Ethics/Regulatory

Impact on Clinical Research of European Legislation FP7 Project Underway

Monday, June 23, 2008

The Impact on Clinical Research of European Legislation (ICREL) project is funded by the European Commission’s Seventh Framework Programme (FP7) to measure and analyze the direct and indirect impact of the European Union Clinical Trial Directive 2001/20/EC and EU-related legislation on all categories of clinical research. The one-year ICREL project is being carried out by a consortium composed of the European Forum for Good Practice (EFGCP), European Clinical Research Infrastructure Network (ECRIN), European Organisation for Research and Treatment of Cancer (EORTC), Hospital Clinic I Provincial de Barcelona and the Ethics Committee of the University of Vienna.

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AAHRPP Marching towards 2010 Goal with 22 More Accreditations

Friday, June 20, 2008

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited 22 additional organizations. In total, AAHRPP has accredited 129 organizations, representing more than 550 entities. AAHRPP’s standards exceed federal regulations. Accreditations are announced quarterly, and are valid for three years.

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Chinese Regulators, Pharma Industry Address Ethics Committee Challenges

Wednesday, May 28, 2008

A workshop held recently in Beijing presented an overview of the current ethical considerations and procedures for effectively designing, conducting and registering clinical trials in China. A key focus was clarifying the working procedures and challenges for ethics committees, also called institutional review boards, in China.

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CDER’s Woodcock Details Expanded Authority at Post-Approval Summit

Friday, May 16, 2008

Opening the Post-Approval Summit at Harvard on May 14 and 15, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

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Coast IRB Receives FDA Warning Letter

Tuesday, April 15, 2008

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter from the U.S. Food and Drug Administration (FDA) concerning the company’s improper expedited review of a phase I study being conducted in northern California. In an unusual move, the agency has temporarily suspended the IRB’s ability to do expedited reviews.

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MHRA’s New Phase I Accreditation Scheme in Effect Today

Tuesday, April 1, 2008

The Medicines and Healthcare products Regulatory Agency’s (MHRA) voluntary Phase I Accreditation Scheme went into effect today with the stated goal of formalizing routine inspections and increasing the scope and depth of inspections. Most importantly, the aim of the MHRA’s new scheme is to avoid harm to trial subjects and for handling medical emergencies during first-in-human trials should they arise.

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Project to Develop Guidelines for Health Research in Africa Launched

Monday, March 24, 2008

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa and the African Union, which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 representatives, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

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Japan’s New Regulatory Attitude Evident at DIA EuroMeeting

Wednesday, March 12, 2008

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

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