Wien, 17.05.2023 – Text: Catarina Carrão The patient’s voice is essential in the different regulatory activities throughout a medical product’s lifecycle. An individual’s real-life experience...
Wien, 17.05.2023 – Text: Catarina Carrão The patient’s voice is essential in the different regulatory activities throughout a medical product’s lifecycle. An individual’s real-life experience...
Wien, 17.04.2023 – Text: Catarina Carrão The U.S. Food and Drug Administration (FDA) has just released an extension to the guidance “A Risk-Based Approach to...
Wien, 22.03.2023 – Text: Susanne Mayer Arzneimittel und Medizinprodukte herzustellen und zur Zulassung zu bringen, braucht viel Zeit und noch mehr Know-how. Die Medizinerin und...
Wien, 20.03.2023 – MDR extension deadline: it’s set in stone! The European Parliament has just published in the Official Journal of the European Union the extension of the...
01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/2014 A quick guide on the rules and procedures of the updated Clinical Trials...
20.02.2023 : The most interesting clinical trials coming to an end in 2023… Recently, Nature Medicine reporters C. Arnold and P. Webster asked leading researchers to name the...
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