Background

  • Establishment of CTWG (Clinical Trial Working Group) to establish guidelines for Good Clinical Practice (CUKB) in Indonesia in accordance with the Decree of Head of BPOM
  • Endorsement of CUKB Indonesia in 2001 and its implementation since 2001 until now, followed by the issuance of CUKB English version in 2006
  • The development of clinical trial activities in Indonesia in accordance with the development of medical science / pharmaceutical industry locally and globally
  • Potentiality and benefits of clinical trials conduct that have not been fully explored in Indonesia and the lack of information about the process of conducting clinical trials in Indonesia
  • Growing need for information, education, advocacy and exploration in the implementation of clinical trials in Indonesia
  • Concern of some practitioners in the clinical trials field to establish an organization with a mission to promote the activities and all aspects related to clinical trials in Indonesia.



History
Chronology up to the formation of IASMED

  • July 2000 - Establishment of CTWG (Clinical Trial Working Group) to design Pedoman Cara Uji Klinik yang Baik (CUKB) in Indonesia which adheres to the International standards of GCP (Good Clinical Practice), in cooperation with National Agency of Drug and Food Control (NADFC) / Badan Pengawas Obat dan Makanan (BPOM) in accordance with the Decree of the Head of Badan POM Number HK .00.06.2.02644 dated July 31, 2000.
  • February 2001 - Implementation of the legal framework of clinical trial procedures by Badan POM, which was stated in the Decree of the Head of Badan POM No. 02002/SK/KBPOM dated February 28, 2001, which imposed Pedoman Cara Uji Klinik yang Baik (CUKB) in Indonesia.
  • April 2001 – First publication of Pedoman Cara Uji Klinik yang Baik (CUKB) di Indonesia by Badan POM, in collaboration with CTWG.
  • May 2001 - Workshop for the Ethics Committees from some medical schools in Indonesia and auditors / inspectors, in collaboration with Badan POM and the National University Hospital (NUH), Singapore.
  • January 2006 – Publication of Pedoman CUKB English version by Badan POM "The Indonesian Guidelines for Good Clinical Practice", in collaboration with CTWG.
  • 2001-2009 – Organized several trainings for clinical trials practitioner, such as the sponsor (clinical research associates / CRAs, project leaders, study physicians, etc), and researchers (principal investigators, co-investigators and Clinical Research Coordinators / CRCs), by CTWG together with various parties such as Badan POM, Medical schools, Medical Associations (IDI) , PEDFI, pharmaceutical industry, pharmaceutical industry associations, and others.
  • September 2009 – Brought up the idea of IASMED formation at the meeting which was attended by several members of CTWG in Jakarta, on September 28, 2009.
  • December 2009 - Approval of the idea IASMED formation by the meeting which was attended by members and non-members of CTWG in Jakarta on December 17, 2009.
  • January 2010 - Formation of IASMED Establishment Committee, composed of members and non-members of CTWG, chaired by Prof. Rianto Setiabudy.
  • March 2010 - Submission of the candidates’ names of first IASMED Chairman, along with the candidates for the Advisory Board, Board of Trustees and Executive Board. Meeting on March 30, 2010 by acclamation appointed the first Chairman and Secretary-General for the 2010 to 2012 period and subsequently obtained a mandate to establish the Executive Board.
  • May 3, 2010 - Signing of the IASMED Deed of Establishment in Jakarta. IASMED is an independent organization with patronage of CTWG, and its members consist of members and non-members of CTWG.
  • June 19, 2010 – Planned for IASMED inauguration, follow with the first IASMED Scientific Seminar in Jakarta.