Tentative Agenda – GCP Training

Yogyakarta, 18—20 November 2022

Time Topics Facilitator

th
Day 1, Friday, 18 Nov
07:30 – 07:35 Opening
07:35 – 07:45 Sambutan pembukaan Dir. SDM RSUP DR. Sardjito
07:45 – 08:30 Introduction & Training objective dr. Jarir At Thobari, DPharm, PhD
08:30 – 10:00 Principles of Ethics & Essence of GCP dr. Jarir At Thobari, DPharm, PhD
10:00 – 10:30 Coffee break
10:30 – 11:30 Role & Responsibility of Ethical Committee Prof. dr. Madarina Julia, PhD., Sp.A(K)
11:30 – 13:00 Lunch break + Friday Pray
13:00 – 14:00 Essential Documents dr. Cahya Dewi, Sp. A(K)
14:00 – 14:45 Essential Documents: Group discussion dr. Cahya Dewi, Sp. A(K)
14:45 – 15:15 Coffee Break
15:15 – 16:00 Standard operating procedures (SOP) dr. Cahya Dewi, Sp. A(K)
16:00 – 17:00 Development of SOP: Group discussion dr. Cahya Dewi, Sp. A(K)
Day 2, Saturday, 19th Nov
07:30 – 08:30 Recapitulation Day 1
08:30 – 10:00 Informed Consent dr. Jarir At Thobari, DPharm, PhD
10:00 – 10:30 Coffee Break
10:30 – 11:30 Managing the data dr. Jonathan Hasian Haposan, MPH
11:30 – 12:30 Lunch break
12:30 – 13:30 Managing the data: Group Discussion dr. Jonathan Hasian Haposan, MPH
13:30 – 14:30 Product management dr. Dewiyani Indah W, PhD., Sp.PA
14:30 – 15:00 Coffee Break
15:00 – 16:30 Quality Management System dr. Jarir At Thobari, DPharm, PhD
Day 3, Sunday, 20th Nov
07:30 – 08.30 Recapitulation Day 2
08:30 – 09.30 Safety Management - Lecture dr. Jarir At Thobari, DPharm, PhD
09.30 – 10.00 Coffee Break
10:00 – 10.45 Safety Management - case study and DSMB dr. Jarir At Thobari, DPharm, PhD
10:45 – 11:45 Roles & responsibilities of Clinical monitor - lecture dr. Jonathan Hasian Haposan, MPH
11.45 – 12:45 Lunch
12:45 – 14.15 Roles & responsibilities of Investigator & Sponsor dr. Jarir At Thobari, DPharm, PhD
14.15 – 14.45 Wrap up and discussion dr. Jarir At Thobari, DPharm, PhD
14.45 – 15.15 Post-test and course evaluation All
15.15 – 15:30 Closing
15.30 – Coffee Break
Facilitators:
1. dr. Jarir At Thobari, DPharm, PhD
2. Prof. dr. Madarina Julia, PhD., Sp.A(K)
3. dr. Cahya Dewi Sp.A(K)
4. dr. Dewiyani Indah W, PhD., Sp.PA
5. dr. Jonathan Hasian Haposan, MPH