Harmonisation Study guides, Revision notes & Summaries

HFL1501 REVISION PACK. 5 PART 1 (20 marks) The origins of South African law Answer the following questions by making use only of the study material in Part 1 of the Study Guide: QUESTION 1 Answer the following questions regarding the South African Law Reform Commission that was established in 1973. 1.1 What is the task of the Law Reform Commission? (1) 1.2 Name three pieces of legislation or Bills, mentioned in Part 1 of this module, that were drafted as a result of the work of the L...

RAC-Global Regulatory Strategy Questions and Answers History of Drug Development in the US ANSWER Pure Food and Drug Act of 1906 prohibits the interstate transportation of unlawful food and drugs Federal Food, Drug, and Cosmetic Act of 1938, requiring premarket approval of all new drugs for proof of safety Kefauver-Harris Amendments of 1962, requiring demonstration of efficacy (in addition to safety) before marketing approval could be given for new drugs European Medicines Agency (EMA) ...

SOCRA - CCRP (high level) Question and answers 2023Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. rig...

ACRP-CP Exam Questions With Latest Solutions 2024 Belmont Report (1979) - answerethical principles and guidelines for the protection of human subjects of research. respect for persons - answerindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - answerA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - answerDo not harm and maximize po...

ACRP-CP Exam Questions With Latest Solutions 2024 Belmont Report (1979) - answerethical principles and guidelines for the protection of human subjects of research. respect for persons - answerindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - answerA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - answerDo not harm and maximize po...

Convention 108 was opened by who? - Answer- The Council of Europe What did the Council of Europe open for Signatories? - Answer- Convention 108 Failure to respond to the Council's 1973 & 1974 resolutions and the need for reinforcement of the principles found in those resolutions by means of a binding international instrument lead to what? - Answer- The opening of Convention 108 How many articles and parts does Convention 108 comprise of? - Answer- 27 Articles and three main parts Wh...

ICAEW – FAR, Exam Review Questions and answers, rated A+ Associates - -significant influence but not control20% ownership power to participate in policy decision b ut not control over them limitations of FS - -Backward looking exclude non financial info highly standardised aggregated info purpose of conceptual framework - -develop future IFRS promote harmonisation national standard setting bodies assist preparers of FS assist auditors assist users of FS provide info about appr...

CIPP/E Legislative Framework Exam (2023/2024) Questions and Answers(RATED A+) CIPP/E Legislative Framework Exam (2023/2024) Questions and Answers(RATED A+) Convention 108 was opened by who? - ANSWER-The Council of Europe What did the Council of Europe open for Signatories? - ANSWER-Convention 108 Failure to respond to the Council's 1973 & 1974 resolutions and the need for reinforcement of the principles found in those resolutions by means of a binding international instrument lead to ...

Good Clinical Practice (GCP) Exam Review questions and answers. Rated A+ 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 ...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...