Microbicides 2004 Microbicides 200428-31 March 2004, Hilton London MetropoleThe conference42 million men, women and children worldwide were living with HIV by the end of December 2002 (source: UNAIDS), including five million newly-infected during that year alone. Another 45 million people will become infected between 2002 and 2010, unless the current transmission rates can be vastly reduced. Of the 42 million, 29.4 million live in sub-Saharan Africa and 58% of them are women. Not only are women more susceptible to HIV infection, many are powerless to insist on the use of condoms or other methods of protecting themselves. In this context, and with the knowledge that an effective HIV vaccine is unlikely to be available for several years, the need for an effective topical microbicide grows ever more urgent. 2004 should prove to be a landmark year in the field of microbicide development as the first Phase III trials of novel products are due to start – the next step along the road to making a microbicide available to the millions worldwide in desperate need of protection.The aims of the Microbicides 2004 conference are to:Report novel or innovative work in the microbicides fieldProvide updates on recent microbicides research, divided into three tracks: basic science, clinical science, and behavioural science (including public health and the microbicide marketplace)Provide a forum for the discussion of new developments in microbicide research including ethical, clinical, behavioural and methodological issuesPresent opportunities for knowledge-sharing between microbicide researchers, public-health workers and advocacy organisations.There will be an opening ceremony on the evening of Sunday 28 March at which politicians, policy makers and the international media are expected. The conference will run for a full three days, each of which will contain:Scientific overviews and presentations with plenary sessions, invited lecturers and presentations of original researchWorkshops to review issues unique to microbicides such as trial design and outcome measures, and ethical issues in the clinical trials of microbicidesPoster sessions. Focus on LondonFollowing the successful Microbicides conferences in Washington in 2000 and Antwerp in 2002, March 2004 sees the focus move to London.The venue is the Hilton Metropole Hotel, two minutes by taxi from Paddington station and the Heathrow Express, with a journey time from the airport of 15 minutes. The hotel is in walking distance of Hyde Park and London’s main shopping streets, and close to Imperial College. Accommodation will be available at the venue and other hotels in the vicinity.London in March offers a variety of diversions for out-of-conference relaxation, including sight-seeing and shopping; the arts and the theatre; and pubs, clubs and restaurants to suit every taste. Conference staff will be on hand to help delegates plan their spare time.To book your place or find out more information, e-mail info@microbicides2004.org.uk or telephone the Event Office on +44 (0) 20 7720 4411
Oral: invited speaker Oral: Track A Oral: Track B Oral: Track C Poster: Track A Poster: Track B Poster: Track C Abstract only Authors

02640 CHALLENGES OF IMPLEMENTING QUALITY MANAGEMENT IN CLINICAL RESEARCH IN URBAN AND RURAL SOUTH AFRICA

Singh, Yages
Ramjee G

Introduction
Implementing the Quality Control/Quality Assurance systems and determining the accuracy of research records, varies at different sites, posing challenges especially in developing countries and more especially in rural areas. Key functional areas require close supervision and adherence. The day to day review of work for correctness and completeness involves the various components of the research process, ensuring adherence to Protocol, Policies, Standard Operating Procedures and most important compliance to Good Clinical Practices.

Challenges of Key Indicators
Quality Management is an evolving process which ensures minimum errors and discrepancies, good research practices and most important “Quality Data”. This abstract will seek to have a holistic approach of all areas of Clinical Research encompassing Good Clinical Practice, the implementation and sustainability of good Quality Management.Listed below are some of the challenges: details will be included in the full presentation if accepted.

1. Regulatory Essential Documentation - differences in requirements and stipulations from Regulatory bodies from a developed country.
2. Informed Consent Process - problems with the high level of illiteracy among participants particularly from rural areas, problems with the diversity across rural communities and language barriers.
3. Training- the unavailability of experience and expertise from the rural environment (eg. clinicians, nurses, counsellors, medical technologists etc.)
4. The lack of resources to train staff in Good Clinical and Laboratory Practices as clinical trials require international standards but people have usually adapted to local standard and practices.
5. Implementing effective GPS systems to ensure the tracking and retention of participants.
6. Lack of appropriate management tools-lack of knowledge of general office administrative functions and systems limits the implementation of adequate management tools as required by the funders.
7. Inability to develop effective tracking tools that are key instruments in follow-up and retention rate of participants.
Consideration
a) Good Clinical Practice guidelines from developed countries should take cognizance of the limitations and challenges in developing countries.
b) Appropriate capacity building (human and financial resources) is essential for the implementation of a Quality Management system.

Mrs Yages Singh
P O Box 70380, Overport, Durban 4067, Kwa Zulu Natal, South Africa
(Telephone) 27 31 2034700 (Fax) 27 31 2034702 (E-mail) yages.singh@mrc.ac.za