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Category: Europe

Posted on January 5, 2022 Europe Industry News

MHRA Guidance on the use of Real-World Data in Clinical Studies for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway

VANCOUVER, BC, Jan. 4, 2022 /CNW/ – On the 17th December 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) produced guidance acknowledging and setting out the criteria for the use of Real...

Posted on December 31, 2021January 3, 2022 Europe Government/Regulatory Industry News

UK Explains How To Plan For Randomized Trials Using Mainly RWD Sources

31 Dec 2021 NEWS  Vibha Sharma Executive Summary The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues...

Posted on December 21, 2021January 3, 2022 Europe Government/Regulatory Industry News

UK’s MHRA posts guidelines for use of real-world evidence, but med tech in limbo

By Mark McCarty The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical...

Posted on December 16, 2021December 20, 2021 Europe Government/Regulatory Industry News International

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

1. Scope This document provides an introduction to the MHRA’s real-world data (RWD) guideline series, and points to consider when evaluating whether a RWD source is of sufficient quality for the...

Posted on December 16, 2021December 20, 2021 Europe Government/Regulatory Industry News International

MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions

1. Overview This guideline is aimed at sponsors who are planning to conduct a randomised, controlled clinical trial primarily using real-world data (RWD) sources to support a regulatory decision relating to...

Posted on December 13, 2021 Collaborations Europe International Partner and Collaborator News

Palantir and STATION F Partner to Empower Early-Stage Companies

STATION F is excited to welcome Palantir Technologies as a partner of the Foster the Future initiative, which will offer workshops and conferences to early-stage companies and allow them to...

Posted on December 6, 2021 Competitor News Europe International Oncology RWE Study

Syapse Announces New Studies Published at Virtual ISPOR Europe 2021

SAN FRANCISCO, Dec. 06, 2021 (GLOBE NEWSWIRE) — Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, presented five abstracts...

Posted on December 6, 2021December 7, 2021 Competitor News Europe Fundraising/IPO International

Holmusk Announces Closing of Strategic Investment from Healthcare and Life Science Industry Leaders

NEW YORK, Dec. 6, 2021 /PRNewswire/ — Holmusk, a leading global data science and digital health company building the world’s largest Real-World Evidence (RWE) platform for behavioral health, today announced the closing of...

Posted on December 2, 2021 Academic Collaborations Competitor News Europe International

Holmusk and Charité – Universitätsmedizin Berlin Enter a Strategic Collaboration to Drive Precision Psychiatry Using Novel Real-World Data

BERLIN, Nov. 23, 2021 /PRNewswire/ — Holmusk, a leading global data science and digital health company building the world’s largest Real-World Evidence (RWE) platform for mental health, has signed a Memorandum of...

Posted on December 1, 2021December 1, 2021 Collaborations Competitor News Europe Government/Regulatory International

European Medicines Agency Selects Aetion to Support Safety and Efficacy Research in Europe

BARCELONA, Spain, Dec. 1, 2021 /PRNewswire/ — The European Medicines Agency (EMA) has selected Aetion for a four-year term to support the agency’s Quality, Efficacy, and Safety Studies on Medicines. Aetion will...

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