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.
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.
Testimonials
Seminar Programme as PDF