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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…
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…
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…
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…
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…
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…
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…
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…