The Day is Here – Annex 1 Revisions Take Effect - Lachman Consultants

The Day is Here – Annex 1 Revisions Take Effect

After many years of discussion and much preparation, today is the day the revised Annex 1 takes effect, August 25, 2023. Have you reviewed the revisions, considered any gaps in your organization’s operations, and developed action plans to mitigate or remediate those gaps? Do you have a complete view of your firm’s compliance with the revised Annex 1? […]

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Impact of COVID-19 on European Inspections

The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic.  The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]

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