 | Graeme A. Hodge - 2006 - 217 lapas
...the EU, Japan and the US in early 1990. Formalization of the meetings occurred in April 1990 through the International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH). As a joint initiative between six parties, involving both regulators (of the EU, Japan and US) and... | |
 | José Luis Valverde - 2006 - 338 lapas
...regulators and industry to discuss the interpretation of harmonized concepts to avoid diverging approaches. The International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH) provdes an example, where all regulators and industry experts from Europe, Japan and the US are brought... | |
 | Dr. Jane Barrett - 2006 - 76 lapas
...Declaration of Helsinki14, the Council for International Organisations of Medical Sciences (CIOMS), the International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH), the World Health Organisation Good Clinical Practice Guidelines15 and the European Union Clinical Trials... | |
 | 2006 - 352 lapas
...chronic toxicity testing in animals (rodent and non-rodent toxicity testing). Guidance for industry from the International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use. ICH-S5A. (Sept. 1994) Detection of toxicity to reproduction for medicinal products. Guidance for industry... | |
 | Jerry Menikoff, Edward P. Richards - 2006 - 336 lapas
...circumstances that "minimize the possibility of coercion or undue influence." 2 1 CFR § 50.20. 13. International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH), Topic E6, Guideline for Good Clinical Practice, sec. 3.1.8, available at http://www.ich.org/LOB/media/MEDIA482.pdf.... | |
 | Martin Fagan - 2006 - 24 lapas
...atwww.fda.gov/cber/guidelines.htm 4. MedDRA® Data Retrieval and Presentation: Points to Consider. International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH). 18 November 2004. Available at www.ich.org/cache/compo/608-272-1.html 5. Medic-to-Medic. Available... | |
 | Duolao Wang, Ameet Bakhai - 2006 - 497 lapas
...hosp hospitalization HRT hormone replacement therapy ICC intra-cluster correlation coefficient ICH The International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use ICH-GCP The International Conference on Harmonisation guidelines for Good Clinical Practice ICS inhaled... | |
 | Germaine Buck Louis, United Nations Environment Programme, International Labour Organisation, World Health Organization - 2006 - 352 lapas
...and international organizations, such as the USEPA, the United States Food and Drug Administration, the International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use, the EU, and the OECD, while others are still undergoing scientific evaluation. In the following sections,... | |
 | Great Britain: Parliament: House of Lords: European Union Committee - 2006 - 132 lapas
...Ethics committee review of multi-centre research. HSG(97)23. London: Department of Health, 1997. 106 International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH Harmonised Tripartite Guidelines). Guideline for good clinical practice. Geneva: IFPMA, 1997. unwise... | |
 | Adriana Petryna, Andrew Lakoff, Arthur Kleinman - 2006 - 314 lapas
...led to bias in negotiations over fair drug pricing and access. Most recently, institutions such as the International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use encourage national regulatory authorities to standardize procedures for drug testing and registration,... | |
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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use... 
