2024-12-30 2024-12-30 , online online, 390 € zzgl. MwSt. Lidia Cánovas https://forum-institut.de/seminar/25122497-e-learning-ctd-module-3/referenten/25/25_12/25122497-e-learning-ctd-module-3_cnovas-lidia.jpg e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

Topics
  • CTD structure and applicable guidelines
  • Drug substance Part
  • ASMF and CEP
  • Drug product part


Who should attend
This e-Learning programme 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.
Aims and objectives
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 programme.
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 updated in August 2022.
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. Feel free to pose questions while completing each single or after having completed all four videos.

e-Learning: CTD Module 3

e-Learning:
CTD Module 3

- e-Learning -

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback

Webcode 25122497

Jetzt buchen

JETZT Buchen
Referent

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.

Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 390 € 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. Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.


SPECIAL OFFERS
APIs in Regulatory Affairs
19. - 20.02.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.640,00 €
GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten
06.02.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Prozessvalidierung - Anforderungen an CMC-Daten
26.08.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Key Topics der CMC-Dokumentation: Vom GMP- zum RA-Dokument
10.07.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Pharmazeutische Entwicklung
03.06.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Der CMC-Manager in Regulatory Affairs
29. - 30.04.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €
CMC für Biologicals
05.05.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Pharmazeutische Wirkstoffe: Von der Syntheseentwicklung zum CMC Dossier
08.05.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
CMC Management in Regulatory Affairs
22-23/05/2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €

Veranstaltung - 390 € 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. Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.

SPECIAL OFFERS
APIs in Regulatory Affairs
19. - 20.02.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.640,00 €
GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten
06.02.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Prozessvalidierung - Anforderungen an CMC-Daten
26.08.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Key Topics der CMC-Dokumentation: Vom GMP- zum RA-Dokument
10.07.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Pharmazeutische Entwicklung
03.06.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Der CMC-Manager in Regulatory Affairs
29. - 30.04.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €
CMC für Biologicals
05.05.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
Pharmazeutische Wirkstoffe: Von der Syntheseentwicklung zum CMC Dossier
08.05.2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.240,00 €
CMC Management in Regulatory Affairs
22-23/05/2025, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
1.940,00 €

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

Topics

  • CTD structure and applicable guidelines
  • Drug substance Part
  • ASMF and CEP
  • Drug product part


Who should attend
This e-Learning programme 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.

Aims and objectives

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 programme.
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 updated in August 2022.

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. Feel free to pose questions while completing each single or after having completed all four videos.

Programm

Module 1: Introduction (approx. 10 minutes)
  • 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 (approx. 30 minutes)
  • 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 (approx. 20 minutes)
  • 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 (approx. 45 minutes)
  • CTD Module 3 drug product data requirements
  • Appendices and regional information
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.

Trailer

e-Learning: CTD Module 3

Here you can get a brief insight into the e-Learning CTD Module 3.



Our Partner

ASPHALION

Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.



Principles

Principles

The 'CTD Module 3' e-learning programme comprises four didactic modules that include videos in which expert Lidia Cánovas shares her expertise with you (videos with a time duration between 10 minutes and 45 minutes; for more details see the timetable). You can also download and print the corresponding presentation documents. Each module also includes additional documents (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 programme should be completed within three months.

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 access to our learning platform. 3. Log in to start your e-learning programme. 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 programmes to get an idea of our learning environment.

This distinguishes our events

Modules

Hours of learning content

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Trailer

Watch the trailer for our e-Learning programme "CTD Module 3".

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