Module 5 Presentations

05/07/2024

Recommended references (1)

• Stokes A. From Bible to EU Regulation: A brief history of the clinical trial. Regulatory Rapporteur – Vol 11, No 7/8, July/August 2014 • A Tibi, E Savage-Smith. ‘Ibn Sina’s Canon of Medicine: 11th century rules for assessing the effects of drugs’, Journal of the Royal Society of Medicine, 2009;102(2):78–80. • Fairchild AL, Bayer R. Uses and Abuses of Tuskegee. Science 7, May 1999; 284 (5416):919–921. • Lerner BH. Subjects or Objects? Prisoners and Human Experimentation. New Engl J Med. 2007; 1806–1807. • Weyers W. The Abuse of Man: An Illustrated History of Dubious Medical Experimentation. New York. Andor Scribendi, 2003. ISBN 1-893357-21-X. • Maimonides/Rambam (1135–1204). http://www.jewishvirtuallibrary.org/jsource/biography/Maimonides.html • Kim JH, Scialli AR. Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease. http://toxsci.oxfordjournals.org/content/122/1/1.full

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Recommended references (2)

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. https://www.wma.net/policies-post/wma-declaration-of helsinki-ethical-principles-for-medical-research-involving-human-subjects/ • Guideline for good clinical practice E6(R2). EMA/CHMP/ICH/135/1995. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf • https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e6-r3 guideline-good-clinical-practice-gcp-step-2b_en.pdf • https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Guideline_GCP _Video_2023_0601.mp4 • Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_pr ocedural_guideline/2012/04/WC500125437.pdf • EudraLex - Volume 10 Clinical trials guidelines. http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm

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