e-Learning: Marketing Authorisation Outside the ICH Region
Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...
- 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?
This distinguishes our event
Aims and objectivesThis 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.
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.
- Non-ICH region
- Acceptance of data
- Registration planning
- Registration scenarios
- International Council for Harmonisation
- CTD / eCTD
- Acceptance of CTD / eCTD / electronic submission
- Other formats
- Dossier requirements inAustralia
- Hong Kong
- South Korea
- Saudi Arabia
- South Africa
- Eqypt Brazil
- Additional requirements and summary
- Q & A
- What is a CPP
- Overview of CPP dependent and non CPP dependent countries
- Regulatory submission strategy based on CPP
Director, Principle Consultant Regulatory Operations
Nähere Informationen finden Sie hier.
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.
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.