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DARWIN EU: The Go-To Place For Real World Data

 
• By Vibha Sharma

An EU-wide network of real-world data sources will aim to become the dominant vehicle for delivering such evidence to the EMA and member countries, who have until now been using a wide range of different sources to access such data.

Big data
DARWIN EU will help EU regulators to harness big data capabilities • Source: Shutterstock

The European Medicines Agency has drawn up a five-year plan to fully implement its ambitious initiative to integrate various real-world databases across the EU under a single, secure network, called the Data Analysis and Real World Interrogation Network (DARWIN EU).

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Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

Canada’s New Rare Disease Registry Guidance To Assist Regulatory And HTA Decision Making

 
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Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

More from Clinical Trials

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.