ASEAN-Japan Risk Management Plan (RMP) Symposium 2023
| Time (UTC+7) | Topic | Speaker* |
|---|---|---|
| Start at 08.45 | Participants Registration | Video Presentation & |
| Safety Induction | ||
| 09.45-09.50 | Opening | MC |
| 09.50-09.55 | Opening remarks by Mission of Japan to ASEAN | Mission of Japan to ASEAN, University Secretary of UI, Indonesian FDA |
| 09.55-10.00 | Opening remarks by University Secretary of UI | |
| 10.00-10.05 | Opening remarks by Indonesian FDA | |
| 10.05-10.20 | Photo Session | All |
| 10.20-11.10 | Session 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) ※ | ||
| 11.10-11.25 | Break | |
| 11.25-12.15 | Session 2 (Lecture 30min+Q&A 20min) | JPMA |
| 1. Development of RMP (30min) | ||
| 2. Q&A (20min) ※ | ||
| 12.15-13.30 | Lunch (Break) | |
| 13.30-15.00 | Session 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) ※ | ||
| 15.00-15.15 | Break | |
| 15.15-16.35 | Session 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) ※ | ||
| 16.35-16.40 | Closing Remarks | The Dean of Faculty of Pharmacy UI |
Language : English
ASEAN-Japan Risk Management Plan (RMP) Seminar 2023
| Time (UTC+7) | Topic | Speaker |
|---|---|---|
| Start at 08.30 | Participants Registration | Secretariat |
| 09.30-09.40 | Opening remarks | PMDA |
| 09.40-10.50 | Session 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) ※ | ||
| 10.50-12.10 | Session 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) ※ | ||
| 12.10-12.30 | Group Photo Session | |
| 12.30-13.30 | Lunch (Break) | |
| 13.30-14.00 | Session 3 (Group Work) | JPMA |
| Group Work preparation | ||
| 1. Mock RMP Development(20min) | ||
| 2. Q&A(10min) ※ | ||
| 14.00-17.10 | Session 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) |
| Time (UTC+7) | Topic | Speaker |
|---|---|---|
| Start at 08.30 | Participants Registration | Secretariat |
| 09.30-11.00 | Session 3 (Group Work, continue 90min) | Facilitator |
| 5. Group Presentation (10min/Group), | JPMA & PMDA | |
| Q&A (5min/Group) x 6 Group. ※ | ||
| 11.00-11.25 | Break | |
| 11.15-12.15 | Session 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) ※ | ||
| 12.15-13.45 | Lunch (Break) | |
| Seminar Evaluation by participants (questionnaire survey) | ||
| 13.45-14.30 | Closing Ceremony | |
| Confer Certificate | PMDA | |
| Closing Remarks | Indonesian FDA |
Language : English