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Latest Webinars
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How to master both Marketing Authorization and Joint Clinical Assessment successfully?
The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under…
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Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the…
Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various…
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Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
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Getting an Early Access Program Off the Ground Safely
Embracing an Early Access Program (EAP) presents a strategic avenue for creating valuable opportunities for patients and companies. This webinar…
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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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