ICH Guidelines definition

ICH Guidelines means the guidelines of the ICH.

ICH Guidelines means all relevant guidelines promulgated from time to time by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

ICH Guidelines mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline.

Examples of ICH Guidelines in a sentence

• Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations.

• Monitoring visits will be conducted by representatives of the Sponsor according to the U.S. CFR Title 21 Parts 50, 56, and 312 and ICH Guidelines for GCP (E6).

• The Investigator will ensure that this study is conducted in full conformity with relevant regulations and with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996.

• The principles of informed consent are described in ICH Guidelines for GCP.

• The medical records or other Source Documents, as defined by ICH Guidelines, that support the Study Results shall remain the property of Institution.

More Definitions of ICH Guidelines

ICH Guidelines means the then-current guidelines applicable to pharmaceutical products adopted by the International Conference on Harmonization.

ICH Guidelines means the International Council for Harmonization guidelines, as amended from time to time.

ICH Guidelines means the finalized published guidelines of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

ICH Guidelines has the meaning set forth in Section 1.67 (GCP).

ICH Guidelines means the document titled “Q7A—Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” endorsed by the International Conference on Harmonisation of Technical Requirements for Registrations of Pharmaceuticals.

ICH Guidelines means the International Conference on Harmonization Harmonized Tripartite Guideline for Good Clinical Practice.

ICH Guidelines means the guidelines of the International Conference on Harmonization.