Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in RSUP Dr. Hasan Sadikin 2018

BANDUNG – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with RSUP Dr. Hasan Sadikin on 12-13 November 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is one of the regular GCP courses held by the hospital to ensure all the clinicians and other hospital staffs trained and able to conduct clinical research. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data.

RSUP Dr. Hasan Sadikin is a government hospital located in Bandung. It is the biggest and a referral hospital to the Western Java province. This course was attended by 47 participants, which is one of the highest training participants so far. The participants are clinicians from various departments in RSUP Dr. Hasan Sadikin Bandung. They come from the group of surgery, oral surgery, urology, medical rehabilitation, physiatry, neurology, internist, cardiology, gynecology as well as skin and genital. During this event, all the participants were enthusiastically participated in all the sessions. At the end, they received both the certificate of attendance and competence.

Currently, there are over 320 hospital staffs has been GCP certified in collaboration with Prodia the CRO and IASMED at the hospital. The increase of qualified site staffs is expected to improve the running of clinical trial at the hospital supported by Clinical Research Supporting Unit (CRSU) that has been established in RSUP Dr. Hasan Sadikin.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of RSUD Dr. Soetomo – 2018 Second batch

SURABAYA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO, The Indonesian Association for The Study of Medicinals (IASMED) and RSUD Dr. Soetomo Surabaya on 16-17 October 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is aimed at improving the capacity of the site staff and increasing the chance of clinical research publication amongst clinicians in Surabaya. Ultimately, it will increase the safety and wellbeing of the clinical trial participants during the study conduct, as well as increasing the reliability of clinical trial data.

RSUD Dr. Soetomo is a teaching government hospital located in Surabaya and is a referral hospital in the Eastern Java province. This course was attended by 45 participants, one of the highest participants so far. At the end of the course, all the participants received both the certificate of attendance and competence.

Currently, there are over 450 participants has been GCP certified in collaboration with Prodia the CRO and IASMED at the hospital. The increase of qualified site staffs is expected to improve the running of clinical trial at the hospital supported by Clinical Research Unit (CRU) that has been established in RSUD Dr. Soetomo.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of RSUD Dr. Zainoel Abidin

BANDA ACEH – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO, The Indonesian Association for The Study of Medicinals (IASMED) and RSUD Dr. Zainoel Abidin Banda Aceh on 08-09 May 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site. Also, to increase the chance of publishing clinical research amongst clinicians in Banda Aceh.

RSUD Dr. Zainoel Abidin is one general hospital located in Banda Aceh, in the western of Indonesia. In this first GCP Course, there were 39 participants involved from RSUD Dr. Zainoel Abidin. Participants were varied from clinicians of different departments, pharmacists, nurses up to administrative officers who work in hospital researches. They received both the

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of HISFARSI in Eastern Java

BANDUNG – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) and HISFARSI of Eastern Java Province Chapter on 25-26 April 2018. The aim is to broaden their clinical trial knowledge and therefore the chance to become the key player in clinical trial is bigger. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site.

HISFARSI of the Eastern Java Province Chapter consists of pharmacist who works in the hospital in the Eastern Java Province. The fact that the majority of the participants are pharmacists has made this course special. The reason behind their involvement is so that the pharmacist might be able to participate in clinical trials more often and act as the key players. There were many pharmacists whose interested to join the course. However, this first GCP Course was limited for the first 44 participants from mainly RSUD Dr. Soetomo, Airlangga University Hospital and several hospitals in Surabaya. Of those 44 participants, there were the head of HISFARSI of the Eastern Java, Drs. Muhammad Yahya, Sp.FRS., Apt., and the head of pharmacy installation in RSUD Dr. Soetomo Surabaya, Drs. Ali Syamlan, Apt., SE, MARS, participating in the course. All the GCP participants received both the certificate of attendance and competence.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in Medical Faculty of Syiah Kuala University

BANDA ACEH – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) and Medical Faculty of Syiah Kuala University on 15-16 April 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site.

Syiah Kuala University is a government university located in Banda Aceh. There were many participants who interested to join the Course from both the university and Dr. Zainoel Abidin General Hospital (RSUD Dr. Zainoel Abidin). However, this GCP Course is limited for the first 40 first participants from mainly Medical Faculty of Syiah Kuala University and the rest were from RSUD Dr. Zainoel Abidin. The participants were clinicians, pharmacists, nurses and other staffs from various departments. They received both the certificate of competence and attendance.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in RSUP Dr. Soetomo – 2018 First batch

SURABAYA – The Course and Workshop on Good Clinical Practice (GCP) was held in RSUD Dr. Soetomo Hospital Surabaya on 20-21 February 2018. This course has been regularly held by PT. Prodia Diacro Laboratories (Prodia the CRO) and The Indonesian Association for The Study of Medicinals (IASMED) in collaboration with RSUD Dr. Soetomo and Medical Faculty of Airlangga University since 2015 to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the hospital. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities.

RSUD Dr. Soetomo is a government hospital located in Surabaya and is a referral hospital in the Eastern Java province. This course was attended by 41 participants. Participants were clinicians, pharmacists, nurses and other staffs from various departments. At the end of the course, all the participants received both the certificate of attendance and competence. Currently, there are over 430 participants has been GCP certified in collaboration with Prodia the CRO and IASMED.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in RSUP Dr. Hasan Sadikin 2017

BANDUNG – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with RSUP Dr. Hasan Sadikin on 28-29 September 2017. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is regularly held by the hospital to ensure all the clinicians and other hospital staffs trained and able to conduct clinical research. Hence, this ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data.

RSUP Dr. Hasan Sadikin is a government hospital located in Bandung and is a referral hospital for the Western Java province. This course attended by 16 participants from different backgrounds. Majority of the participants were clinicians, pharmacists, nurses and other staffs from various departments in RSUP Dr. Hasan Sadikin Bandung. During this event, all the participants were enthusiastically participated in all the sessions. Thus, they received both the certificate of attendance and competence.

PT. Prodia the CRO participated in FKUI Enlightenment Exhibition

FKUI enlightenment exhibition, themed “Creating the Future from the Future in Medical Research”, was held in Faculty of Medicine University of Indonesia, Salemba – Jakarta, on December 4-5, 2014.

During the event, there were medical research cluster exhibition, mini symposia and the official launch of the Medical Education and Research Center (MERC-UI).

It is planned that the research center will occupy the expected Twin Tower which will  be completed in December 2015. This research center will have 11 clusters on research, 2 clusters on supporting research and cluster on medical education. The translational research is one of the form of the research that being the primary agenda of FKUI-RSCM.

The event was attended by about 300 participants, from the university, government and industry. Ms. Endang Hoyaranda, the President Director of Prodia Group, participated as speaker in a panel session with the topic “How to establish public-private-partnership in medical research”. Her concern was the quality of the clinical study site and how it would meet the international standard of a world- class clinical trial site.

During the event, Prodia also had an exhibition booth, which was visited by many visitors, mostly researchers from University of Indonesia.

FKUI puts a high concern in developing educational and medicine research in Indonesia. Our hope is that this program would give beneficial effect on the governance of global and national health problem. Prodia, which has been acknowledged to have strong commitment in medicine research, will be on the first line to support the idea.

SMO – PT. Prodia DiaCRO Laboratories Signed the MoU with RSUP Sanglah Denpasar, Indonesia

Prodia DiaCRO Laboratories together with RSUP Sanglah Denpasar has collaborate in establishing trial site capacity building in Denpasar. This partnership established in July 3rd, 2014. The ceremony took place in RSUP Sanglah. With this collaboration, we took one step further to develop Indonesia become one of Clinical Trial potential sites destination in Clinical Trial.

SMO – PT. Prodia DiaCRO Laboratories Signed the MoU with RSUP Dr. M. Djamil Padang, Indonesia

PT. Prodia DiaCRO Laboratories collaborated with RSUP Dr. M. Djamil Padang to develop the trial site capacity building. This partnership established in April 10th, 2014. The ceremony took place in RSUP Dr. M. Djamil Padang. With this collaboration, we hope that Padang will become one of Clinical Trial potential sites destination in the future