Variations in Europe
Practical Guidance on Classification, Submission and Current Regulatory Updates
- Update on new Variation Regulation & Guideline
- Practical examples and case studies
- Optional e-Learning bookable
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day I: 09:00 am - 16:45 pm CET
Day II: 09:00 am - 17:00 pm CET
Buchungsdetails
Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day I: 09:00 am - 16:45 pm CET
Day II: 09:00 am - 17:00 pm CET
Variation regulation, new classification guideline, eSubmission and variation management: All processes explained in this online course.
Your speakers
Carmen Bas Jiménez
Asphalion, S.L., SPAIN
Senior Regulatory Affairs Officer
I am pharmacist working as a Senior Regulatory Affairs Officer at Asphalion, within the Life Cycle Management team. I have almost five years of…
Your speaker
Carmen Bas Jiménez
Asphalion, S.L., SPAIN
Senior Regulatory Affairs Officer
I am pharmacist working as a Senior Regulatory Affairs Officer at Asphalion, within the Life Cycle Management team. I have almost five years of experience in the Pharmaceutical Industry.
My experience is based on the compilation, update, and review of dossiers at EU and International levels, specializing in other regions such as Latin America, Asia Pacific, and Middle East, as well as submission management in US and CA.
Also, I previously worked as a Regulatory Affairs Associate at the company Chemo, which is one of the different business areas that belongs to the Insud Pharma Group.
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company,
THE NETHERLANDS
Regulatory Consultant
Your speaker
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company,
THE NETHERLANDS
Regulatory Consultant
Dr. Regina Heckenberger
Bayer AG, GERMANY
Head of Regulatory CMC Strategy II;
Regina is a biologist by training holding a PhD in Natural Sciences and has over 20 years' experience in regulatory affairs.
She and her team is…
Your speaker
Dr. Regina Heckenberger
Bayer AG, GERMANY
Head of Regulatory CMC Strategy II;
Regina is a biologist by training holding a PhD in Natural Sciences and has over 20 years' experience in regulatory affairs.
She and her team is specialized on regulatory CMC topics and works on life-cycle management for small and large molecules, on NDAs/MAAs as well as on development projects and respective quality support for CTA/INDs.
Dr. Elke Löber
Boehringer Ingelheim International GmbH
Dr. Elke Löber is Senior CMC Regulatory Affairs Manager at Boehringer Ingelheim International GmbH, where in the last 14 years she was responsible for worldwide…
Your speaker
Dr. Elke Löber
Boehringer Ingelheim International GmbH
Dr. Elke Löber is Senior CMC Regulatory Affairs Manager at Boehringer Ingelheim International GmbH, where in the last 14 years she was responsible for worldwide submissions and post approval life cycle management of new chemical entities. Between 2001 and 2011 she held positions within Boehringer Ingelheim Pharma GmbH and Co. KG within Quality Management as head of laboratory for in-process control testing as well as drug substance project manager for new chemical entity drug substance development. She holds a PhD in Chemistry from the University of Kaiserslautern and worked as postdoctoral associate at the Yale University, USA.
What to Expect
- Variation Regulation & new Guideline
- Classification and submission (including new features since 15.01.26)
- Type IA Notification, Type IB and Type II Variations
- Grouping and worksharing
- Variation submission (eAF, CESP)
- Quality-related variations: Changes in the production process, analytics, formulation and packaging
Who Should Attend
This practical seminar is aimed at professionals who are new to variation management or who need a comprehensive update on the new variation framework, and who are involved in planning, preparing, or submitting variations. Basic knowledge of the EU Marketing Authorisation framework is required.
Employees in the following departments will particularly benefit from the seminar:
- regulatory affairs
- quality assurance
- production
Objective of the Event
This training will bring you the latest information in the planning, classification and submission of variations. All relevant changes related to the new Variation Regulation (applicable since 01.01.25) and Guideline (applicable since 15.01.26) will be discussed.
Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation e-application form and organisation of grouping and worksharing.
Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the new classification guideline and the Q&A paper will reinforce your knowledge.
Your Benefit
In this seminar you will gain hands-on knowledge on
- the basics of the variation system (inlcuding all updates introduced by the new Regulation & Guideline).
- the correct classification of variations.
- the usage and the advantages of grouping and worksharing.
- how to submit variations smoothly.
Programme
Day 1: 09:00 - 17:00 seminar
Day 2: 09:00 - 17:00 seminar
Day 1
09:00
09:15
Carmen Bas Jiménez
- Variation Regulation (basic principles & the new regulation (EU) 2024/1701)
- Updated variation guideline
- Changes according to the variation regulation vs purely national changes
- PACMP
10:00
Carmen Bas Jiménez
- Type IA-changes according to the classification guideline
- Annual update
- Immediate notification (Type IAIN)
10:30
10:45
Ingrid Prieschl
- Type IB-changes according to the classification guideline
- Timelines and processing
- Type IB by default
11:15
Carmen Bas Jiménez
- Processing of type II variations
- Timelines, submission and validation
12:00
13:00
Ingrid Prieschl
- Grouping of type IA notifications
- Grouping of extensions
- Grouping of different types of variations
- (Super-)grouping IA variations and worksharing according to new variation framework
- Practical examples
- Efficient variation management
14:00
14:15
Carmen Bas Jiménez
- Variation e-application form
- SPOR; Web-based e-AF; PLM Portals (CESP submission, EMA Gateway, IRIS)
15:30
15:45
Carmen Bas Jiménez
- Safety related changes and urgent safety restrictions
- Line Extensions
16:15
16:45
Welcome and introduction
09:15
Basics, fundamentals & classification
Basics, fundamentals & classification
Carmen Bas Jiménez
- Variation Regulation (basic principles & the new regulation (EU) 2024/1701)
- Updated variation guideline
- Changes according to the variation regulation vs purely national changes
- PACMP
10:00
Type IA-notification
Type IA-notification
Carmen Bas Jiménez
- Type IA-changes according to the classification guideline
- Annual update
- Immediate notification (Type IAIN)
Coffee break
10:45
Type IB-variations
Type IB-variations
Ingrid Prieschl
- Type IB-changes according to the classification guideline
- Timelines and processing
- Type IB by default
11:15
Type II-variations
Type II-variations
Carmen Bas Jiménez
- Processing of type II variations
- Timelines, submission and validation
Lunch break
13:00
Grouping, super-grouping and worksharing
Grouping, super-grouping and worksharing
Ingrid Prieschl
- Grouping of type IA notifications
- Grouping of extensions
- Grouping of different types of variations
- (Super-)grouping IA variations and worksharing according to new variation framework
- Practical examples
- Efficient variation management
Short break
14:15
Variation submission
Variation submission
Carmen Bas Jiménez
- Variation e-application form
- SPOR; Web-based e-AF; PLM Portals (CESP submission, EMA Gateway, IRIS)
Coffee break
15:45
Special notification of change
Special notification of change
Carmen Bas Jiménez
- Safety related changes and urgent safety restrictions
- Line Extensions
Q&As and outstanding questions
End of seminar day I
Day 2
09:00
Elke Löber
- Notification or variation
- Batch size change
- Change in the manufacturing flow
- Site transfer
10:30
10:45
Dr. Regina Heckenberger
- API and excipient new suppliers
- How to assess a change and build a submission plan
- Challenges
12:15
13:15
Elke Löber
- Contract laboratories
- Analytical methods
- Acceptance criteria/specifications
- Regulatory change control management
14:30
14:45
Dr. Regina Heckenberger
- Primary/secondary packaging (specification, testing)
- Change of packaging sites
- Labelling impact
16:00
All speakers
16:45
17:00
09:00
Changes in the production process
Changes in the production process
Elke Löber
- Notification or variation
- Batch size change
- Change in the manufacturing flow
- Site transfer
Coffee break
10:45
Changes in the formulation
Changes in the formulation
Dr. Regina Heckenberger
- API and excipient new suppliers
- How to assess a change and build a submission plan
- Challenges
Lunch break
13:15
Changes in the analytics - changes of:
Changes in the analytics - changes of:
Elke Löber
- Contract laboratories
- Analytical methods
- Acceptance criteria/specifications
- Regulatory change control management
Coffee break
14:45
Packaging and production changes
Packaging and production changes
Dr. Regina Heckenberger
- Primary/secondary packaging (specification, testing)
- Change of packaging sites
- Labelling impact
Practical examples and case studies
Q&As and outstanding questions
End of online seminar
More Options
Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.
Simply register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€390 + local VAT rather than €490 + local VAT).
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.
Brochure
Further Informations
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.
Access to and procedure for online events
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.
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Further Information
Qualification Course Regulatory Affairs Manager
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
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Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de