Global variations and lifecycle management
Strategies for Effective Global Lifecycle Management Across Key Regulatory Regions
- First-hand information
- Submit your questions prior to the training
- 4 webcasts à 2h: Easily fit into your work routine
- Officially certified according to ISO 9001 and ISO 21001
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate of attendance, access to the Learning Space, comprehensive technical support, a pre-meeting session, and recordings of the webcasts.
Period:
Live Webcasts
:
25 February 2027: 10:00 - 12:00
4 March 2027: 10:00 - 12:00
11 March 2027: 10:00 - 12:00
18 March 2027: 10:00 - 12:00
Q&A session follows each live webcast. Recordings will be available afterwards.
You may dial in 20 minutes before the training begins.
Details:
Buchungsdetails
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate of attendance, access to the Learning Space, comprehensive technical support, a pre-meeting session, and recordings of the webcasts.
Period:
Live Webcasts
:
25 February 2027: 10:00 - 12:00
4 March 2027: 10:00 - 12:00
11 March 2027: 10:00 - 12:00
18 March 2027: 10:00 - 12:00
Q&A session follows each live webcast. Recordings will be available afterwards.
You may dial in 20 minutes before the training begins.
Details:
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!
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.
Carmen Bas Jiménez
Asphalion, S.L., Barcelona, SPAIN
Regulatory Affairs Associate Manager
Carmen Bas Jiménez is a pharmacist and works as Regulatory Affairs Associate Manager at Asphalion, where she is part of the Life…
Your speaker
Carmen Bas Jiménez
Asphalion, S.L., Barcelona, SPAIN
Regulatory Affairs Associate Manager
Carmen Bas Jiménez is a pharmacist and works as Regulatory Affairs Associate Manager at Asphalion, where she is part of the Life Cycle Management team. She has several years of experience in the pharmaceutical industry. Her work focuses on the compilation, update and review of dossiers at EU and international level, with particular expertise in Latin America, Asia Pacific and the Middle East, as well as submission management for the United States and Canada. Previously, she worked as Regulatory Affairs Associate at Chemo, a business area of the Insud Pharma Group.
Maria Roncero Lendinez
Asphalion, S.L., Barcelona, SPAIN
Regulatory Affairs Consultant
María Roncero Lendínez studied Pharmacy from the Universidad Complutense de Madrid and has over nine years of experience in the…
Your speaker
Maria Roncero Lendinez
Asphalion, S.L., Barcelona, SPAIN
Regulatory Affairs Consultant
María Roncero Lendínez studied Pharmacy from the Universidad Complutense de Madrid and has over nine years of experience in the pharmaceutical sector. She joined Asphalion S.L. in 2022. She has focused on the life-cycle management of medicinal products, ensuring regulatory compliance and coordinating submission processes across Europe, the Asia-Pacific region, and the Middle East. Her close collaboration with local stakeholders has enabled her to develop a comprehensive perspective of regulatory requirements in these areas.
What to Expect
- Strategic Planning for Variation Submissions
- Lifecycle Management Challenges
- Global CMC Strategy & Regulatory Overview
- Collaborating with Affiliates/Local Partners
- Key Submission Formats & Requirements Globally
Who Should Attend
This webcast series is designed for professionals involved in global lifecycle management. It is especially beneficial for employees in Regulatory Affairs, CMC, and Quality Assurance.
Please note that a basic understanding of the EU variations system is required for this seminar.
Objective of the Event
This webcast series, delivered in four sessions of two hours each, provides an in-depth understanding of the complexities in global lifecycle management.
Our highly experienced speakers will explain how to plan and implement variations on a global scale and collaborate effectively with local partners on ongoing lifecycle responsibilities. The focus is on key regions: the USA, Asia (China, Japan, South Korea), LATAM (Central America and Brazil), and the Gulf Cooperation Council (GCC).
Practical examples will cover both small and large molecule product classes.
By the end of this webcast series, you will be equipped to manage global lifecycle processes efficiently.
Your Benefit
- Meet our industry and consultancy experts, ready to share their in-depth knowledge with you!
- Gain practical lifecycle management expertise for essential markets!
- Easily integrate the webcast sessions into your daily work routine!
- Missed a live session? No worries! Benefit from the recording, available after each webcast!
Your programme
Dates: 25 February / 4 March / 11 March and 18 March 2027;
Time: 10:00 am to 12:00 pm (CET)
25/02/2027, 10:00 - 12:00
- EU vs. US variation: Type IA, IB and Type II compared to Annual report, CBE-30 and PAS (including examples)
- Lifecycle management: Strategic planning of variation submission
- Challenges during lifecycle management
04/03/2027, 10:00 - 12:00
- Global CMC strategy
- Lifecycle management in Asian countries
- Working with affiliates/local partners
11/03/2027, 10:00 - 12:00
- Regulatory framework
- Lifecycle management and working with affiliates/local partners
- Submission format
18/03/2027, 10:00 - 12:00
- Regulatory framework
- Lifecycle management and working with affiliates/local partners
- Submission format
25/02/2027, 10:00 - 12:00
25/02/2027:
EU variations vs US variations
25/02/2027: EU variations vs US variations
- EU vs. US variation: Type IA, IB and Type II compared to Annual report, CBE-30 and PAS (including examples)
- Lifecycle management: Strategic planning of variation submission
- Challenges during lifecycle management
04/03/2027, 10:00 - 12:00
04/03/2027: Asian variations with a focus on China, Japan and South Korea
04/03/2027: Asian variations with a focus on China, Japan and South Korea
- Global CMC strategy
- Lifecycle management in Asian countries
- Working with affiliates/local partners
11/03/2027, 10:00 - 12:00
11/03/2027: LATAM variations
11/03/2027: LATAM variations
- Regulatory framework
- Lifecycle management and working with affiliates/local partners
- Submission format
18/03/2027, 10:00 - 12:00
18/03/2027: Gulf Cooperation Council (GCC) variations
18/03/2027: Gulf Cooperation Council (GCC) variations
- Regulatory framework
- Lifecycle management and working with affiliates/local partners
- Submission format
More Options
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Downloads
Request the documents using our form.
List of Abbreviations: Regulatory Affairs and CMC
More information
Send us your individual questions
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to v.planitz@forum-institut.de.
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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 ‘Details’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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.
This is what distinguishes this event
The content and practical benefits received a rating of 4 out of 5 stars (September 2026)
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Further Information
e-Learning - Click and learn
We provide flexible education and training with high-quality e-Learning programmes for several topics.
Our rating in 2025
More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de