GOOD CLINICAL PRACTICE (GCP)
Posted on: March 26, 2018, by : sumedho

Workshop – 1 :
Tuesday – Thursday, 17th – 19th July 2018

Supported by:
KEPPKN, Ministry of Health Indonesian Republic and National Agency of Food and
Drugs Control (BPOM)

Objectives :

  1. To provide the basic application of clinical research and how to application
  2. To be aware of the issue of ethics & medicolegal associated with clinical research and material transfer agreement
  3. To understand how to prepare, conduct, record and report a clinical trial which protects the rights, safety and well-being of trial subjects
  4. At the end of the workshop, the participants & will be able to conduct research according to GCP guidelines

Target audience:
Everybody Involved in Clinical Research (Epidemiological, Clinical, And Physicians)

Day 1, 17th July 2018 : RS Penyakit Infeksi Prof. Dr. Sulianti Saroso, Jakarta

Time

Duration (min)

Activity

PIC

08.00 – 08.30

30

Registration

RESPINA

08.30 – 08.45

15

Welcome Address

08.45 – 09.00

15

Introduction of Good Clinical Practice Workshop

09.00 – 10.15

75

  •  The Role and Pricipal of  Ethical Clearance for Research: Scientific and Ethical Thinking
  • Case Study: Artficial Blood
  • Good Research Proposal: Application of Ethics Principal and Element of WHO Standard 2011 and 2016

10.15 – 10.30

15

Coffee Break

10.30 – 12.00

90

  • Case Study of Observational Reseach: Observation and Patients In Waiting Room
  • Case Study of Medical Record, ICU-HCU Based on Ethics Principal 2016
  • Case Study: Implementation of 7 Standards of Ethical Clearance

12.00 – 13.00

60

Lunch

13.00 – 14.30

90

  • Case Study of Subjects Recruitment: Balance of Risk and Benefit, Exploitation?
  • Case Study: Subjects Recruitment and Development Phase II (Tuberculosis Vaccine)
  • Case Study: RCT of Dopamine for Parkinson Disease

14.30 – 14.45

15

Coffee Break

14.45 – 16.00

75

  • Clinical Research and Clinical Trial: Researcher Responsibilities
  • Case Study: Cardiac Vascular Catheterization
  • Case Study: Trivalent and Pentavalent Vaccines

16.00 – 17.00

60

  • Case Study of Stem Cell: Clinical Perspectives
  • Case Study of Stem Cell: Industrial Perspectives
  • Case Study of Implant Usage

Day 2, 18th July 2018 :  RS Penyakit Infeksi Prof. Dr. Sulianti Saroso, Jakarta

Time

Duration (min)

Activity

PIC

08.30 – 09.45

75

Regulation of Clinical Trial in Indonesia

09.45 – 10.45

60

GCP Principles

10.45 – 11.00

15

Coffee Break

11.00 – 12.00

60

Roles of Investigators and Sponsor / Monitor

12.00 – 13. 00

60

Lunch

13.00 – 14.30

90

Roles of Key Players in Clinical Trials (Case Studies)

14.30 – 15.30

60

Material Transfer Agreement

 

 

Coffee / Tea Served

15.30 – 17.00

90

Facilities in Clinical Trial

Day 3, 19th July 2018  : Shangri-La Hotel, Jakarta

Time

Duration (min)

Activity

PIC

08.30 – 10.15

105

Informed Consent and Subject Recruitment

10.15 – 10.30

15

Coffee Break

10.30 – 12.00

90

Clinical Trial Documents

12.00 – 13.00

60

Lunch

13.00 – 14.30

90

Management of IP and Randomization Compliance

14.30 – 15.30

60

Management of SAE

15.30 – 16.00

30

Questionnaire / Test

16.00 – 16.30

30

Coffee Break

 

16.30 – 16.45

15

Closing