Harmonisation Study guides, Revision notes & Summaries

LML4810: Assignment 01 Semester 2: 2022 Unique number: QUESTION 1 Discuss the legal challenges that electronic commerce poses to consumers and businesses, also explain the extent to which the Electronic Communication and Transactions Act of 2002 has addressed these challenges. (15) The following are the challenges posed by e-commerce as noted in the Green paper: taxation; 1 intellectual-property protection; consumer protection domain naming; electronic-payment mechanisms. Eise...

Associates - Answer significant influence but not control20% ownership power to participate in policy decision b ut not control over them limitations of FS - Answer Backward looking exclude non financial info highly standardised aggregated info purpose of conceptual framework - Answer develop future IFRS promote harmonisation national standard setting bodies assist preparers of FS assist auditors assist users of FS provide info about approach to formulating IFRS Qualit...

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 oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration correct answersTrue What is the missi...

ICH stands for - Answer- International Council for Harmonisation Regulatory Reviewers focus on - Answer- Focus on study validity and results- want to see GCP used to produce high quality data based on the protocol Inspectors focus on - Answer- Focus on study conduct and oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration - Answer- True What is the mission of ICH? - Answer-...

Good Clinical Practice (GCP) Why is GCP important? - correct answer GCP 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 answer 1. To protect the rights, safety and welfare of humans participating in research 2. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical...

Good Clinical Practice (GCP) Why is GCP important? - correct answer GCP 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 answer 1. To protect the rights, safety and welfare of humans participating in research 2. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical...

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 harmonisation correct answersinternational authority on clinical research theory and principles ICH guidelines correct answers4 major categories QUALITY - chemical/pharm. Assurance (stability testin...

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. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical Practice = Ethics + Quality Data...

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. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical Practice = Ethics + Quality Data...

GOOD CLINICAL PRACTICE (GCP) QUESTIONS AND ANSWERS NEW EXAM UPDATE Why is GCP important? - GCP 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? - 1. To protect the rights, safety and welfare of humans participating in research 2. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Go...