- Online training -
Webcode 25102451
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 Wuerzburg, 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 in the Tech RA department at 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 (Post Approval Strategy and Regulatory Governance working groups).
Dr. Beatrix Metzner
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss
Global Head of CMC Management Biopharma Dr. Beatrix Metzner studied chemistry at the University of Regensburg and Freiburg, Germany, specializing in biochemistry. Her professional career began at MediGene AG. In 2005, she joined Merck KGaA, where she worked as Director Global Regulatory Oncology until November 2013. At Boehringer Ingelheim, she held various management positions. Since January 2023 she acts as Global Head of CMC Management Biopharma. Dr Beatrix Metzner is a highly accomplished professional with more than 20 years experience in the CMC regulatory field of new biological entities (NBEs) and biosimilars.
Dr. Elke Jahr
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY
Team Lead for CMC Expert Operations Dr. Elke Jahr studied Pharmacy at the University of Greifswald, Germany. After completing her practical training in a pharmacy and at Jenapharm GmbH, she proceeded to the University of Marburg, Germany for her PhD in Pharmaceutical Technology and Biopharmacy. Her professional career began in 2006 as the Head of Laboratory, Analytical Development at Sanofi-Aventis, Frankfurt. In 2009, she joined Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany as a CMC Regulatory Affairs Manager, where she was responsible for both development projects and life cycle products. Since 2017, Elke has been working in CMC Management, initially as a CMC Expert and currently as the Team Lead for CMC Expert Operations. Dr. Elke Jahr has in-depth knowledge and many years of experience in the CMC regulatory field of new chemical entities (NCEs).
07/10/2025
07/10/2025
09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,290 € 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 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).
The 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:
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 & 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
End of the online training course
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