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Latest Webinars
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Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
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Ask the Experts: How to use microbiome as an innovative diagnostic tool
Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
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Key CMC and NC considerations for cell and gene therapy development
ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
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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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Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
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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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Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company
Have you wondered about the role of patient engagement in healthcare product development? Currently, there is a huge emphasis on…
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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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