Blog: Brexit Pharma Update – The EMA Survey
The results of The European Medicines Agency Brexit preparedness survey, released in July 2018, show that the majority of Marketing Authorisation Holders (MAH’s) are taking steps to make the necessary changes to their marketing authorisations.
Packing Up & Moving – The EMA in Amsterdam.
The transfer of a manufacturing process or technology from one plant to another within a company can be an arduous process. It involves careful consideration of the impact to the existing site and a rigorous selection process to ensure that...
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How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
Blog: Could the UK Continue To Be A Member of The EMA?
In this blog Brian Cleary looks at the efforts by some members of the British government to remain an active part of the European Medicines Agency.
How Are Changing Regulatory Demands Impacting You?
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In...
New Eudravigilance System Launched by EMA
The new Eudravigilance system, aimed at improving adverse event reporting and safety monitoring, was launched today (November 22nd 2017). The new system will allow for better collaboration with the World Health Organisation (WHO) by providing access to the WHO’s Uppsala...
EMA Decision Timeline: What Happens Next?
The bids are in and now the politicking begins. The EMA decision timeline is coming to an end. However, the most dramatic and interesting elements of the bid process are about to begin. We have a brief overview of...
Analysis of the Milan Bid To Host The EMA
We first wrote about Milan as a possible home for the European Medicines Agency approximately 12 months ago. The Italian city was ‘quickest out of the blocks’ in staking its claim to host the European Medicines Agency. It’s charismatic...
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