Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful registration. In addition, early discussion with HTA bodies and other stakeholders can be critical towards early patient access and...

The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These changes will introduce delay to market access and increased cost to CE marking IVD medical devices in Europe. As an example, there will be a...

Advances in genomic and big data analysis trends have significantly increased the interest of academia in the symbiotic relationship between the human body and its microbiome. In particular, relationship with the immune system, disease aetiology...

Developing gene and cell-based medicinal products (referred to as “Advanced therapy medicinal products” in Europe) still represents huge challenges. At the same time, these breakthrough therapies bring hope for filling unmet medical needs and...

Anastacia Bilek, Ph.D., Associate Director at VCLS, will share her experience in the regulation of m-Health products as a guide for product developers. She will discuss the definition and uses of m-Health, the regulatory environment for m-Health,...

With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA and FDA have, independently, taken measures to address this gap by enhancing the development process, leading to an increase in...

e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very often uncomfortable with the regulatory maze they have to navigate into (or...

The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results and raw data from trials sponsored by the pharmaceutical industry, as well as any document submitted to the...

Expanding product development to an overseas market can often be difficult to navigate. Thankfully we can help you to find the most effective path to realize your products’ commercial potential.

Kelsey Mower, Associate Director at VCLS will share her...

Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding of eCTD submission requirements in the various regions are important steps in filing a successful electronic...

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