The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January. The revision ...
In 2014, Regulation (EU) No. 536/2014, known as the new Clinical Trials Regulation, was adopted. The goal of the regulation is to provide faster, more coordinated assessments for clinical trial ...
Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical ...
Pharmaceutical companies, researchers, and patient groups are raising concerns about new European Union regulations that could hinder the development of treatments for rare diseases. The new rules, ...
DUBLIN--(BUSINESS WIRE)--The "EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course" conference has been added to ResearchAndMarkets.com's ...
As part of a lifecycle IP strategy for a therapeutic product, it can be important to protect inventions arising during the clinical development of the product. Disclosures made during the clinical ...
Pharmaceutical industry calls for structural reforms as Dublin ranked slowest in bloc for trial start-up times, and 14th out ...
Innovations in clinical trial designs and tools have the potential to unlock a new era of research that is more convenient for patients, more reflective of real-world treatment conditions, and more ...
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