Promoting Ethical Principles, Human Rights, and Justice in Clinical Trials in Developing Settings
International Training Course

Mwanza, 11 June 2012. UNICRI, acting in concert with the Tanzanian National Institute for Medical Research (NIMR), the Italian Pharmaceutical Agency (AIFA) and the Bambino Gesù Pediatric Hospital, has organized a new international training course on clinical trials in developing countries. The course, entitled “Good Clinical Practice: the promotion of international organization for the respect of ethical principles, human rights, and justice,” is taking place in Mwanza, Tanzania, from 11-14 June, 2012.

In the era of globalization, the spread of biomedical research with human subjects poses challenges at various levels, in particular since it can involve the risks of fraudulent behavior, non-compliance with the standards of ethical reviews and lack of control of the quality of drugs and/or of the established protocols. The growing number of clinical trials conducted in developing settings, in particular in Latin America, Africa and Asia, requires total commitment from all stakeholders to ensure the correct application of good clinical practices and adherence to internationally recognized principles of ethics, human rights and justice.

In recent years, UNICRI, in collaboration with AIFA has investigated the ethical and legal issues surrounding the conduct of clinical trials with human participants in developing countries, with particular regard to its criminal implications.

The international course in Tanzania represents the first outcome of UNICRI and AIFA assessments. It aims at increasing professional expertise of officers and professionals working in the field of clinical research of drugs with human participants and strengthening knowledge of ethical, scientific, and regulatory aspects of Good Clinical Practice. The course involves lectures from prominent researchers and officials in the field. Additionally, the course hopes to lay the groundwork for establishing an African-European network of professionals trained in the international standards of clinical trials. UNICRI and AIFA aim that such a network will contribute towards the ongoing understanding, recognition, and promotion of international principles and Best Practices sharing.

For more information, please contact Marina Mazzini. E-Mail: - Tel: +39 011 6537141

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