Including practical examples, case studies, workshop, tips & tricks
Webcode 26112463
Dr. Christina Juli
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.
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.
26/11/2026
26/11/2026
from 9:00 am until 2:00 pm CET - Online seminar
You may dial in 30 minutes before the lecture starts
online
online
Event - 690€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€440 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
440,00 €
e-Learning: Global Stability
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€440 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
440,00 €
Event - 690€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€440 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
440,00 €
e-Learning: Global Stability
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€440 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
440,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Navigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies, hands-on workshops and peer exchange to tackle the most common stability challenges head-on.
The half-day course gives a comprehensive and practical understanding of global stability requirements for NCEs (New Chemical Entities) and NBEs (New Biological Entities) - from regulatory frameworks (including an update on the revision of the ICH Q1 guideline) to real-world application.
Through case studies, examples and hands-on modules, you will deepen your knowledge, sharpen your decision-making skills and learn how to tackle the most common stability challenges with confidence.
You will leave with concrete tools and strategies that you can apply directly in your daily work.
After participating in the seminar, you will have
Welcome, introduction, expectations
Dr Christina Juli, Dr Beatrix Metzner
Dr Christina Juli, Dr Beatrix Metzner
Biobreak
Dr Christina Juli, Dr Beatrix Metzner
Dr Christina Juli, Dr Beatrix Metzner
Dr Christina Juli, Dr Beatrix Metzner
End of seminar
This webcast series can be taken as an elective module as part of our CMC Specialist in Regulatory Affairs certification program.
The program structure:
You will attend our introductory course, "The CMC Manager in Regulatory Affairs"
Afterward, you will participate in 3 additional seminar modules (= 3 seminar days), which you can customize from the course curriculum
You will receive structured professional development and comprehensive knowledge in CMC Regulatory Affairs
You can specialize by selecting seminars tailored to your specific area of focus
Please visit our website
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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