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[e-drug] WHO-GLP Workshop in South Africa

E-drug: WHO-GLP Workshop in South Africa

27th to 29th June 2000, The President Hotel, Bloemfontein, South

Dear colleague,

I humbly invite you to participate in the above mentioned GLP training
workshop, a fulfillment of the initiative by the UNDP/World Bank/WHO
Special Programme for Research and Training in Tropical Diseases
(TDR), the details of which will be communicated to you during the
workshop. Currently, many South African institutions of higher
learning are involved in research on Malaria, Tuberculosis, HIV and
Traditional Medicines with little attention to GLP, an aspect of quality
assurance that can impede progress in drug development if not well
addressed. Furthermore, GLP is hardly mentioned during the training
of both under and postgraduate students, based on the misconception
that it applies only to drug industries or that it is too expensive to
achieve. Believe me, every laboratory requires some GLP to deliver a
quality service and only a well-informed laboratory worker will respect
them. I hope that this exercise will help us achieve the intended
objectives as set below.

Andrew Walubo 
Department of Pharmacology, University of the Free State,
P.O. Box 339 (G6), Bloemfontein 9300, South Africa.
e-mail: waluboa@frm.uovs.ac.za

Pre-clinical product development activities have traditionally been in
the domain of the pharmaceutical industry but recently have expanded
to Contract Research Organisations (CROs), most of which are located
in the North. Pre-clinical facilities and expertise are virtually
non-existent in the disease endemic countries (DEC), where most
activities of the Special Programme for Research and Training in
Tropical Diseases (TDR), are conducted. The Product Research and
Development unit (PRD) of TDR is seeking to develop products for
tropical diseases, an activity that is no longer being addressed by the
pharmaceutical industry. In this context there is need to develop
expertise and build capacity to perform such activities in the DECs.
Pre-clinical development activities are conducted following the
guidelines of Good Laboratory Practices (GLP). This is a quality system
that ensures that data produced from the toxicity studies is of high
quality and is valid. The GLP workshop is being organised as part of
technology transfer activities to introduce scientists in DECs to the
concept of GLP. This will prepare the participants to be able to
conduct GLP studies if/when the facilities are available. 

WHO/Department of Pharmacology, University of the Free State

The objective for organising GLP training workshops is to encourage
production of high quality data from pre-clinical studies. The scientists
in DECs involved in non-clinical studies will be exposed to the concept
of GLP based on the Organisation for Economic Co-operation and
Development (OECD) Principles of GLP. The role of the national
regulatory authorities in the enforcement of compliance will be
mentioned, but it will not be addressed in detail in this workshop. The
OECD Principles of GLP (1997) will be used as the model for training.

Specific objectives
To train scientists involved or who are likely to be involved in
pre-clinical studies supported by TDR on: 
- the concepts of GLP 
- preparation of GLP study plan
- preparation of SOPs

The plan is to involve participants from identified laboratories in the
country, who would be either pharmacologists/toxicologists or
pharmacokinetists. It is hoped that the participant can initiate the GLP
concepts on return to their laboratories

A three-day workshop consists of lectures and practical sessions, with
the aim of introducing the participants to GLP requirements for
pre-clinical studies. The OECD Principles of GLP will be discussed in
general and two topics (Study Protocol and Standard Operations
Procedures) in detail. The two topics to be discussed in detail will
involve lectures, discussions and practical sessions.

The workshop is designed (1) to introduce the concept of GLP to the
scientists in developing countries and (2) to assess the existing
knowledge and capacity to conduct pre-clinical studies. The following
outcomes are expected:
 - An improved understanding of the role of pre-clinical studies in
product development.
- Ability to write study protocol to GLP standard 
- Ability to write SOPs to GLP standard
- The establishment of interaction between scientists with knowledge
in GLP.


DAY 1: Tuesday, 27th June 2000
08:30 - 9:00     Registration of participants
09:00 - 9:15     Welcome and introduction ------> (Prof. Walubo)
09:15 - 10:00    Objectives of the workshop ------> (Prof. Walubo)
10:00 - 10:30    Overview of product dev't activities in TDR/PRD
                  --> (WHO representative, TDR Dept.)
                 - Discovery research
                 - Development (pre-clinical/clinical)
                 - Pre-clinical development and GLP.
10:45 - 11:45    Overview of quality and GLP 
                 --> (Prof B. Bonaschas, Head MCC/WHO QC Dep)
                 - Quality as an Ethical Consideration
                 - Quality as an Economic Necessity
                 - Quality as a Scientific Necessity
                 - Quality as a Regulatory Requirement
11:45 - 12:45    International GLP of the OECD
                 --> (Dr Van der Merwe,  Head, Sports Lab.)
                 - The basic GLP principles           
                 - The basic GLP principles
                 - The agreement of mutual acceptance of data
                 - The consensus Documents and their application
                 - The monitoring systems
14:00 - 18:00    Fundamental points of GLP 
                 Resources, --> (Dr JB Du Plesssis, Head TDM Lab)
                 Rules     --->  (Mr J Bell, Head Qual Assurance Unit)
                 Study plans or protocols
                 Standard operational Procedures (SOPs)
                 Characterisation ------> (Dr. A. Swart, Dep.Head,
                 Analytical Unit)
                 Test articles 
                 Test systems
                 Documentation --> (Dr. JM Steyn, Head, Res.Lab.)
                 Raw data, 
                 Quality Assurance ------> (Mr. Bell, Head,Q A Unit)

DAY 2: Wednesday 28th June 2000
09:00 - 10:30    The protocol or Study plan------> (Prof. Walubo)
                 - what GLP regulations require
                 - The role of the Study Director
10:45 - 12:45    Practical sessions     ------>      (Prof. Walubo)
                 - Analysis of the content and planning aspects of  2
                 Study Plans
                 - Building a Fishbone or Ishikawa diagram of the
                 Study Plans
14:00 - 12:45    Writing a Study Plan ------> (Prof. Walubo)

DAY 3: Thursday, 29th June 2000
09:00 - 10:30    Writing of SOPs        (Mr. Bell)
                 - What the GLP regulations require
                 - The document management considerations
10:45 - 10:30    Practical sessions     ------>      (Prof. Walubo)
                 - Analysis of the content and format of typical SOPs
                 - The flow chart method for the analysis of Complex
                 SOPs Writing an SOP
15:15 - 17:00    Case studies ------> (Prof. Walubo)
17:00 - 17:30    Closing of the workshop

- Registration fee: R 1800.00 before 31st March. After then, R 2000.
Strictly no registration after 26th May 1999. - Registration fee
includes all lunches, dinners and non-alcoholic refreshments from 27th
to 29th June 2000 

NB: Although the WHO is at the forefront of this activity, it could not
sponsor it due to financial shortages. But if such funds become
available, the institutions/persons attending will be refunded. A WHO
representative in charge of TDR will attend the workshop.

3. Medium of instruction: ENGLISH only


NAME              SINGLE     DBLE       B/FAST       TEL. (051)
President         R 300      R 342      included     4301111
City Lodge        R 279      R 326      R 33 pp      4442974
Holiday Inn       R 336      R 378      R 37 p.p.    4441253
Bleom.Hotel       R 360      R 390      R 40 p.p.    301911

NAME              SINGLE     DBLE       B/FAST       TEL. (051)
Hydro G/House     R 1690     R 220      included     4482974
Unitas Herberg    R 145      R 190      included     5226874
Formular 1        R 149      R 149      R 9          4443523
Altair Lodge      R 169      R 240      included     4482656

For further information, contact:
Dr. JB Du Plessis, The secretary, SA/WHO-GLP workshop committee, 
Department of Pharmacology, University of the Free State,
P.O. Box 339 (G6), Bloemfontein 9300, South Africa.
Tel (051) 401-3177; Fax: (051) 444-1523 or e-mail: 

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