program should be completed within three months.
How does it work?
1. Register for an e-learning program on our website.
2. You will receive an email with your login data for access to our learning platform.
3. Log in to start your e-learning program.
4. Complete the modules at your own pace.
5. Complete a multiple-choice test.
6. Once you have passed the test, you will be awarded a certificate, which you can then print out.
Try out the demo versions of our e-learning programs to get an idea of our learning environment.
For more information, please visit our Website
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Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de