EDCTP

Universal standards for clinical trials in practice

Organised by: "Switching the Poles" Clinical Research Network
Venue: Ngurdoto Mountain Lodge, Mahale XL room (3rd floor)
Date and time: Monday 12 October: 12:00 - 14.00 hrs

Background
The "Switching the Poles" Clinical Research Network brings together researchers from Belgium, Burkina Faso, Cambodia, Cuba, DRC, Indonesia, Nepal, Peru, Uganda and Zambia. It has the aim of jointly developing capacity, tools and procedures to apply universal standards for clinical research in resource-poor settings. The Network was officially launched in 2008 as part of a programme for institutional capacity strengthening funded by the Belgian Development Cooperation and is coordinated by the Antwerp Institute of Tropical Medicine. Its motto is "Switching the Poles", and its explicit aim is to transfer not only expertise but also resources and decision-making to the South. Several network partners participate in EDCTP-funded projects, so far mainly in the field of malaria.

Subject
Universal standards for clinical trials in practice: the challenge of setting and implementing appropriate standards in externally funded clinical research projects carried out in resource-constrained settings.

Target audience
All interested participants of the EDCTP Forum.

Programme

The gap between standards and resources: lessons learned through the EDCTP-funded ABC malaria trial
Ambrose Talisuna • Medicines for Malaria Venture (MMV) Representative
in Africa, Kampala, Uganda

Double ethical review of externally funded clinical research: from recommendations to regulatory enforcement or accreditation
Anne Buvé • Department of Microbiology, Institute of Tropical Medicine Antwerp, Belgium
Pascal Lutumba • Institut National de Recherche Biomédicale Kinshasa, and University of Kinshasa, Democratic Republic of Congo

Informed consent and decision-making in vulnerable populations
Tinto Halidou • Institut de Recherche en Sciences de la Santé (IRSS)/ Centre Muraz, Burkina Faso

Responsibilities of Northern sponsors of non-commercial clinical trials in resource-constrained countries: gaps and challenges
Bruno Gryseels • Director, Institute of Tropical Medicine Antwerp, Belgium

Please note: packed lunches will be available in the Mahale XL room for participants to this satellite meeting

Registration
If you wish to attend this satellite meeting, please register through the registration form on the bottom of this page.

 

Ownership of research outcomes in sub-Saharan Africa

Organised by: EDCTP and NACCAP
Venue: Ngurdoto Mountain Lodge, Mahale XL room (3rd floor)
Date and time: Tuesday 13 October: 12.30 - 14.00.

Background
One of the major objectives of EDCTP is to accelerate the development of interventions against HIV/AIDS, malaria and tuberculosis. For EDCTP, equal and ethical partnerships between Southern and Northern research groups and between public and private organisations are a prerequisite to achieve this objective. Equality and ethics of partnerships include shared ownership responsibilities.

Many African researchers and institutions have limited expertise with protecting their intellectual property, data or research outcomes which may hamper a healthy balance between ownership and utilisation of research outcomes, including data. This area is becoming even more critical as African institutions are beginning to assume sponsorship responsibilities which require compliance with ICH-GCP guidelines. This underpins the need to support African researchers and institutions to empower them in data management, handling of intellectual property related issues, creativity and innovation.

In view of this, during the Fifth EDCTP Forum that will take place in Arusha, Tanzania from 12 to 14 October 2009, EDCTP in collaboration with NACCAP will hold a satellite meeting on ownership of research outcomes, including data management, in sub-Saharan Africa.

Objectives

• To review the current situation and to sensitise researchers on the importance of legal ownership of knowledge and research outcomes  
• To identify of gaps, challenges as well as potential solutions
• To identify the role that EDCTP, NACCAP and other partners can play in strengthening sub-Saharan the capacity for negotiating fair ownership of pre-existing knowledge and research outcomes.

Target audience
This satellite meeting will be open to all interested European and African project coordinators of EDCTP grants, especially those who are directly involved in contract negotiations, heads of research institutions, scientists and  research administrators who deal with ownership issues or data management. Representatives from (public-) private partnerships who have experience in sharing legal ownership are encouraged to share their experiences.

Programme

Welcome: objective of the meeting
Chair: Charles Mgone • EDCTP

Responsibilities of partnerships with regard to fair ownership
Marta Catarino • Universidade do Minho, Portugal

Experiences with shared ownership of data: Capacity needs of African institutions
Elly Katabira • Makerere University, Uganda

Panel discussion: Experiences from audience on shared ownership of pre-existing knowledge and research outcomes
Moderator: Janis Lazdins • WHO-TDR, Head Research & Development

Formulate ideas for action for EDCTP to strengthen fair ownership within partnerships
Chair: Charles Mgone • EDCTP

Please note: packed lunches will be available in the Mahale XL room for participants to this satellite meeting

Registration
If you wish to attend this meeting, please register using the registration form on the bottom of this page.