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Latest Webinars
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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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Ask the experts: Will you be ready for the new IVD regulation?
The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies…
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Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges
The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
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How to use Scientific Advice to enhance your product development strategy
Scientific Advice (SA) is one of the important interactions a developer can have with a regulatory agency (national or European…
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Ask the Experts: How to have an effective INTERACT meeting with the FDA
INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation…
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