Evolution of the European regulatory framework for innovation

DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology assessment (HTA) bodies, patient advocacy groups, and other critical stakeholders. Presentations covered the entire healthcare value chain, ranging from policy and regulations to research and development, marketing and access.

In this report, focus will be given to presentations addressing the evolution of the European regulatory framework to support continued innovation. This covers the development of novel medicinal products, devices, diagnostics, together with the application of real world data (RWD) to ensure patients benefit from the potential these technologies offer.

In the opening session, four priorities were identified, and as these are applicable for all stakeholders, they will be discussed in more detail.


Chris Wilson, B.Sc., M.Sc., MTOPRA, Senior Director, Drugs & Biologics

Chris has two responsibilities within Voisin Consulting Life Sciences (VCLS). As Senior Director, he manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics; and as Head, Medical Writing, he provides leadership for this function.


Hélène Lafolly, Pharm.D, MSc, Senior Regulatory Scientist, Complex biologics 

As a Senior Regulatory Scientist, Complex Biologics at VCLS, Hélène works in close collaboration with life sciences companies to provide strategic input and regulatory support for the development of innovative products such as ATMPs, blood derived products, allergenics and vaccines, in both Europe and the US.


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