Live Online Training: Handling Changes and Variations
Im Auftrag der ECA Academy

Live Online Training: Handling Changes and Variations Im Auftrag der ECA Academy

Seminar Nr. 17976

This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager". Learn more.

Note: All times mentioned are CEST.


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Tel.: 06221 / 84 44 0 E-Mail:


Peter Bachmann, BfArM Germany
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Josef Hofer, exdra GmbH, Germany
Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Wilhelm Schlumbohm, Berlin, Germany


This Live Online Training 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
  • What has to be considered during documentation of a variations procedure
  • How to handle changes in manufacturing procedures
  • 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?


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 has been published and is now being implemented in the ICH regions. 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) will have to be managed due to the Brexit.


The Live Online Training 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 Live Online Training will be of interest to personnel from Quality Units, Quality Control and Production of the pharmaceutical and the API industry.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme Day 1
09.00 - 09.15 h Welcome & Introduction
09.15 - 10.15 h
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
10.15 - 10.30 h Break
10.30 - 12.30 h (including 10 Minutes Break)
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
12.30 - 13.00 h
Q&A Session 1
13.00 - 14.00 h Break
14.00 - 14.45 h
Grouping of Variations – Case Studies / Examples
  • 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
14.45 - 15.45 h
How to manage changes in a multi customer situation using ASMFs or CEPs
  • Specific issues for API manufacturers
  • Need for changes
  • How to inform your customers and get feed-back
  • Differences between ASMF and CEP
  • When can you implement the change
  • Conclusions
15.45 - 16.00 h Break
16.00 - 17.00 h
Examples for classification of variations - API related changes categorization differences World Wide
17.00 - 17.30 h
Q&A Session 2
Programme Day 2
09.00 - 10.00 h
How to document a Variations Procedure
  • Documentation requirements for different types of variations
  • Timelines
  • Why a Change Control System?
  • Major parts of a Change Control SOP
  • Efficient company internal communication
  • Hints and tips for lowering the workload
  • Post Approval Change Management Protocol (PACMP)
10.00 - 10.45 h
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
10.45 - 11.00 h Break
11.00 - 12.00 h
How to handle Changes in Manufacturing Processes
  • Background
  • How to implement Changes
  • Changes in the Manufacture of APIs
  • Example: Minor change in the API synthesis
  • Example: Site change
  • Changes in the Manufacture of Drug Products
    • Example: Minor process change
  • Practical Example: Manufacturing Sites outside the EEA
    • Proof of GMP compliance of the new site
    • QP declarations
12.00 - 12.30 h
Q&A Session 3
12.30 - 13.30 h Break
13.30 - 14.30 h
How to handle Packaging Changes
  • Background
    • Packaging information in Module 3
  • How to deal with these Changes
  • Key questions
  • Practical Examples
    • Change in supplier
    • Change in the foil composition
    • Change of packaging for sterile products
14.30 - 14.45 h Break
14.45 - 15.30 h
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
  • ICH Q12: Established Conditions (ECs) and Post-Approval Change Management Protocols (PACMPs)
15.30 - 16.00 h
Q&A Session 4


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