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 (INA)
08.45 – 09.00

15

Welcome Address Siti Asfijah  (INA)
09.00 – 09.15

15

Introduction Pompini Agustina (INA)
09.15 – 10.15

60

Regulation of Clinical Trial in Indonesia Hary Wahyu (INA)
10.15 – 10.30

15

Coffee Break
10.30 – 12.00

90

GCP Principles Ria Christine (INA)
12.00 – 13.00

60

Lunch
13.00 – 14.00

60

Roles of Ethics Committee Rianto Setiabudy (INA)
14.00 – 15.00

60

Material Transfer Agreement Achmad Dinoto (INA)
15.00 – 15.15

15

Coffee Break
15.15 – 16.30

75

Roles of Key Players in Clinical Trials Atti Ratnawiati (INA)

 

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:

  1. Subject Recruitment
Hary Wahyu (INA)

30

  1. Compliance to Randomization
Hary Wahyu (INA)
09.30 –09.45

15

Coffee Break
09.45 –10.45

30

  1. Investigational Drug Handling
Atti Ratnawiati (INA)

30

  1. Serious Adverse Events Handling
Hary Wahyu (INA)
10.45 –12.00

75

Clinical Trial Facilities Endang Woro (INA)
12.00 –13.00

60

Lunch
13.00 –14.30

90

Informed Consent Endang Woro (INA)
14.30 –16.00

90

Documents Atti Ratnawiati (INA)
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

15

Closing BPOM