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Navigating the Changes to the EU Clinical Trials Regulations 536/2014 – Managing the Application and Authorisation Process
The processes for applying for and authorizing clinical trials in Europe have, traditionally, held numerous inefficiencies. Currently governed under the Clinical Trial Directive 2001/20/EC, trial sponsors have been required to submit separate applications for each member state in the European Economic Area (EEA) where they planned to conduct a study.
Managing the New EU Clinical Trials Regulation 536/2014 – Guidance for Navigating the Clinical Trial Information System (CTIS)
Staying on top of global regulatory guidelines and compliance is challenging for every organization working in the clinical research industry. Leaders from THREAD recently attended a comprehensive training session around the new Clinical Trial Regulation 536/2014 held by the European Medicines Agency (EMA) in order to help our global customers effectively navigate the changes associated with the new guidelines.