definiens: means the current good clinical practices regulations applicable to the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials as promulgated by the FDA, published at 21 C.F.R. Part 11, 50, 54, 56, 312, and 314,including applicability to foreign Data and access to original subject files and raw data by Governmental Entities and any applicable guidance, or other applicable Laws, including Guidelines of the International Council on Harmonization ( the ) ( and Guideline E6(R2 ) thereof, as atCommission Directive 2005/28 / EC, 2001/20 / EC ( insofar as currently effective ) ), 536/2014 / EU, as stated in the World Medical AssociationDeclaration of Helsinki Ethical Principles for Medical Research ( Seoul ) and all other applicable rules, regulations, orders, guidance, guidelinesor standards ( including those issued by the ICH or other Governmental Entities ), as may be amended from time to time