All Veterinary medicines articles – Page 2
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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Meeting ReportVM5: Post-authorisation under Regulation 2019/6
Dries Minne opened the final session of the Veterinary Medicines Symposium 2021, covering changes to post authorisation procedures under Regulation 2019/6.
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Meeting ReportVM4: Practical implementation of the Union Product Database
This session looked at one of the main elements of the practical implementation of Regulation 2019/6, which is the creation of a Union Product Database (UPD).
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Meeting ReportVM3: Regulation 2019/6 on antimicrobials; requirements and availability
During the session, the speakers presented an overview of the new and revised rules and guidance, explored the major hurdles for new AMs, and discussed how we can protect existing AMs on the market through measures such as harmonisation of summaries of product characteristics (SPC) and flexible dosing labels.
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Meeting ReportVM1: Regulatory science – focus on biologicals
Opening the session, Ivo Claassen spoke about the unprecedented situation of the COVID-19 pandemic and the effects it has had on regulatory adaptation and emergency response preparedness. It was remarkable that novel mRNA vaccines for humans were developed and licensed in such a short period. He believes that there will be a considerable impact on the regulatory landscape in the long term.
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