The Symposium rundown
The Seminar rundown

ASEAN-Japan Risk Management Plan (RMP) Symposium 2023

Wednesday, 24th May, 2023
Time (UTC+7)TopicSpeaker*
Start at 08.45Participants RegistrationVideo Presentation &
Safety Induction
09.50-09.55Opening remarks by Mission of Japan to ASEANMission of Japan to ASEAN, University Secretary of UI, Indonesian FDA
09.55-10.00Opening remarks by University Secretary of UI
10.00-10.05Opening remarks by Indonesian FDA
10.05-10.20Photo SessionAll
10.20-11.10Session 1 (Lecture 30min+Q&A 20min)PMDA
Status of Risk Management Plan (RMP)
1. Strengthening Post-marketing Safety Measures utilizing Risk Management Plan
- from experiences in Japan - (30min)
2. Q&A (20min) ※
11.25-12.15Session 2 (Lecture 30min+Q&A 20min)JPMA
1. Development of RMP (30min)
2. Q&A (20min) ※
12.15-13.30Lunch (Break)
13.30-15.00Session 3 (Lecture 70min+Q&A 20min)JPMA, Indonesian FDA, PMDA, Medical Institute
Risk Minimization Approach and Review of RMP
1. Risk Minimization Approach (20min)
2. Regulator’s Perspective (30min) (Indonesian FDA & PMDA 15 min each)
3. Practical Examples of Risk Minimization Planning in Japanese Medical Institutions (20min)
4. Q&A (20min) ※
15.15-16.35Session 4 (Panel Discussion 60min+Q&A 20min)Medical Institute, JPMA, PMDA (JPMA)
1. Utilization of RMP (total 60min)
(hot topics: e-labeling 15min)
2. Q&A (20min) ※
16.35-16.40Closing RemarksThe Dean of Faculty of Pharmacy UI

Language              :  English

ASEAN-Japan Risk Management Plan (RMP) Seminar 2023

Thursday – Friday, 25th – 26th May, 2023
Time (UTC+7)TopicSpeaker
Start at 08.30Participants RegistrationSecretariat
09.30-09.40Opening remarksPMDA
09.40-10.50Session 1 (Lecture 50min+Q&A 20min)PMDA
1. How to evaluate RMP (50min)
Safety specifications
Risk Minimization Plan
2. Pharmacovigilance Plan 2. Q&A (20min) ※
10.50-12.10Session 2 (Presentation 50min+ Q&A 30min)All
1. Introduction of RMP regulatory status in each AMS (5min/AMS x 10 AMS total 50min)
2. Q&A (30min) ※
12.10-12.30Group Photo Session
12.30-13.30Lunch (Break)
13.30-14.00Session 3 (Group Work)JPMA
Group Work preparation
1. Mock RMP Development(20min)
2. Q&A(10min) ※
14.00-17.10Session 3 (continue)Facilitator JPMA & PMDA
Development of RMP
1. Participant self-introduction (10min)
2. Discussion of Risk Minimization Plan
3. Discussion of Pharmacovigilance Plan
4. Create presentation slides
(2.+3.+4. 150min in total & Mid-term break 30min)
Thursday – Friday, 25th – 26th May, 2023
Time (UTC+7)TopicSpeaker
Start at 08.30Participants RegistrationSecretariat
09.30-11.00Session 3 (Group Work, continue 90min)Facilitator
5. Group Presentation (10min/Group),JPMA & PMDA
Q&A (5min/Group) x 6 Group. ※
11.15-12.15Session 3 (wrap up total 60min)
1. Model RMP(20min)JPMA
Safety specification
Risk minimization Plan
Pharmacovigilance Plan
2. Comments from PMDA (20min)PMDA
3. Overall Q&A (20min) ※
12.15-13.45Lunch (Break)
Seminar Evaluation by participants (questionnaire survey)
13.45-14.30Closing Ceremony
Confer CertificatePMDA
Closing RemarksIndonesian FDA

Language              :  English