The first draft of updates to Annex 1, the EU’s guidance on manufacturing sterile medicinal products, was released on December 20, 2017 and took almost 14 months to review and comment on. The second targeted stakeholders’ consultation was published February 20, 2020 and is currently in circulation.
Annex 1 affects not only pharmaceuticals manufactured in the EU, but those imported by its member nations as well. By understanding the potential industry impact these revisions will have, global pharmaceutical manufacturers can prepare in advance to meet these upcoming regulatory changes. This webinar series provides a comprehensive overview of the proposed changes, with a focus on Environmental Monitoring and Quality Control.
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