CMC requirements in
Asia, Japan and Eastern Europe

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 Product Market Authorization and Quality Assurance, PhD in Pharmaceutical Chemistry. 20 years in regulatory area in total: for 6 years - Tutor of Pharmaceutical Chemistry at Pharmaceutical State University (Pyatigorsk, Russia), 9 years of experience in Drug Product development for Russian manufacturers and 6 years - in local batch release quality control; 11 years in Big Pharma RA departments.

Prashant Shroff has worked at CDSCO (Zonal office of Indian Govt. Authority) as a Technical Data Associate. He started his professional journey in the private sector with Sun Pharmaceutical Ind. Ltd. in 2016 and then he joined Pharmalex India Pvt. Ltd. Currently, he is working as Regulatory Affairs Manager at AstraZeneca Pharma India Pvt. Ltd. In his career, he has well-versed experience for the Indian registration procedures for drug products as well biologicals covering regulatory strategy throughout the life cycle management, documentation, pharmacopoeial compliance, labelling, package inserts etc.