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 Santi Rahayu Dewayanti

08.45 – 09.00

15

Welcome Address Pompini Agustina

09.00 – 09.15

15

Introduction Badan POM

09.15 – 10.15

60

Regulation of Clinical Trial in Indonesia Badan POM

10.15 – 10.30

15

Coffee Break

10.30 – 12.00

90

GCP Principles Badan POM

12.00 – 13.00

60

Lunch

13.00 – 14.00

60

Roles of Ethics Committee Rianto Setiabudy

14.00 – 15.00

60

Material Transfer Agreement Herkutanto

15.00 – 15.15

15

offee Break

15.15 – 16.30

75

Roles of Key Players in Clinical Trials Badan POM

Day 2
18th July 2018 :  3rd Floor Maluku Room, Shangri-La Hotel, Jakarta

Time

Duration
(min)

Activity

PIC

08.30 – 09.30

30

Clinical Trial Management:
a. Subject Recruitment
BPOM

30

b. Compliance to Randomization BPOM

09.30 – 09.45

15

Coffee Break

09.45 – 10.45

30

c. Investigational Drug Handling BPOM

30

d. Serious Adverse Events Handling BPOM

10.45 – 12.00

75

Clinical Trial Facilities BPOM

12.00 – 13.00

60

Lunch

13.00 – 14.30

90

Informed Consent BPOM

14.30 – 16.00

90

Documents BPOM

16.00 – 16.30

30

Questionnaire BPOM

 

Day 3
19th July 2018  : RS Penyakit Infeksi Prof. Dr. Sulianti Saroso, Jakarta

Time

Duration
(min)

Activity

PIC

08.30 – 09.00

30

Presentation of Research Site, by Research Team of Sulianti Saroso Hospital BPOM

09.00 – 09.30

30

Group Tour To Facilities.
Participants will be Divided Into 2 Big Groups for Tour
BPOM

09.30 – 10.00

30

Group Observation.
Participants will be Divided Into 4 Small Groups
BPOM

10.00 – 10.30

30

Group Discussion and Report Drafting BPOM

10.30 – 11.15

45

Discussion with the Site BPOM

11.15 – 11.30

15

Evaluation of the Course BPOM

11.30 –12.00

30

Closing BPOM