This education course is intended to provide guidance on the provisions laid down in the EU variations regulation and the supporting guideline. You will get to know how the regulation works and you will learn about
How to efficiently submit and process variations
Which benefits the supporting guidelines provide and how to use them
How to handle the complexity of the global supply chain
How to handle changes in API manufacturing processes
How to handle changes in packaging material
How to manage changes in ASMFs and CEPs
What is, and what is not, an established condition (EC) according to ICH Q12?
Participants will have the opportunity to choose 1 out of 2 parallel workshops dealing with
Grouping of variations
Classification of variations (APIs)
Background
Since 1 January 2010 the Commission Regulation (EC) No. 1234/2008 is binding and directly applicable in all EU member states. It defines the procedure for handling variations to the terms of marketing authorisations. Article 4 of this regulation calls for detailed guidelines explaining the different categories of variations types as well as procedural questions on the documents to be submitted in each case. These Guidelines have been consolidated in one document and published as Chapter 5 of Eudralex Volume 2A (procedures for marketing authorization) in May 2013.
The variations regulation is intended to simplify the handling of the variations procedure and to provide more flexibility in the submission and processing of variations. However, the provisions are of considerable complexity and it is important for API manufacturers and the pharmaceutical industry to be well informed about the latest status of the details of the provisions about handling changes and variations.
Additionally, the final ICH Q12 Guideline for post-approval changes was published in March 2020. The guideline introduces new concepts to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. The new ICH Q12 concepts include, for example, “Established Conditions” (ECs) and “Post-Approval Change Management Protocols” (PACMPs) to extent regulatory flexibility.
Finally, a lot of regulatory work (e.g. variations) needs to be managed due to the Brexit.
Target Group
The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the EU variations regulation, in particular for personnel from Regulatory Affairs. Furthermore, the education course will be of interest to personnel from Quality Units, Quality Control and Production of the pharmaceutical and the API Industry.
Date / Venue / Presentations / Certificate
Date Wednesday, 05 November 2025, 9.00 – 17.30 h CET (Registration and coffee 8.30 – 9.00 h) CET Thursday, 06 November 2025, 8.30 – 14.00 h CET
Venue Doubletree by Hilton Vienna Schönbrunn Schlossallee 8 1140 Vienna, Austria Phone +43/1/89110 Email info@doubletree-schonbrunn.at
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Submission and Processing of Variations – the CMDh Best Practice Guides and Explanatory Notes & ICH Q12
Best practice guides for the processing of different types of variations
Best practice guides for the processing of grouped applications
Best practice guides on worksharing and recommendations on unforeseen variations
The explanatory notes on how to complete the Variation Application Form
ICH Q12 - What is, and what is not, an established condition subject to post-approval change reporting requirements - Expected timelines for ICH Q12 implementation
The Complexity of the Global Supply Chain
The global API supply chain
How to deal with different expectations
International collaboration
Differences between registered processes
Grouping of Variations – Case Studies
Cases for grouping variations according to Article 7 in connection with Annex III of the Commission Regulation
Possibilities to combine several changes into one single application
Examples
Workshops
Exercises for grouping of variations
Exercises for classification of variations - API-related changes world wide
How to manage API Changes in a Multi-Customer Situation using ASMFs or CEPs
Why would you need to file a Change
Communication with the customers
Differences between ASMFs and CEPs
Handling National, European and Global Changes
Changes in national applications
Variations project Management
Starting and processing the notification procedure within Europe
Changes and variations in the US
Handling global changes and variations
Impact of Q8, Q9, Q10, Q12 and PAT
How to handle Changes in API Manufacturing Processes
Examples of changes
How to categorize a Change
What information to provide to whom
Variations in Packaging
Container closure systems of medicinal products
Packaging materials qualification & specification
Variations in drug product manufacturing
Regulatory documentation and strategy
ICH Q12 - Variations and Lifecycle Management
Reasons for Variations
Procedures and classifications
Type II Variations: time scales
Extension of an existing marketing authorisation
Categorisation of new applications versus variation applications
Established Conditions (ECs) and Post-Approval Change Management Protocols (PACMPs)
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
Testimonials
Seminar Programme as PDF