B.P. Koirala Institute of Health Sciences

Ghopa, Dharan, Nepal

GCP 2017 BPKIHS

DESCRIPTION

B. P. Koirala Institute of Health Sciences, Dharan, Nepal has been designated for conducting the 3rd 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. The 1st and 2nd batch of Regional Course on Good Clinical Practice (GCP) was conducted successfully at UGM Yogyakarta, Indonesia. BPKIHS is proudly calling for applicants to participate in the 3rd Batch of Regional Course on GCP that will be held on July 31- August 2, 2017 in Nepal. WHO/TDR through BPKIHS invites potential candidates to apply for the course and scholarships are available for 7 successful applicants.

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.

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 : Dr. Thobari is a Pharmacologist who has been involved in more than 25 GCP both national and international trainings in the last 4 years. He has extensive experience in running clinical trials such as Rotavirus Vaccine Clinical Trial in Indonesia.

Dr. Varalaksmi Elango : Dr Elango is Independent WHO/TDR GCP and GCLP consultant who has vast experience in developing and facilitating international GCP and GCLP courses.

Prof. Dr. Suman Rijal : Prof. Dr. Suman Rijal is the Managing Director of Regional Office of Drugs for Neglected Disease initiative (DNDi) in New Delhi, India. Before joining DNDi he was Professor of Internal Medicine and Chief, Tropical and Infectious Diseases Centre, at B.P. Koirala Institute of Health Sciences, Nepal where he has been a faculty since 1997.Since the last 15 years he has been working in the field of neglected tropical diseases particularly kala-azar. He has coordinated several collaborative research projects and participated in the developments of guidelines for the control of kala-azar in the region. He is a member of several national and international committees including the WHO Expert Panel on Parasitic Diseases (Leishmaniasis), Geneva, and Regional Technical Advisory Group on VL Elimination at SEARO/WHO.

Dr. Jyotsna Rimal, Course co-ordinator : Dr. Jyotsna Rimal is an Oral Physician involved in many clinical researches on oral mucosal lesions and oral manifestation of systemic diseases and orofacial pain. She has been involved in Health Research Capacity building committee of the institute to conduct health research trainings.

SPONSORSHIP

Sponsorship will cover: course fee (all inclusive), ticket (economic fare), lump sum and accommodation

Eligibility for the Scholarship:

  • Only applicants from countries of South-East Asia Region (SEAR) are eligible
  • Participants are those who have been involved in research such as investigators, clinicians, pharmacists, other health professionals, research staffs, sponsors, ethics committee, etc.
  • Applicants must be in group of 2-3 people per institution

REGISTRATION

This 3rd Batch of Regional GCP Course is designed as a 3 day intensive program with a maximum of 25 participants.

Registration open : May 20 – July 10, 2017

Course fee per person and deadline

SponsorshipMay 20 – June 20, 2017FREE
Early Bird May 20 – June 30, 2017 (extended till 5thJuly 2017)NPR 34,000/- (US$ 320)
NormalJuly 1 – 10, 2017NPR 42,000/- (US$ 400)

*ticket, accommodation and lump sum are not included

Application Requirement: Application form (can be downloaded here), CV, motivational letter, recommendation letter, and copy of passport (international participants). Sponsorship applicants must complete and send the documents by email to gcp@bpkihs.edu at the latest on June 20, 2017

Announcement of Scholarship for GCP 2017