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Regulatory Update

Posted 01 January 2011 | By Michael Matthews 

The International Compilation of Human Rights Protection for 2011 is very good tool for regulatory affairs professionals who work with clinical sites around the world.The US Department of Health and Human Services (DHHS) Office for Human Research Protection (OHRP) publishes the compilation, which comprises international regulations and regulatory agencies related to human research. It includes more than 1,000 laws, regulations and guidelines that govern using human subjects in clinical research in 101 countries. The 2010 edition added five countries: Belarus, Grenada, Pakistan, Rwanda and Tunisia. The compilation is organized into five columns: country, key organizations, legislation, regulations and guidelines. The categories within each country include, if applicable, general human rights, drugs and devices, privacy/data protection, biologics, genetics, and embryos, stem cells and cloning. The publication includes many regulatory agencies' websites and links to legislation and related guidelines.


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