Kurs derzeit nicht verfügbar
e-Learning: Marketing Authorisation Outside the ICH Region - Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...
Seminar
Online
Beschreibung
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Kursart
Seminar
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Methodik
Online
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Dauer
1 Tag
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.
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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.
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This e-Learning was developed in May 2018.
Hinweise zu diesem Kurs
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.
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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.
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Themen
- Marketing
- E-learning
Inhalte
e-Learning: Marketing Authorisation Outside the ICH Region - Specialties in Asia, ASEAN, Middle East, LATAM, EAEU, Turkey...