; e-Learning: Common Technical Document & eCTD
2021-11-30 2021-11-30 , Online Online, 590,- € plus tax Lidia Cánovas https://www.forum-institut.com/seminar/21122000-e-learning-common-technical-document-ectd/referenten/21/21_12/21122000-e-learning-common-technical-document-ectd_cnovas-lidia.jpg e-Learning: Common Technical Document & eCTD

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.

Topics
  • 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
Aims and objectives
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 developed in July 2018.
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.

e-Learning: Common Technical Document & eCTD

Common Technical
Document & eCTD

e-Learning

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback
  • Certificate of completion
  • Compatibility with mobile devices

Webcode 21122000

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

anytime

anytime

Period

Venue

Online

Online

Fee
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

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.

Topics
  • 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
Aims and objectives

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 developed in July 2018.

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.

Program

Lidia Cánovas, Michael Schaub

Module 1: CTD basic structure
  • 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

Module 2: Organisation and content of the CTD Modules
  • 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

Module 3: Dossier considerations for generics and other "un-compled" application types
  • 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

Module 4: Details on CTD Module 3 content
  • Modul 4a: IntroductionCTD 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.

Trailer

e-Learning: Common Technical Document & eCTD

Here you can get a brief insight into the e-Learning Common Technical Document & eCTD.

Principles

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.

This distinguishes our events

Modules

Hours of learning content

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