CMC dossier requirements for biologics: FDA vs EU - Marketing Authorisation of large molecues in the US with a focus on CMC
CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.
- Regulatory landscape in the US
- Scientific advice
- The IND and BLA procedure
- Post-approval/maintenance: Procedures and documentation
- Quality data for marketing authorisation
- Case studies
Veranstaltungs-Code | FB24-453875-56323500 |
Bildungsziel der Schulung:
The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of large molecules/ biologics in the US.
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The course aims to:
- familiarise participants with the regulatory landscape;
- explain the differences between the US and EU MA procedures;
- provide guidance on FDA specific requirements for the compilation and maintenance of CMC documents;
- give practical approaches to typical pitfalls
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Take the opportunity to meet our experts Dr Juli and Dr Metzner and get first-hand information, suggestions and tips for daily business challenges.
Veranstaltungsort:
Online-Webinar
Vollzeit
weitere Orte/Termine
Kursart:
Online-Webinar
Kostenlos Info anfordern