The Biosimilars Opportunity – Driving Access to Treatment in Europe

The Biosimilars Opportunity – Driving Access to Treatment in Europe

Gabriela Marton, Regulatory Affairs Director and Quality Director at Arriello, highlights EU regulatory challenges and calls for policy changes and education to maximize the opportunity for biosimilars to enhance patient outcomes.

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Navigating the European Market for Medical Cannabis

Navigating the European Market for Medical Cannabis

There is considerable variation in the regulatory approach to medical cannabis between European countries. Yet, despite the complexity, there are clear routes to market, reports Peter Kohut.

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Why aren’t more companies automating PV data capture?

Why aren’t more companies automating PV data capture?

Why are Safety & Pharmacovigilance departments lagging in their application of smart technology, when the pressures on pharmaceutical organisations to capture, sift and process real-world adverse event data are vast, asks John Price, a life sciences regulatory and safety consultant and advisor to Arriello.

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Raising the bar in pharmacovigilance and regulatory outsourcing.

Raising the bar in pharmacovigilance and regulatory outsourcing.

It’s all too easy to underestimate the importance of tight project management when the work being outsourced is something other than clinical trials. Yet, whether the processes involved concern international pharmacovigilance or regulatory information filing, Anna Lukyanova, COO of Arriello, warns life sciences firms not to leave outcomes to chance.

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Bringing Biosimilars to Market in Europe

Bringing Biosimilars to Market in Europe

Biological medicines represent a major advance in the treatment of serious pathological conditions such as cancer, neurodegenerative, and autoimmune diseases. Biosimilars, as their cost-effective alternatives, improve patient access to modern therapy. As these therapeutics become trusted and more widely used by clinicians, we can expect a larger number of new biosimilars coming onto the market as the patents and market exclusivity linked to innovator products expire.