CMC dossier requirements: FDA vs EU - Overview on regulatory procedures for chemicals & biologicals (US)

- Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and documentation - Requirements for the handling of quality data - Hot topics and current challengesCMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).LernzieleThe purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of small and large molecules (chemicals & 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, Dr Metzner and Dr Jahr and get first-hand information, suggestions and tips for daily business challenges.ZielgruppenThis course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for small and large molecules (chemicals & 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 small and large molecules will benefit from this course.