*Building Capacity to Enhance Ethics and Human Rights Protection of Participants in Biomedical Research
2012 Training Courses on Good Clinical Practice in Tanzania
In collaboration with AIFA, UNICRI has recently implemented a training and technical cooperation project aimed at the promotion of ethics, law and the human rights of participants in clinical research of drugs in developing countries.
In June 2012 UNICRI and AIFA organized a training course in Tanzania, upon request from the Government and in collaboration with the Tanzanian National Institute for Medical Research (NIMR) and the Bambino Gesù Pediatric Hospital in Rome.
The course, entitled "Good Clinical Practice: the promotion of international harmonization for the respect of ethical principles, human rights, and justice," was held in Mwanza, Tanzania, from 11 to 14 June, 2012.
The aim of the course was to increase the expertise of officers and professionals working in the field of pharmaceutical clinical research with human participants and strengthening knowledge of ethical, scientific, and regulatory aspects of Good Clinical Practice Guidelines. It included lecturers from prominent universities and research institutions in Africa and officials from African and European pharmaceutical regulatory agencies. The Permanent Secretary of the Ministry of Health & Social Welfare delivered a message at the opening of the course.
The training activities took place across four days, with each day divided into a theory and a practice session. The theory sessions were dedicated to all trainees, while the practice sessions saw the groups divided into two parts: The first was the Investigators, Assessors, Ethics Committees and Regulatory Group, while the second was the GCP Compliance Group.
The course laid the groundwork for establishing an African-European network of professionals trained in the international standards of clinical trials. Further action will include the delivery of the training modules to other professionals in Tanzania as well as to other countries in the region.
UNICRI received very positive feedback on the organization and the contents of the course and is, in collaboration with NIMR, planning to prepare a web-based course to make course materials permanently available to professionals in the country
| Dino Amadori, Scientific Director, IRCCS –IRST |
The natural history of tumors as a basis for controlled clinical trials: breast and cervical tumors and specific methodological aspects of clinical trials |
| Angela Del Vecchio AIFA |
GCP inspections |
| Umberto Filibeck UNICRI-OPBG |
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| Melba Gomes WHO/TDR |
Guidelines &Documents on the ethical aspects of clinical trials |
| Anna Maria Lepore OPBG Clinical & Research Services |
External Control/assessment (QA and Audit) |
| Yohana JS Mashalla University of Botswana, Botswana |
Informed Consent Process and Cofidentiality |
| Charles Mgone EDCTP |
Role of EDCTP in ethics and regulatory capacity building |
| Godwin D. Ndossi, Consultant Nutritionist, Tanzania Food and Nutrition Center, United Republic of Tanzania |
The activities and future development of GCP inspections in Tanzania |
| Ramadhani Abdallah Noor Harvard School of Public Health, United Republic of Tanzania |
No presentation file |
| Aceme Nyika Ethics Coordinator, P.H.P. Africa, Republic of Zimbabwe |
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| Maria Luisa Paoloni OPBG Clinical & Research Services |
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| Carlo Tomino AIFA |
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| Carlo Torti University of Brescia, Italy |
Randomized and controlled studies, blind and double-blind studies, non inferiority and superiority studies, BE and BA studies. Peculiarities of developing settings |
| Willem Verweij, IGZ The Netherlands |
Training Course
Programme Cover
