I recently had the pleasure of sitting down with Elisabethann Wright as she joined the BrightInsight Advisory Board. Elisabethann's extensive experience providing legal counsel on EU regulatory matters will be invaluable to BrightInsight and our customers. Here is some of what she shared.
I have been specialized in the EU law and regulation of the life science industry, with particular focus on the life cycle of medicinal products and medical devices, for over 35 years; in fact from the very beginning of my career when my first client was Beecham, now GSK. I have witnessed the evolution and increased sophistication both of medical devices and medicinal products and of the related laws and have had the great honor to support clients through the classification, clinical trials, authorization and launch of their products in the EU. I have also litigated aspects of the related laws before both the European Court of Justice and the EFTA Court. I have come to the stage where there is almost nothing that I have not seen before, although surprises still arise.
The interaction between medicinal products and medical devices is constantly evolving and becoming increasingly sophisticated, particularly as the role of products such as companion diagnostics grows in importance. Where this is combined with the growing impact of data privacy rules on the collection and processing of patient personal data, the BrighInsight Platform presents a very important resource for medical device and pharmaceutical companies, offering a broad, flexible and increasingly sophisticated resource in supporting the development by clients of treatment regimes that can be focused on the specific needs of individual patients.
Beautiful Murlough Bay in County Antrim, Northern Ireland for walks on the beach with family.