International Council for Harmonisation (ICH) bundled exams 2024 with 100% correct anwers

Goals of ICH correct answersTo standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing ICH E6 has become correct answersThe international standard for...

ICH stands for correct answersInternational Council for Harmonisation Regulatory Reviewers focus on correct answersFocus on study validity and results- want to see GCP used to produce high quality data based on the protocol Inspectors focus on correct answersFocus on study conduct and oversigh...

When did harmonization of regulations began? correct answers1980s Where and when was the birth of ICH? correct answersApril 1990 in Belgium What was the goal of ICH? correct answersUniform drug development standards and license application requirements Name of countries ICH covers drug deve...

International Conference on Harmonization correct answersIn 1990, a conference called the International Conference on Harmonization took place and GCP guidelines were created. According to this document, GCP is: What is GCP correct answersA standard for the design, conduct, performance, monitorin...

What is GCP? Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. What is the purpose of GCP? To provide a unified standard for the EU, Japan, and the US...

what are the three causes that led to the formation of ICH? a. lack of eligible patient to recruit, location of sites, access to treatment b. incomplete medical records, inadequate supplies, equipment not in good working order c. Insufficient laboratory data, sites not conducive to clinical trial...

Adverse Event (AE) correct answersAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (II.A.1) Adverse Drug Reaction (ADR) correct answersSubset of AE. A...

FDA correct answersFood and Drug Administration ICH correct answersInternational Conference of Harmonization - homogenized regulations in many drug markets including the US, EU, and Japan. GCP correct answersGood Clinical Practice Bioavailability correct answersThe degree to which a drug is...

Adverse Event (or Adverse Experience) correct answersAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) correct answ...

ICH is an abbreviation for: International Conference on Harmonisation International Committee on Harmonizing Research Intercontinental Committee of Health Internal Council for Healthy subjects correct answersInternational Conference on Harmonisation You are a product manager at a med...

Who was tried in the Nuremburg Military Tribunals and why? correct answersDoctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? correct answer...

declaration of helsinki (1964) correct answers-ethical principles (31) for research with human subjects -international standard -subjects take precedence -combing research and clinical care -adapted from Nuremberg Code by the World Medical Association ICH - international conference on harmo...

Why is GCP important? correct answersGCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected What are the goals of GCP? correct answers1. To protect the rights, safety and welfare of humans participating in research 2...

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 correct answersa Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (II...