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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 development. correct answersUS, EU, Japan What happened during the birth of ICH? correct answersICH guidelines were published CTD specifications part of the guidelines ICH vs FDA guidance which to ...

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GCP (Good Clinical Practices): *Define correct answersInternational ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Objective of ICH GCP? correct answersto provide a unified standard for the EU, Japan & USA to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. ADR (Adverse Drug Reaction):*Define correct answersAll noxious and unintended re...

ICH stands for International Council for Harmonisation Regulatory Reviewers focus on Focus on study validity and results- want to see GCP used to produce high quality data based on the protocol Brainpower Read More Previous Play Next Rewind 10 seconds Move forward 10 seconds Unmute 0:14 / 0:15 Full screen Inspectors focus on Focus on study conduct and oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discu...

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 the design, conduct, monitoring, and reporting of clinical research of investigational drugs Good Clinical Practice (GCP) correct answersenhances protection of study subjects and the integrity of ...

Adverse Drug Reaction (ADR) correct answersIn the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relati...

ICH correct answersstandardize technical guidelines and requirements for drug marketing registrations, so applications for marketing to various regulatory agencies around the world can occur without redundant testing - the international standard for design, conduct, monitoring, and reporting of clinical research on investigational drugs streamlines process for developing and marketing drugs internationally Legally Authorized Representative (LAR) correct answersindividual or judicial bod...

What elements are components of an information system? correct answersOMB Circular A-130, App III: "A system normally includes hardware, software, information, data, applications, communications, and people." What are some of the threats that the information system faces? correct answersNIST SP 800-39rl, p. 1: "Threats to information and information systems can include purposeful attacks, environmental disruptions, and human/machine errors and result in great harm to the national and econo...

this legislation requires Federal agencies to develop document and implement an agency wide information security program correct answersClinger-Cohen What are the six steps of the RMF correct answersCategorize Select Implement Assess Authorize Monitor What is the term used to evaluate operational information systems against the RMF, to determine the security controls in place and the requirements to mitigate risk at a acceptable level? correct answersGap Anaylsis What is the legal ...

Clinger-Cohen Act correct answersThe following legislation requires federal agencies to establish capital planning and investment control policies and procedures when procuring information technology: Clinger-Cohen Act correct answersThe following legislation requires federal agencies to appoint a Chief Information Officer: Federal Information Security Modernization Act of 2014 (FISMA) correct answersThe following legislation requires federal agencies to develop, document and implement an ...