IAOCR, a provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, offered comment the new EU regulation for clinical trials planned for implementation May 28, 2016.
IAOCR, a provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, offered comment the new EU regulation for clinical trials planned for implementation May 28, 2016.
Martin Robinson PhD, Executive VP & IAOCR Ambassador, commented, “These changes will work towards ensuring patient safety is at the forefront of clinical trials but the competence of those undertaking the trials is also required to ensure a robust, proficient and safe system is in place across Europe.”
The new regulation was approved by the European Parliament in April last year and has now been published in the official Journal of the European Union. It replaces directive 2001/20/EC – the Clinical Trial Directive which has been in place for almost a decade. The benefits associated with the new regulation include a single approval portal, standardized content of clinical trial applications, information about subject protection and informed consent, more stringent requirements for reporting trial progress and greater transparency about clinical trials. The regulation will be applied in full in all member states, with no need for separate national legislation and this will result in consistent and uniform application throughout EU allowing the EU Commission to conduct controls in Member States making sure that rules are properly supervised and enforced.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.