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Sponsors of Clinical Trials in the EU/EEA – Call for Action!
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?
The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often…
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Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
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How To Expedite Clinical Development Via Early Access Programs
If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
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Ask the Experts: QPPV – What is it?
Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV)…
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Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
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Regulatory pathway and agency interaction: The EU vs the US
The introduction of a new medicinal product to the US and European market follows a complex process that may extend…
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Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…