- Online Training -
Webcode 25032451
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 Galina Senchukova
CSL Behring Biotherapies, Moscow, RUSSIA
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
AstraZeneca Pharma India Pvt. Ltd.
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.
04-25/03/2025
04-25/03/2025
04 March, 06 March, 11 March, 25 March 2025
Live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,350 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,350 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Konferenzmanagerin Healthcare
+49 6221 500-652
b.wessels@forum-institut.de
Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
During this webcast series you will learn about the specific CMC requirements in China, India, Japan/South Korea and Russia/EAEU.
Four (local) experts will share valuable information regarding
Dr. Christina Juli
Dr. Christina Juli
Dr. Christina Juli
End of webcast
Welcome and introduction
Dr. Christina Juli
Dr. Christina Juli
End of webcast
Welcome and introduction
Dr Galina Senchukova
Dr Galina Senchukova
End of webcast series
Welcome and introduction
Prashant Shroff
Prashant Shroff
End of webcast
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