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:
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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.
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.
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.
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