| Module 3: International Marketing Authorisation Procedures
Method of examination: Course work and written or oral examination
Credit points: 7
Module Head: Dr. Ekkehard Baader
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Topics |
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| 1 |
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European Union (EU)
- European Procedures - introduction
- Legal basis and key players
- Scientific advice
- Mutual recognition procedure
- MRP / decentralized procedure
- MRP: generics
- Biosimilar products
- Centralized Procedure / Community Referrals
- New Guidelines – exceptional circumstances, conditional MA, acc. assessment
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| 2 |
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International markets, Japan, ICH, orphan drugs, compassionate use, pediatrics, penalties, small and medium-size companies |
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| 3 |
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United States of America (USA) | |
