Dr. Josef Hofer
exdra
Referent:innen
Dr. Wilhelm Schlumbohm
Marieke van Dalen
MARA Consultancy
Zielsetzung
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)
Hintergrund
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.
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.
Zielgruppe
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.
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
The European Variations Procedure – an Overview
- 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
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)
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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