CMC Writing

Head of Scientific CMC Documentation Drug Substance & Customer Services Until October 2021, Anne Katrin Bräckow initially held various quality functions in CMC (including as CMC Expert Operations) and Change Control Management at Boehringer Ingelheim Pharma GmbH & Co. KG. Since October 2021, she has been leading the divisional CMC Writing Team, which deals with document creation for NCEs' API dossiers.

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).

Head of Scientific CMC Documentation DP Nora is a biologist. Her professional career started by a consultancy in Germany in 2004. From 2007 to 2010 she worked at Abbott as a manager in quality assurance. From 2010 to 2011she worked as a manager at Wilmar Schwabe in CMC and regulatory department. After this period she joined again Abbott from 2011 to 2017 again in quality assurance. From 2017 to 2023 she worked as a senior manager in CMC regulatory at Pharmalex. Nora joined Boehringer Ingelheim in 2024 and has been working in the CMC Management Department as head of scientific CMC documentation DP. She and her team are responsible for the content of CMC documents (Module 3) of the regulatory submission documentation for Drug Product. The CMC documentation is harmonized across products and sites and complies with the latest scientific and regulatory findings.