News

EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

The EMA/CHMP published an assessment report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines. More details can be found here.

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Literature and publications list are updated with 11 publications

The new literature and publication list on the RMM Group website was completed with new interesting reports and publications. Read more here.

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RMM database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 4 new systems, e.g. for sterility testing and Endotoxin detection. More details can be found here.

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Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

Dr Claudius Micha Nübling from the Paul-Ehrlich-Institut became member of the RMM Group Advisory Board. He will follow our longstanding Member Dr Thomas Montag. Read more here.

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New Additions to the Literature List on ECA's RMM Website

The ECA Rapid Microbiological Methods working Group added new reports and articles to the literature list on its website . More can be found here.

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Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

The FDA's CBER published their strategic plan for regulatory science and research 2012 -2016. A possible further step for implementation of modern microbiological methods? Read more.

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More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.

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FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.

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New Homepage of ECA's Rapid Microbiological Methods Working Group

The new Rapid Microbiological Working Group website is now online - providing additional information about RMM. More details can be found here.

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ECA's Rapid Microbiological Methods Conference

The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.

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