; e-Learning: eCTD preparation and submission
2021-11-30 2021-11-30 , Online Online, 390,- € plus tax Karl-Heinz Loebel https://www.forum-institut.com/seminar/21122003-ectd-preparation-and-submission/referenten/21/21_12/21122003-e-learning-ectd-preparation-and-submission_loebel-karl-heinz.jpg eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

Topics
  • 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 objectives
Do 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.
Who should attend

Do you need to acquire expertise in the eCTD? Then this e-Learning is your fast track to becoming knowledgeable in this field. It will be of benefit to all those working in regulatory and medical affairs. No prior eCTD experience is required.

e-Learning: eCTD preparation and submission

e-Learning: eCTD
preparation and submission

Benefits
  • Free DEMO account
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback

Webcode 21122003

Book now

JETZT Buchen

Speaker


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

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

Topics
  • 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 objectives

Do 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.

Who should attend

Do you need to acquire expertise in the eCTD? Then this e-Learning is your fast track to becoming knowledgeable in this field. It will be of benefit to all those working in regulatory and medical affairs. No prior eCTD experience is required.

Program

Your programme Screening and editing essential marketing authorisation documents
  • 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

Efficient baseline creation
  • Step-by-step guide to baseline submissions
  • Mandatory and optional scope of baselines
  • Identifying the currently valid version of your documentation

eCTD compilation and submission
  • Best practice for eCTD compilation, submission and review
  • Typical validation issues and how to avoid them
  • Best practice: Practical short exercises

Principles & benefit

Your benefits

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.
You will receive a certificate after having completed the three webcasts and successfully passed the online multiple-choice tests.

Principles

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.

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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