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Latest Webinars
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Opportunities for early dialogue with the EMA and HTA bodies. Optimizing product development to ensure…
Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful…
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Changes and Impacts of the New EU IVD Regulatory Requirements with CDx Specifics
The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These…
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MICROBIOME: Navigating Regulatory and CMC Technical Development Roadmap
Advances in genomic and big data analysis trends have significantly increased the interest of academia in the symbiotic relationship between…
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9 Challenges During Cell and Gene Therapy Development in Europe, and How to Tackle Them
Developing gene and cell-based medicinal products (referred to as “Advanced therapy medicinal products” in Europe) still represents huge challenges. At…
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FDA Consideration for e-Health
Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will…
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Efficient Drug Development for Promising Medicines: Comparative Introduction to EU & US Regulatory Tools
With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA…
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Development and Registration of m-Health Technologies for the EU Market
e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very…
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Preparing Clinical and Product Development Documentation for Public Release
The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results…
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