CMC dossier requirements for biologics: FDA vs EU - Marketing Authorisation of large molecues in the US with a focus on CMC - Webinar von FORUM Institut für Management GmbH

- Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and documentation - Quality data for marketing authorisation - Case studiesCMC 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.

The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of large molecules/ biologics in the US.- 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- Take the opportunity to meet our experts Dr Juli and Dr Metzner and get first-hand information, suggestions and tips for daily business challenges.

This course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for large molecules/biologics and wish to develop their knowledge of the US regulatory environment.The specific focus is on requirements for quality data.- Both beginners and professionals that are involved in the compilation and maintenance of the CMC documentation for large molecules will benefit from this course.