Meeting: Conducting and Evaluating Clinical Trials in Africa
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Source: e-drug
3rd African DIA Meeting
11 and 12 April 2001
Johannesburg, South Africa
We would like to encourage those involved in conducting and evaluat-
ing clinical trials, including regulators, policy makers and ethics
committee members, as well as investigators and applicants, to attend
this meeting which provides delegates with an update on the special
issues pertaining to clinical trials in Africa
PROGRAM
10 April 2001
Closed regulators meeting
11 April 2001
09:30 - 10:30
Opportunities and challenges of conducting Clinical Trials in Africa
Chairperson: Dr Helen Rees, MCC: South Africa
Dr Dave Lepay, Director: Division of Scientific Investigations, FDA,
USA
Dr Lindiwe Makhubalo, Department of Health, SA
11:00 - 12:30
Key criteria for successful submissions for registration
Chairperson: Dr Antoine van Gelder, MCC: South Africa
Dr Helen Rees: Chairperson: Medicines Control Council, SA
Mr Brenton James, Global Regulatory Affairs R&D, Glaxo Wellcome, UK
13:30 - 14:30
Surrogate markers in clinical trials
Chairperson: Dr David Lepay, FDA, USA
Dr Phillip Onyebujoh, Medicines Control Council Clinical Trials
committee, SA
Prof. O Duombo, University of Mali
14:30 - 15:00
Proving cost effectiveness: the fourth hurdle
Prof. David Henry, University of Newcastle, Australia
15:30 - 17:00
Panel Discussion: Proving cost-effectiveness: the fourth hurdle
Chairperson: Prof. David Henry, University of Newcastle
Dr Clas Rehnberg, Health Economics Unit, University of Cape Town
Dr Marc Blockman: Essential Drugs Program and Pharmacy & Therapeutics
Committee - W. Cape
Dr Nick Anderson, Discovery Health
Dr Indres Moodley, Searle, SA
12 April 2001
09:00 - 09:45
Opportunities and limitations of international harmonisation:
Chairperson: Dr Brenton James, Glaxo Wellcome, UK
Dr Lindiwe Makhubalo, Department of Health, SA
Dr Liz d Angelo, Astra Zeneca, Sweden
09:45 - 10:30
Safety monitoring: Are we doing it right?
Chairperson: Dr David Lepay, FDA, USA
Dr Matt Haus: Astra Zeneca, SA
Dr Ushma Mehta, National ADE Monitoring Centre, SA
10:50 - 11:40
Critical Issues in Strategic Outsourcing of Clinical trials
Chairperson: Ms Elizabeth Nettleship, Ingenix, SA
Prof. Otto Muller: South African Clinical Trials
Dr Dave Lepay, FDA, U.S.A
11:40 - 12:30
Training and accreditation: Is it needed? Who should be responsible?
Chairperson: Dr Karen Barnes, University of Cape Town, SA
Dr Maureen Joffe, Witwatersrand Health Consortium, SA
Ms Lucy Redfern, Janssen Cilag, SA
ETHICAL ISSUES: WHOSE RESPONSIBILITY?
Session Chairperson: Dr Dave Lepay, FDA, USA
13:30 - 14:15
Ethical challenges in patient recruitment
Prof. Mahomed Dada, University of Natal
Prof. Graham Lindegger, University of Natal
14:15 - 15:00
Informed Consent: Can we do better?
Prof. O Duombo, University of Mali
Prof. Snyman, South African Medical Association
15:00 - 15:45
Ensuring access to drugs for the diseases of the poor
Dr Toby Kasper, Medicins sans Frontiers
Dr Donald de Korte, MSD, South Africa
16:15 - 17:00
Panel Discussion: Ethical Issues in Clinical Trials: Addressing
questions from the floor
Chairperson: Dr Karen Barnes, University of Cape Town, SA
Dr Dave Lepay, FDA, USA
Prof. Mahomed Dada, University of Natal
Prof. O Duombo, University of Mali
Dr Graham Lindegger, University of Natal Durban
Prof. Snyman, South African Medical Association
Dr Donald de Korte, Merck, Sharpe & Dohme
Dr Toby Kasper, Medicins sans Frontiers
17:00 Closure - Dr Helen Rees
REGISTRATION FEES
DIA Members: ZAR 1,800
NON-Members: ZAR 2,000
Academia/ Government Members: ZAR 750
Academia / Government Non Members: ZAR 1,000
Registration includes workshop material, teas & luncheons, and DIA
Membership for 2001 for non-members.
SCHOLARSHIPS
Five scholarships from the DIA will be awarded on a competitive ba-
sis, with preference given to those responsible for evaluating and
regulating clinical trials in east, west and central Africa.
Continuing Professional Development Points
South African Medical practitioners should earn a total of 12 CPD
points for full attendance of this important 2 - day programme.
For further details please contact
Tracey-Kim Fourie
UCT Department of Pharmacology
Tel: +27-21-406-6294 (08.00 - 13.00 hrs.)
Fax: +27-21-448-1989
mailto:tkfourie@uctgsh1.uct.ac.za
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Dr Karen Barnes
Senior Lecturer / Clinical Pharmacologist
Department of Pharmacology
University of Cape Town Medical School
Observatory, 7925, South Africa
Tel: +27-21-406 6294
Fax: +27-21-448 6181
mailto:kbarnes@uctgsh1.uct.ac.za
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