Common use of Applicable Law and Regulations Clause in Contracts

Applicable Law and Regulations. 11.1 The Parties shall comply with all applicable national and international laws, regulations and guidelines, especially those governing the conduct of clinical trials, dealings in medicinal products, responsibilities of clinical investigators, informed consents, protection and privacy of personal data and storage of data and records, including, without limitation, the ICH Guidelines and the European Guidelines on Good Clinical Practice (hereinafter referred to as “ICH-GCP”), Good Laboratory Practice, the revised versions of the Declaration of Helsinki Directive 95/46/EC and Directive 2001/20/EC of the European Parliament and of the Council, and professional industry association regulations.

Applicable Law and Regulations. 11.1 1.1 The Parties shall comply with all applicable national and international laws, regulations and guidelines, especially those governing the conduct of clinical trials, dealings in medicinal products, responsibilities of clinical investigators, informed consents, protection and privacy of personal data and storage of data and records, including, without limitation, the ICH Guidelines and the European Guidelines on Good Clinical Practice (hereinafter referred to as “ICH-GCP”), Good Laboratory Practice, the revised versions of the Declaration of Helsinki Directive 95/46/EC and Directive 2001/20/EC of the European Parliament and of the Council, and professional industry association regulations.