ICH E6 Good Clinical Practice

Target entity: ICH E6 Good Clinical Practice
Context triple: [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, notableWork, ICH E6 Good Clinical Practice]

• A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
• B. Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
  The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
• C. ISO 14971
  ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
• D. GAC Principles and Guidelines
  GAC Principles and Guidelines are a set of policy frameworks and best-practice recommendations developed to guide governments’ participation and advice on public policy issues related to the global Domain Name System within ICANN.
• E. Committee for Proprietary Medicinal Products
  The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
• F. None of above. chosen
• G. Unsure - the case is ambiguous/there is not enough information to decide.

Target entity: ICH E6 Good Clinical Practice
Target entity description: ICH E6 Good Clinical Practice is an international ethical and scientific quality standard that governs the design, conduct, recording, and reporting of clinical trials involving human subjects.

• A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
• B. Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
  The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
• C. ISO 14971
  ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
• D. GAC Principles and Guidelines
  GAC Principles and Guidelines are a set of policy frameworks and best-practice recommendations developed to guide governments’ participation and advice on public policy issues related to the global Domain Name System within ICANN.
• E. Committee for Proprietary Medicinal Products
  The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
• F. None of above. chosen