Global stability: From regulatory framework to practical application
Including practical examples, case studies, a workshop and valuable tips & tricks
- Update Revision ICH Q1
- Challenges for biological products
- Case studies + hands-on workshop
- For self-paced training: e-Learning vailable
- Officially certified: ISO 9001 + 21001
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 2:00 pm CET - Online seminar
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 2:00 pm CET - Online seminar
You may dial in 30 minutes before the lecture starts
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.
Your speakers
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…
Your speaker
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,…
Your speaker
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.
What to Expect
- Regulatory landscape and testing requirements
- Bracketing & matrixing, storage conditions and shelf-life
- Dossier structure and post-approval changes
- Challenges for biological products
- Global stability program
- Case studies and a workshop included
Who Should Attend
This seminar is designed for professionals in the pharmaceutical and biotech industry working in stability testing, regulatory affairs, quality assurance or product development, at any level of experience.
Objective of the Event
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.
Your Benefit
After participating in the seminar, you will have
- gained a solid understanding of global stability requirements and how key frameworks such as ICH, FDA and EMA align and diverge in practice
- received an update on the revision of the ICH Q1 guideline
worked through real-world case studies on challenged shelf-life submissions and post-approval changes, and developed the confidence to handle similar situations in your own projects
- explored the specific regulatory expectations and practical considerations for biological products
built a high-level global stability strategy in a hands-on workshop, applying the theory learned to a realistic product scenario
Programme
9:00 am until 2:00 pm CET
Dr Christina Juli, Dr Beatrix Metzner
- Key regulatory frameworks (ICH, FDA, EMA and beyond)
- ICH Q1, other regulatory developments and their influence in practice
- Where do the requirements align globally and where do they diverge?
- Stability testing requirements
Dr Christina Juli, Dr Beatrix Metzner
- Advanced stability design concepts: When and how to apply bracketing and matrixing
- Factors influencing stability
- Shel-life testing and re-testing
- Case Study: "When shelf-life gets challenged"
Dr Christina Juli, Dr Beatrix Metzner
- Dossier structure: What you need to know
- Impact of changes on Stability
- How to deal with post-approval changes
- What inspectors expect
- Case Study: "A change triggers a stability crisis"
Dr Christina Juli, Dr Beatrix Metzner
- Why biological products are a category of their own: Unique challenges, specific regulatory expectations, practical tips from the field
Dr Christina Juli, Dr Beatrix Metzner
- Global challenges on stability (testing)
- Workshop: "Build your global stability strategy"
Welcome, introduction, expectations
Regulatory landscape and testing requirements
Regulatory landscape and testing requirements
Dr Christina Juli, Dr Beatrix Metzner
- Key regulatory frameworks (ICH, FDA, EMA and beyond)
- ICH Q1, other regulatory developments and their influence in practice
- Where do the requirements align globally and where do they diverge?
- Stability testing requirements
Bracketing & matrixing, storage conditions and shelf-life
Bracketing & matrixing, storage conditions and shelf-life
Dr Christina Juli, Dr Beatrix Metzner
- Advanced stability design concepts: When and how to apply bracketing and matrixing
- Factors influencing stability
- Shel-life testing and re-testing
- Case Study: "When shelf-life gets challenged"
Biobreak
Dossier structure and post-approval changes
Dossier structure and post-approval changes
Dr Christina Juli, Dr Beatrix Metzner
- Dossier structure: What you need to know
- Impact of changes on Stability
- How to deal with post-approval changes
- What inspectors expect
- Case Study: "A change triggers a stability crisis"
Challenges for biological products
Challenges for biological products
Dr Christina Juli, Dr Beatrix Metzner
- Why biological products are a category of their own: Unique challenges, specific regulatory expectations, practical tips from the field
Biobreak
Global stability program
Global stability program
Dr Christina Juli, Dr Beatrix Metzner
- Global challenges on stability (testing)
- Workshop: "Build your global stability strategy"
Recap, key takeaways, Q&As
End of seminar
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
Weitere Informationen
Qualification course: CMC-Specialist in Regulatory Affairs
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
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Technical requirements
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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Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de