28
Jun
Societal Value of Generics - Lachman Blog

Societal Value of Generics

Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues. Generic medicines play […]

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25
Aug
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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24
Apr

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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