Ethics, human rights and justice in clinical research of drugs in developing countries

Training Course on Good Clinical Practice - Towards the creation of an African-European network, Mwanza, Tanzania, 11-14 June, 2012

UNICRI, in collaboration with the Tanzanian National Institute for Medical Research (NIMR), the Italian Medicines Agency (AIFA) and the Bambino Gesù Pediatric Hospital, has organized a training course on respecting ethical principles and justice while conducting clinical trials in developing countries. 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 11-14 June, 2012.

The course aimed at increasing 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. The course 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 course 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 has 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 and eventually to other countries in the Region.

UNICRI received very positive feedback on the organization and the contents of the course, and is planning to prepare in collaboration with NIMR 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


GCP inspections

Umberto Filibeck


  1. General aspects and principles of ich-gcp

  2. The respect of ethics and gcp in the E.U

  3. Role duties and responsibilities of CTs personnel

  4. Inspection of independent ethics committees (iec)

  5. Organisation of gcp inspections_Filibeck

Melba Gomes


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


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

  1. Vulnerable population

  2. informed consent

Maria Luisa Paoloni

OPBG Clinical & Research Services

  1. The role, duties and responsibilities of clinical trials personnel – Sponsor

  2. The role, duties and responsibilities of clinical trials personnel – Monitoring: rules and recommendations

  3. Monitoring rules – setting up the monitoring plan

Carlo Tomino


  1. Operational aspects of a clinical trial

  2. Insurance

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

  1. The five Ws of the inspection mechanism: who, what, where, when, why

  2. Inspections: findings and grading, outcomes, critical issues and decisions

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