Global CMC requirements: focus on Asia, Japan, and Eastern Europe

Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY

Head of CMC, CCM RA Office NBE
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 ratiopharm GmbH in Ulm, Germany and started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance.
From 2018 to 2025, she was working at the manufacturing site for biopharmaceuticals in Biberach, Germany as Head of CMC Management CMB where she focused on the CMC development for biologics for the contract manufacturing business of Boehringer Ingelheim.
In her current role as Head of CMC RA Office NBE, she focuses on the CMC development for biologics and is responsible for CMC regulatory topics of development projects, products, and strategic regulatory projects.
Beyond that she is an active participant of several industry groups such as the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups) or EFPIA.

Independent Regulatory Consultant, RUSSIA

Galina Senchukova is an expert on registration of Drug Products in Russia, EAEU and CIS non-EAEU countries. Before becoming an independent regulatory consultant, in 2017-2024 she worked as Regulatory and Quality Assurance Head at CSL Behring and in 2013-2017 - as Regulatory Head at Sanofi Pasteur in Russia. Before that she worked on different regulatory positions at Sanofi, MSD and GSK.
PhD in Pharmaceutical Chemistry, advanced RA professional with about 18 years hands-on experience in Rx, biological and biotechnological products registration (blood plasma products and vaccines), mostly specializing in CMC area. Together with her local team achieved many successful registration of Drug Products in complicated and challenging regulatory environment.

AstraZeneca Pharma India Pvt. Ltd.,
Begaluru, INDIA

He 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.