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Latest Webinars
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…
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…
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…
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…
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…
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…
10 Things to Know Before Entering the European Market
Expanding product development to an overseas market can often be difficult to navigate. Thankfully we can help you to find…
Managing a Global Publishing Strategy
Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding…