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FORUM · Institut für Management GmbH
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69115 Heidelberg
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e-Learning: Marketing Authorisation Outside the ICH Region
Marketing Authorisation
Outside the ICH Region
e-Learning
2018-12-17 2018-12-17 an Ihrem Arbeitsplatz Online

e-Learning: Marketing Authorisation Outside the ICH Region

Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...

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?

This distinguishes our event

3
Modules
2
Hours of learning content
3
Controls of success
24
Hour access to your personal learning environment on every day

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.
Your speaker
Karl-Heinz Loebel
PharmaLex GmbH, Mannheim


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