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Latest Webinars
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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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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…
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Controversial and debated topics in Clinical Trials
A well thought out clinical strategy is critical for a clinical study, our experts of clinical study talk about the…
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Interplay between ICH and Data Privacy – GDPR
As professionals in the life sciences industry, we work in a regulated environment and we are a key element in…
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Ask the experts: EU regulatory framework for microbiome product development
Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory…
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