Short Note on Regulation (EU) No 536/2014 on Clinical Trials
Regulation (EU) No 536/2014, enacted by the European Parliament and the Council on April 16, 2014, provides a comprehensive framework for the conduct of clinical trials on medicinal products for human use within the EU. It aims to ensure the protection of participants’ rights, safety, and well-being while facilitating the efficient and ethical conduct of […]
The EU Decentralised Clinical Trials Project: Revolutionizing Clinical Research
Background The landscape of clinical trials in the European Union (EU) is evolving, driven by the need for innovative trial designs and methodologies that address both emerging opportunities and inherent challenges. The EU Decentralised Clinical Trials (DCT) project is a pioneering initiative aimed at transforming the traditional clinical trial framework to enhance accessibility and convenience […]
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) What are ATMPs? Advanced therapy medicinal products (ATMPs) are a new and innovative type of medicine that uses genes, tissues, or cells to treat or prevent diseases. They work by repairing, replacing, or supplementing damaged or diseased cells and tissues. ATMPs can be used to treat a wide range of […]
Adaptive Pathways for Medicine Development
Adaptive pathways is an approach to medicine development that is based on iterative development, confirming benefit-risk balance, and gathering real world data. It applies to treatments in areas of high medical need. The European Medicines Agency (EMA) defines adaptive pathways as a flexible approach to clinical trial design, data analysis, and regulatory review that allows […]