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戻る Agenda
Session 6: Legal Types of Marketing Authorizations in the EU
Session Chair(s)
Diptee A. Gajjar, PhD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
- Full dossier
- Generics, abbreviated drug application
- Biosimilars
- Bibliographic application, well established use
- Combination products
- Regulatory data protection and exclusivity
- Data protection
- Market exclusivity
- Extension of supplementary protection certificate