The approach to extraneous agent testing in IVMPs has been updated and manufacturers of these products are required to comply with new standards from 1 July 2020.

The main programme topics include:

• A summary of revised European Pharmacopoeia requirements for extraneous agent testing, what has changed and why, with a particular focus on risk management; this is accompanied by concrete examples on how to apply the new approach.
• A session on the European regulatory landscape. The audience will have the opportunity to learn about the latest developments in the elaboration of guidance and Question & Answer documents aimed at facilitating the application of the new approach.

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Webinar 1: Setting the Scene

This webinar covers topics such as a summary of the revised Ph. Eur. requirements for extraneous agent testing, what has changed and why, with a particular focus on risk management and with concrete examples on how to apply the new approach. Includes discussions and Q&A sessions with the speakers and Ph. Eur. Experts.

Duration: 2 hours, 30 minutes.

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Webinar 2: European Regulatory Landscape

This webinar focusses on the European regulatory landscape. Participants will learn from representatives of regulatory authorities about the impact of the new approach on existing products and on best ways to apply the new approach. Includes discussions and a Q&A session with the speakers and Ph. Eur. experts.

Duration: 1 hour, 45 minutes.

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Target audience

This training is of interest to vaccine manufacturers, representatives from national and international regulatory bodies, and staff members and scientists involved in the quality control and, in particular, the extraneous agent testing of IVMPs, be it in R&D, manufacturing, regulatory affairs, quality assurance or similar functions in both industry and regulatory authorities, or sub-contracting laboratories.

Further Information

• General Presentation - Working Document: “What has changed and why?”
• Summary of the Training
• Pharmeuropa: The new approach to extraneous agent testing in immunological veterinary medicinal products (IVMPs) in the European Pharmacopoeia as of 1 July 2020
• CVMP Reflection Paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (Adopted 8 December 2016)
• EMA Guideline on requirements for the production and control of immunological veterinary medicinal products (Adopted 8 December 2016)

Other Events / Training Sessions

• Module 1: General Methods, General Chapters & General Monographs
• Module 2 : Individual Monographs