Sentence examples for trials regulations from inspiring English sources
9 In the UK, investigational products, such as unlicensed medications and vaccines, are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004 which implement the European Clinical Trials Directive (2001/20/EC).
bIn UK for instance, the Medicines for Human Use (Clinical Trials) Regulations 2004 refer explicitly to the 'ethical principles that have their origin in the Declaration of Helsinki' (Schedule 1, pt. 2, para. 1).
Labelling, storage and preparation will be done according to the requirements of the Medicines for Human Use (Clinical Trials) regulations.
Researchers studying non-Hodgkin lymphoma, osteosarcoma, and hepatoblastoma have set a precedent for global/transatlantic studies; however, those studies were challenging due to clinical trials regulations.
In accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and Directive 2001/20/EC, the drugs under investigation in this trial fall under the definition of 'investigational medicinal product' (IMP).
The UK clinical trials regulations state that 'systems with procedures that assure the quality of every aspect of the trial should be implemented', which includes method validation (Cummings et al, 2008).
Take the clinical trials regulation, cited previously by Brexit supporters.
The outcome "could potentially affect clinical trials regulation worldwide," the announcement said.
The XWP was also expanded to include new members with expertise in animal welfare, clinical trials regulation and the management of infectious diseases (XWP 2003a, para 1.18).
EMA and the European Parliament, which approved the new European clinical trials regulation on 2 April 2014, have received praise for their leadership on facilitating access to clinical study reports.
In the EU, some clinical associations, such as the European Association for Cancer Research, had actively lobbied for the improvement of EU clinical trials regulation.
