definiens: means ( a ) all laws, ordinances, rules, d irectives and regulations applicable to eTrack, the clinical Evaluation Studies or this CSSA, including without limitation applicable local laws and regulations in each relevant country in which the c linical trials are conducted or personal data of study participants is processed, ( b ) applicable reg ulations and guidelines of the U.S. Food and Drug Administration ( ) and other regulatory authori ties and applicable guidelines of the International Conference on Harmonisation of Techni cal Requirements for Registration of Pharmaceuticals for Human Use ( ) ; ( c ) as appli cable to the particular activities performed under this CSSA, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other regulato ry authorities or the ICH ; ( d ) any applicable data protection laws and regulations applicable to the clinical Evaluation Studies and the processing of personal data, including without limitation HIPA A ; and ( e ) all applicable industry and trade standards