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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 R2 is a guideline for Good Clinical Practice (GCP) in the pharmaceutical manufacturing industry. It is a set of internationally accepted standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The guideline is intended to ensure the safety and efficacy of pharmaceutical products and to protect the rights, safety, and well-being of trial participants.
The ICH E6 R2 guideline is applicable to all clinical trials conducted in the pharmaceutical industry, including those conducted in the pre-marketing and post-marketing phases. It is also applicable to clinical trials conducted in other countries, provided that the applicable laws and regulations of those countries are followed. The guideline is applicable to all phases of clinical trials, including the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
The ICH E6 R2 guideline is widely used by pharmaceutical companies, contract research organizations, and other stakeholders in the pharmaceutical industry. Companies in the market include Pfizer, Merck, GlaxoSmithKline, Novartis, Johnson & Johnson, AstraZeneca, Sanofi, Bayer, and Eli Lilly. Show Less Read more
