e-Learning: EU Variation System and Procedures
Classification, Grouping, Worksharing & Submission
- Up-to-date expert knowledge
- Flexibility in location and timing
- Compatibility with mobile devices
- Tests & certificate of completion (*)
- Officially certified to ISO 9001 and ISO 21001
e-Learning
Ab
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €490 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Buchungsdetails
e-Learning
Ab
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €490 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
Your speaker
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, Oss, THE NETHERLANDS
Regulatory Consultant
Your speaker
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, Oss, THE NETHERLANDS
Regulatory Consultant
What to Expect
- Module 1: Overview of the EU law and Guidelines - including Commission Delegated Regulation (EU) 2024/1701
- Module 2: Classification of Variations
- Module 3: Procedural Aspects of Variations
- Module 4: Grouping and Worksharing
- Module 5: Application Form et cetera
- Bonus material - Module 5a: Live recording of a webcast on the electronic submission of variations (German language with English subtitles)
- Module 6: Other Post-Authorisation Procedures
Who Should Attend
This e-learning course is intended as an introduction to EU variations for anyone who needs to understand, classify or submit variations to the relevant agency, particularly those working in regulatory affairs. No prior experience with variations is required.
Objective of the Event
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.
Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.
This e-Learning was updated June 2025. It covers all relevant updates introduced by Commission Delegated Regulation (EU) 2024/1701.
NEW: bonus material - live recording of a webcast on the electronic submission of variations from December 2024 (German language with English subtitles).
Your Benefit
- Expert knowledge & flexibility in location and timing
- Get an overview of the EU law and guidelines - inlcuding Commission Delegated Regulation (EU) 2024/1701
- All you need to know on variation procedures
- Options to test your knowledge and personal certificate (*)
- All on an intuitive learning platform
(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.
Programme
Content:
- European Union law covering marketing authorisation procedures
- Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents
Learning objectives: After having passed this module you can
- understand the principles of the European law covering Marketing Authorisation procedures including variations
- you know which guidance documents are applicable for variations and where you can find
Content:
- Category of variations and decision tree
- Recommendation on unforeseen variations (Article 5)
- Types of variations: Type IA / IAIN; Type IB; Type II
- Extensions of marketing authorisations
- Pre-submission query service
Learning objectives: After having passed this module
- you will be able to differentiate between the types of variations
- understand what recommendations according to Article 5 are
- gain insight into the documentation requirements of the applications
- you know what an extension application entails
Conten:
- Centralised and mutual recognition variation procedure: Type IA / IAIN; Type IB; Type II
- Variation milestone dates
- Urgent safety restrictions
Learning objectives: After having passed this module
- you understand the procedural aspects of the variation and with regards to timelines
- you know when to implement the change
- gain insight into the milestone dates for the variations
- understand what an Urgent Safety Restriction is
- Legal context and definitions
- Grouping
- Worksharing
- Electronic application form; data on medicines - SPOR
- Cover letter
- eCTD requirements
- Editorial changes
recording of the webcast "Elektronische Einreichung von Variations"
- current PLM and eAF creation experiences
- Article 61(3) notifications
- Marketing authorisation validity
- Marketing status report and marketing cessation
- Renewal; Post-Authorisation Measures (PAMs)
- Repeat-Use procedure; marketing authorisation transfer; change of RMS
- Referral procedures
Module 1: Overview of the EU law and Guidelines
Module 1: Overview of the EU law and Guidelines
Content:
- European Union law covering marketing authorisation procedures
- Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents
Learning objectives: After having passed this module you can
- understand the principles of the European law covering Marketing Authorisation procedures including variations
- you know which guidance documents are applicable for variations and where you can find
Module 2: Classification of Variations
Module 2: Classification of Variations
Content:
- Category of variations and decision tree
- Recommendation on unforeseen variations (Article 5)
- Types of variations: Type IA / IAIN; Type IB; Type II
- Extensions of marketing authorisations
- Pre-submission query service
Learning objectives: After having passed this module
- you will be able to differentiate between the types of variations
- understand what recommendations according to Article 5 are
- gain insight into the documentation requirements of the applications
- you know what an extension application entails
Module 3: Procedural Aspects of Variations
Module 3: Procedural Aspects of Variations
Conten:
- Centralised and mutual recognition variation procedure: Type IA / IAIN; Type IB; Type II
- Variation milestone dates
- Urgent safety restrictions
Learning objectives: After having passed this module
- you understand the procedural aspects of the variation and with regards to timelines
- you know when to implement the change
- gain insight into the milestone dates for the variations
- understand what an Urgent Safety Restriction is
Module 4: Grouping and Worksharing
Module 4: Grouping and Worksharing
- Legal context and definitions
- Grouping
- Worksharing
Module 5: Application form et cetera
Module 5: Application form et cetera
- Electronic application form; data on medicines - SPOR
- Cover letter
- eCTD requirements
- Editorial changes
Module 5a: Bonus material (in German)
Module 5a: Bonus material (in German)
recording of the webcast "Elektronische Einreichung von Variations"
- current PLM and eAF creation experiences
Module 6: Other Post-Authorisation Procedures
Module 6: Other Post-Authorisation Procedures
- Article 61(3) notifications
- Marketing authorisation validity
- Marketing status report and marketing cessation
- Renewal; Post-Authorisation Measures (PAMs)
- Repeat-Use procedure; marketing authorisation transfer; change of RMS
- Referral procedures
More options
For more information and registration simply click on this link: Regulatory Affairs Starter Pack
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
Content
The e-learning programme 'EU Variation System & Procedures' comprises six didactic modules that include videos and interactive elements in which the expert Ingrid Prieschl shares her expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.), which help you practise and apply your newly gained knowledge.
Once you have completed the six modules, you will be awarded a certificate (*), which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Your benefits
Upon completing this programme, you will:
- be able to classify and group variations;
- be knowledgeable of variation submission
- be able to handle the lifecycle of your product efficiently
You will receive a certificate after having completed the six modules and successfully passed the multiple-choice tests.
How does it work?
1. Register for an e-learning programme on our website.
2. You will receive an email with your login data for our learning platform.
3. Log in to start your e-learning programme.
4. Complete your e-learning modules at your own pace.
5. Finalise the modules with a multiple-choice test.
6. Once you have successfully completed the tests, you will be awarded a certificate (*), which you can print out.
Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.
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Further Information
Trailer EU Variation System & Procedures
Watch the trailer for our e-Learning programme "EU Variation System & Procedures".
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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