Also covering: The updated Variations Regulation and Veterinary Medicinal Products Variations
Target Group
Objectives
- 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?
- Grouping of variations
- Classification of variations (APIs)
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.
Programme
- Introduction and legal background
- General provisions of the Commission Regulation (EC) No 1234/2008
- Supporting guidelines
- Classification of variations
- Procedural handling of variations
- Grouping and worksharing of variations
- Impact of Brexit
- Conclusion and expectations
- Regulatory basis for variations to veterinary medicinal products - what are the differences to the human provisions
- Two categories of variations:
- Variations that do not require assessment (VNRA)
- Variations that do require assessment (VRA) - Veterinary variation guidance (Classification Guideline)
- 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 global API supply chain
- How to deal with different expectations
- International collaboration
- Differences between registered processes
- 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
- Exercises for grouping of variations
- Exercises for classification of variations - API-related changes world wide
- Why would you need to file a change
- Communication with the customers
- Differences between ASMFs and CEPs
- 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
- Examples of changes
- How to categorize a change
- What information to provide to whom
- Container closure systems of medicinal products
- Packaging materials qualification & specification
- Variations in drug product manufacturing
- Regulatory documentation and strategy
- 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)
Further Information
Venue
Austria Trend Hotel Savoyen
Rennweg 16
1030 Vienna, Austria
Phone: +43 (1) 20633
savoyen@austria-trend.at
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
Presentations/Certificate
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.
Conference language
The official conference language will be English.
Social Event
On the evening of the first day of the education course, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Ms Anne Günster (Operations Director), +49 (0)62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 (0)62 21 84 44 25, bauer@concept-heidelberg.de
Date & Time
(Registration/coffee 8:30 – 9:00 h)
Wed, 11 November 2026, 8:30 – 14:00 h
All times mentioned are CET.
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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