医薬品医療機器総合機構



PMDA-ATC Pharmacovigilance Seminar 2018Offered by Asia Training Center for Pharmaceuticals and Medical Devices Regulatory AffairsDate: February 5-8, 2018 Venue: PMDA Meeting Room #1-5 on 6th floorDay 1 (February 5, 2017)TimeSession10:00 - 10:05Opening 10:05 - 10:15Overview of the Seminar etc.10:15 - 11:15Overview of Pharmacovigilance11:15 - 12:15Pharmacovigilance in Japan, Europe, and the US12:15 - 13:30Lunch13:30 - 15:30Regulation on Labeling in Asia/EU/USLabeling Regulatory System in Japan vs US vs EUDrug-Drug Interaction15:30 - 15:45Break15:45 – 16:45REMS/ETASU16:45 – 18:00Introduction of Pharmacovigilance in Each Countries/Regions (Each Trainee)18:00 – 18:15Closing18:15 - Friendly Get TogetherDay 2 (February 6, 2017)TimeSession9:50 – 10:00Q&A on Day1 sessions10:00 - 11:00Safety Specification and Pharmacovigilance Plan11:00 - 12:00Risk Management Plan (RMPs) from Industry Perspective12:00 - 13:15Lunch13:15 - 16:00Workshop: Identification of Safety SpecificationHow to identify risk based on available data?16:00 - 16:15ClosingDay 3 (February 7, 2017)TimeSession9:50-10:00Q&A on Day2 sessions10:00 - 12:00Workshop: Risk Management PlanHow to create appropriate RMP?12:00 - 13:15Lunch13:15 - 15:15Workshop: Risk Management Plan (continued)15:15-15:45Feedback on the Group work & RMP (Regulator’s View Point)15:45 – 16:00Break16:00 - 17:00International Safety Data Collection17:00 - 17:15ClosingDay 4 (February 8, 2017)TimeSession9:50 – 10:00Q&A on Day3 sessions10:00 - 11:15Pharmacovigilance and Pharmacoepidemiology11:15 - 12:15Pharmacoepidemiology - The New Tool for Drug Safety Assessment - in PMDA12:15 - 13:30Lunch13:30 – 14:10Benefit-Risk Assessment through Product Lifecycle14:10 - 15:10Risk Communication of Safety Information with Patients and Healthcare Professionals15:10 – 15:25Break15:25 – 15:45Future Direction on Pharmacovigilance in Japan - Urgent Need Synergistic Collaboration -15:45 - 16:45Relief System for Adverse Health Effects in Japan16:45 – 17:10Closing Ceremony ................
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