A Roadmap to Navigate Regulations for Clinical Trials in the European Union
Learn more about the regulations and systems that oversee clinical research within the European Union.
“The E-Book provides insights into a vital element of clinical trial conduct in Europe - regulatory framework. It covers existing procedures and challenges, an overview of upcoming changes in regulation, as well as European data protection specifics.”
Maris Veldre, Global Head of Clinical Operations
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Europe hosts world-renowned research centres and a diverse environment that can enhance the credibility of any clinical trial.
Basing your trials in Europe will:
1
Allow you to access EU-based grants and funding initiatives.
2
Give you access to large patient population via experienced and well-equipped sites.
3
Put your team within social reach of Key Opinion Leaders in all therapeutic areas.
This Guide will Give you Insights on:
Regulatory framework
All trials in the European Union need to be registered with the European Medicines Agencies. Learn about its function.
The registration process
Before getting started, your trial needs to apply for a EudraCT number. We’ll show you how to navigate this process.
Upcoming legal changes
The EU is about to implement a new unified Regulation for Clinical Trials. Find out what’s coming.
Unified information management
Soon, all clinical trials in Europe will be using the same web-based information management platform. Study what you can do with it.
Privacy regulations
Patient privacy rules in the EU are among the strictest in the world. We’ll explain what it means.
