Call for Application to participate in the 6th Batch of Regional Course on Good Clinical Laboratory Practice (GCLP), Bhutan, November 5-7, 2019

Faculty of Post Graduate Medicine, Khesar Gyalpo University of Medical Sciences of Bhutan in collaboration with Center for Tropical Medicine (CTM), Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada with support from WHO-TDR would like to announce for the applicants for 6^th Regional course on GCLP in Thimphu Bhutan from 5^th -7^th November 2019.

Background
Good Clinical Laboratory Practice (GCLP) is a guideline in using laboratory samples for clinical studies. For some years, it has been internationally recognized that clinical laboratories processing specimens from clinical trials require an appropriate set of standards to guide good practices.

Good Clinical Practice (GCP) is not designed for laboratories and Good Laboratory Practice (GLP) focuses only on pre-clinical analyses and not on human samples from clinical trials. Therefore the British Association of Research Quality Assurance (BARQA) suggested in 2003 a guideline to close the gap. It was agreed that GCLP would be a valuable tool for improving and assuring quality laboratory practice in clinical trials. It was recognized that the GCLP Guidelines were not widely available, and it was recommended that WHO/TDR publish the guidelines on its website as the standard for laboratories undertaking samples from TDR-supported clinical trials. The TDR Diagnostics Evaluation Expert Panel (DEEP) has since recommended GCLP as the standard for clinical laboratories involved in the evaluation of diagnostics for infectious diseases. The spirit of this course is to disseminate and share the experience and knowledge on GCLP particularly in developing countries with its limitation in lab facilities.

CALL FOR 6^th REGIONAL COURSE ON GCLP
Faculty of Post Graduate Medicine, Khesar Gyalpo University of Medical Sciences of Bhutan in collaboration with Center for Tropical Medicine (CTM), Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada with support from WHO-TDR would like to announce for the applicants for 6^th Regional course on GCLP in Thimphu Bhutan from 5^th -7^th November 2019.

MODULES
Following a brief introduction which provides an overview of the course, the training will be delivered through lectures, discussion, laboratory visit and problem analysis which focuses on a series of modules:

• Personnel and Organization
• Facilities, Equipment and Supplies
• Sample Collection and Management
• Standard Operational Procedures
• Documents
• Data Recording and Reporting
• Method Validation
• Quality Assurance and Quality Control
• Laboratory Assessment

PARTICIPANTS

Target participants are those who are involved in research/clinical research with laboratory practices such as principle investigators, researchers, laboratory managers, etc.

FACILITATORS

Dr Elsa Herdiana
Dr. Herdiana is a parasitologist with vast experience of laboratory based researches. Her main research focus particularly on Neglected Infectious Diseases and Malaria.

Dra. Dewajani Purnomosari
Dra. Dewajani is a researcher who works closely in Histology and biology cell laboratory. She has experience on how to maintain quality of the laboratory research.

Prof Ritu Amatya
Professor is currently working as the Head of Department of Microbiology at NMCTH, Nepal. She is involved in diagnostic service, academics research and infection control.

SCHOLARSHIP