ICH Guidelines definition

ICH Guidelines means the guidelines of the ICH.

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

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

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.

• Design and conduct of clinical trials to evaluate candidate medical countermeasure and device products in humans in accordance with Good Clinical Practice guidelines (GCP: as defined by 21 CFR § 312 and ICH Guidelines document E6).

• Design and conduct of Phase 1 clinical studies to evaluate the safety and pharmacokinetics of the therapeutic candidate/product in humans in accordance with Good Clinical Practice guidelines (GCP: as defined by 21 CFR §312 and International Council for Harmonization [ICH] Guidelines document E6).

• Design and execution of clinical studies/trials to evaluate the efficacy and safety of RPDs or ventilators in humans in accordance with FDA requirements and, where applicable, with Good Clinical Practice guidelines (GCP: as defined by 21 CFR §312 and ICH Guidelines document E6).

• 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).

More Definitions of ICH Guidelines

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

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

ICH Guidelines means guidelines set by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

ICH Guidelines has the meaning set forth in Section 1.100 (GCP).