Dr. Christina Juli
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Head of CMC Management CMB Dr Christina Juli studied pharmacy at the University of Würzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined the ratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working at the manufacturing site for biopharmaceuticals of Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of CMC Management CMB, she focuses on the CMC development for biologics and is responsible for the definition compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group.
Dr. Beatrix Metzner
Boehringer Ingelheim Biopharmaceuticals GmbH, Biberach an der Riss
Head of CMC Management Biopharma More than 15 years' experience in filing pre and post-approval worldwide, with a specific focus on biologics (NBE and biosimilar)
23/10/2024
23/10/2024
09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
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.
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:
After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics. Hands-on tipps and tricks and the interactive case study session will enable you to link the theoretical knowledge with the individual challenges of putting it into practice.
Welcome, introduction, expectations
Coffee break
Lunch break
Coffee break
Summary and outstanding questions
End of the online training course
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