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Category: Government/Regulatory

Posted on November 25, 2022November 28, 2022 Europe Government/Regulatory Industry News International

DARWIN EU Names Real-World Data Partners for Federated Network

European Medicines Agency’s aim is that by 2025 DARWIN EU will deliver approximately 150 real-world evidence studies per year David Raths DARWIN EU, a federated network of real-world healthcare databases...

Posted on November 24, 2022November 28, 2022 Collaborations Competitor News Europe Government/Regulatory International

BC Platforms Partners with EU Funded, AI-Driven, Cancer Data Initiative

ZURICH, Nov. 24, 2022 /PRNewswire/ — BC Platforms (BCP), a global leader in healthcare data management and analytics, today announced that it has been chosen as key partner in a European Commission...

Posted on November 11, 2022November 13, 2022 Government/Regulatory Industry News Interviews Marketing

Bertagnolli sets out eight “core principles” for NCI: “We’ve got to be nimbler, faster”

It’s time to supercharge NCI’s role in redefining clinical trials and in strengthening the cancer research enterprise, NCI Director Monica Bertagnolli said Nov. 9 in her first director’s report. “I have...

Posted on October 27, 2022October 31, 2022 Blogs/Publications Government/Regulatory Industry News Marketing

Why collaboration is essential for using real world evidence in regulatory submissions underpinning remote patient monitoring

Connected devices are essential for the advancement of remote patient monitoring. Although medtech devices can be great for gathering data, there are many more steps required to de-silo, convert and...

Posted on October 25, 2022October 31, 2022 Competitor News Government/Regulatory

HealthVerity Achieves FedRAMP Authorized Designation

Privacy-preserving record linkage solution receives FedRAMP authorization, allowing federal agencies to securely and privately link healthcare data. PHILADELPHIA, Oct. 25, 2022 /PRNewswire/ — HealthVerity, Inc., the leader in Identity, Privacy, Governance and...

Posted on October 24, 2022October 31, 2022 Europe Government/Regulatory Industry News International

Explainer: Everything you need to know about the European Health Data Space

By Natalia Oelsner  •  Updated: 18/10/2022 Data is one of the most valuable resources in the modern world. And although digital records are constantly improving our systems, they are also raising concerns about privacy...

Posted on October 24, 2022October 31, 2022 Collaborations Competitor News Government/Regulatory International Middle East

Israeli Ministry of Health Partners with Lynx MD to Drive Innovation in Medical Research and Patient Outcomes

Israel health centers leverage Lynx MD medical platform to securely share data with MedTech, Pharmaceutical and AI researchers to transform patient care Our collaboration with Lynx will allow faster and...

Posted on October 19, 2022October 24, 2022 Government/Regulatory Industry News

Advancing Real-World Evidence Program

As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of...

Posted on October 10, 2022October 14, 2022 Europe Government/Regulatory Industry News International

High-quality data to empower data-driven medicines regulation in the European Union 

News 10/10/2022 EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the quality of the data that...

Posted on October 4, 2022October 8, 2022 Government/Regulatory Industry News

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

October 4, 2022 Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence...

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