CALL FOR APPLICATION TO PARTICIPATE IN

THE 7th BATCH OF REGIONAL COURSE ON

GOOD CLINICAL PRACTICE
PALEMBANG-INDONESIA
November 26-28, 2021

DESCRIPTION
Regional Training Center, Center for Tropical Medicine has been designated for conducting the 7th batch of regional courses
on GCP by TDR for the South East Asia Region with a mandate to improve research capacity skills of researchers in the region.
Good Clinical Practice is an international ethical and scientific standard for designing, conducting, analyzing and reporting
clinical trials that involve participation of human subjects. Compliance with this standard provides public assurance that the
rights, safety, and well being of trial subjects are protected. It also ensures the credibility of the trial data. The subject of GCP
has become an international significance. Sponsors of clinical research generally demand that all research activities must be
delivered according to the GCP standard.
This course was designed to set the stage for GCP training by providing the background understanding of how the concept of
GCP has evolved to where it is now. The module provides an overview of what forces led to the landmark International
Conference on Harmonization (ICH) that triggered the GCP. A special focus is dedicated to developing country research and
development activities whose researchers are compelled to adhere to GCP in environments that may not be easily conducive
to GCP requirements.

MODULES
Following a brief introduction which provides an
overview of the course, the training focuses on a series
of modules:
History and Principles of GCP
Quality system in clinical research
Principles of research ethics
Essential documents
Stakeholders responsibilities
GCP in Trial procedures
Informed consent process
Safety management
Investigational product management
Data management
The overall training approach used in these modules is
based on adult learning principles. Methods would
comprise a combination of interactive lectures,
discussions, practical exercises – small group work,
role-plays and preparation/review of records.
REGISTRATION
This 7th Batch of Regional GCP Course is designed as 3 days
intensive program with a maximum of 20 participants.
Registration open: October 27-November 19, 2021
PARTICIPANTS
Target participants are those who are involved in
research such as investigators, clinicians, pharmacists,
other health professionals, research staffs, sponsors,
ethics committee, etc.
FACILITATORS
dr. Jarir At Thobari, DPharm, Ph.D
dr. Jonathan Hasian Haposan, MPH
Muh. Ridwan Anshori, Sgz., M.Gizi
SPONSORSHIP
Sponsorship (free registration: inc.course fee, meals (two
tea/coffee break, lunch) during the workshop, not included
accommodation and travel expenses)
Eligibility for the Scholarship:
1. Participants are those who have been involved in
research such as investigators, clinicians, pharmacists,
other health professionals, research staffs, sponsors,
ethics committee, etc.
2. Applicants must be in group of 2-3 people per
institution

Pusat Kedokteran Tropis UGM, Gedung Litbang FK-KMK UGM lt. 2. sayap utara. Jl. Medika, Senolowo, FORM DOWNLOAD

Mlati, Sleman, Yogyakarta 55281

CP : Septi Rusdiyana (septi.rusdiyana@yahoo.com)

Telp : (0274) 547147 Fax. 547147 - HP : 08112847147
Email : training-pkt.fkkmk@ugm.ac.id
Download form at : https://bit.ly/GCP-Regional
centertropmed-ugm.org/