2021-12-01 2021-12-01 , Online Online, 390,- € zzgl. MwSt. Karl-Heinz Loebel https://www.forum-institut.de/seminar/21122001-e-learning-marketing-authorisation-outside-the-ich-region/referenten/21/21_12/21122001-e-learning-marketing-authorisation-outside-the-ich-region_loebel-karl-heinz.jpg e-Learning: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed

Topics
  • Key principles: ICH, WHO, Non ICH region
  • The Marketing Authorisation Dossier: CTD, eCTD, other formats and electronic submission
  • Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...
  • Countries with or without CPP requirements
  • Regulatory submission strategy based on CPP?
Aims and objectives
This e-learning programme will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.

Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.

This e-Learning was developed in May 2018.
Who should attend

Do you need regulatory affairs expertise for submissions outside the ICH region? Then this e-learning programme is the fast track to becoming knowledgeable in this field, providing you with the fundamentals of regulatory affairs outside the EU, the US and Japan.

Basic knowledge of the principles of EU regulatory affairs is a prerequisite and can be acquired in our 'Introduction to EU Marketing Authorisation' e-learning programme.

e-Learning: Marketing Authorisation Outside the ICH Region

Marketing Authorisation
Outside the ICH Region

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 21122001

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Termin

anytime

anytime

Zeitraum

Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

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

Details

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed

Topics
  • Key principles: ICH, WHO, Non ICH region
  • The Marketing Authorisation Dossier: CTD, eCTD, other formats and electronic submission
  • Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...
  • Countries with or without CPP requirements
  • Regulatory submission strategy based on CPP?
Aims and objectives

This e-learning programme will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.

Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.

This e-Learning was developed in May 2018.

Who should attend

Do you need regulatory affairs expertise for submissions outside the ICH region? Then this e-learning programme is the fast track to becoming knowledgeable in this field, providing you with the fundamentals of regulatory affairs outside the EU, the US and Japan.

Basic knowledge of the principles of EU regulatory affairs is a prerequisite and can be acquired in our 'Introduction to EU Marketing Authorisation' e-learning programme.

Program

Module 1: Key principles
  • ICH
  • WHO
  • Non-ICH region
  • Acceptance of data
  • Registration planning
  • Registration scenarios
After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.

Module 2: The Marketing Authorisation Dossier
  • International Council for Harmonisation
  • CTD / eCTD
  • Acceptance of CTD / eCTD / electronic submission
  • Other formats
  • Dossier requirements inAustralia
    • Hong Kong
    • India
    • South Korea
    • Taiwan
    • Saudi Arabia
    • GCC
    • Jordan
    • Turkey
    • Thailand
    • China
    • South Africa
    • Russia
    • Kazakhstan
    • Eqypt Brazil
    • Mexico
    • Argentina
  • Additional requirements and summary
  • Q & A
After having passed this module you know the dossier requirements in the mentioned countries including the acceptance of an ICH (e)CTD.

Module 3: Countries with or without CPP requirements
  • What is a CPP
  • Overview of CPP dependent and non CPP dependent countries
  • Regulatory submission strategy based on CPP
After having passed this module you know which countries depend on a CPP and have hints how to develop your submission strategy.

Trailer

e-Learning: Marketing Authorisation Outside the ICH Region

Here you can get a brief insight into the e-Learning Marketing Authorisation Outside the ICH Region.

Principles

Principles

The e-learning programme 'Marketing Authorisation Outside the ICH Region' comprises three didactic modules that include videos in which the expert Karl-Heinz Loebel shares 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 a final 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.

This distinguishes our events

Modules

Hours of learning content

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Trailer

Watch the trailer for our e-Learning programme "Marketing Authorisation Outside the ICH Region".

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