definiens: or means the then current set of ethical and scientific qualityrequirements which must be observed for designing, conducting, recording and reporting Clinical Trialsin a given country or group of countries that involve the participation of human subjects including : ( a)in relation to Clinical Trials in the EU, Directive 2001/20 / EC, Directive 2001/83 / EC andDirective 2005/28 / EC as well as ICH - GCP and any other guidelines for good clinical practice fortrials on medicinal products in Europe as amended and applicable from time to time ; and ( b)in relation to Clinical Trials in the US, US Code of Federal Regulations Title 21, Parts 50(Protection of Human Subjects ), 56 ( Institutional Review Boards ) and 312 ( Investigational NewDrug Application ), as may be amended from time to time ; and any other guidelines for goodclinical practice for trials on medicinal products in the US as amended and applicable from timeto time ; and ( c)the equivalent Applicable Law in any other countries each as may be applicable and as amended from time to time