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CoE Activities

2019 CoE Training Schedule
Date Title Host Institution
Nov 25-29 PMDA-ATC Medical Device Seminar 2019 PMDA-ATC
Nov 11-14 2019 PKU-APEC LSIF RHSC CoE in Regulatory Science
Workshop: MRCT & Incorporating GCP-Related
Considerations
PKU
Nov 7-8 2019 Medical Device Vigilance NIDS
Oct 28-30 2019 GRM Regulatory Science CoE Pilot Workshop Thai FDA
Oct 22-24 2019 APEC Medical Devices CoE Pilot Workshop TFDA
Sep 25-27 2019 APEC CoE Pilot Training on Supply Chain Security for Medical Products Taylor's University
Sep 17-19 2019 APEC GRM CoE Workshop RAPS Taiwan
Sep 16-20 Biotherapeutics CoE Training NEU
Sep 16-18 2019 KoNECT-APEC LSIF RHSC CoE Pilot Program for
MRCT and GCP Inspection
KoNECT
Sep 4-5 2019 KIDS-APEC Pharmacovigilance CoE Training KIDS
Jul 30-Aug 1 APEC Center of Excellence pilot workshop on Advanced Therapies  NEU
Jul 11-12 MRCT-GCP CoE Training Duke-NUS CoRE
Jun 11-13 USP-APEC Center of Excellence: Minimizing Quality Risks in the Upstream and Downstream Supply Chain USP
Apr 30 - May 3 APEC RHSC Pilot CoE Workshop Medical Devices:
Medical Device 101
University of Southern California
Apr 23-25 APEC LSIF RHSC Center of Excellence in Regulatory
Sciences Pilot Workshop: Pharmacovigilance Seminar
PKU
Mar 14-15 APEC Center of Excellence on Biotherapeutics
(Industry ONLY)
NEU
Mar 11-13 APEC Center of Excellence on Biotherapeutics
(Regulator/Academia ONLY)
NEU
Feb 26-28 ICH GCP and MRCT Training: ICH E6(R2) and ICH E17 Harvard BWH MRCT Center
Feb 4-7 PMDA-ATC Pharmacovigilance Seminar 2019 PMDA ATC
Jan 21-24 PMDA-ATC MRCT Seminar 2019 PMDA ATC
2018 CoE Training Schedule
Date Title Host Institution
Oct 29-30 APEC RHSC CoE Pilot Workshop on Biotherapeutics and Biosimilars Duke-NUS CoRE
Sep 26-28 2018 APEC GRM Regulatory Science CoE Workshop RAPS Taiwan
Sep 13-14 APEC Medical Device Vigilance CoE Pilot Training NIDS
Sep 11-14 APEC Center of Excellence Workshop MRCT and Incorporating GCP-related Considerations Peking University
Sep 10-14 APEC Biotherapeutics CoE Training Northeastern University
Sep 4-5 2018 KIDS-APEC Pharmacovigilance CoE Training KIDS
Jul 23-25 APEC RHSC CoE Pilot Workshop on Advanced Therapies Duke-NUS CoRE
Apr 10-13 APEC RHSC Center of Excellence Pilot Training on MRCT-GCP Harvard BWH MRCT Center
Feb 9 APEC Regulatory Science CoE for Securing Medical Product Quality through the Supply Chain Event:
A Regulatory Policy Roundtable on Upstream Ingredient Quality
USPC
Feb 5-8 PMDA-ATC Pharmacovigilance Seminar 2018 PMDA ATC
Jan 15-18 PMDA-ATC Multi-Regional Clinical Trials Seminar 2018 PMDA ATC
2017 CoE Training Schedule
Date Title Host Institution
Dec 5-8 APEC CoE Workshop - MRCT and Incorporating GCP-related Considerations PKU
Oct 31-Nov 2 2017 APEC GRM Regulatory Science CoE Workshop TFDA & RAPS Taiwan
Sep 13-14 APEC Pharmacovigilance CoE Training KIDS
Jul 17-19 APEC RHSC CoE Pilot Workshop on Advanced Therapies Duke-NUS CoRE
Jun 26-29 APEC CoE Pilot Program for Global Medical Product Quality & Supply Chain Security UTHSC
Jun 26-28 APEC RHSC Regulatory Science CoE for GRM COFEPRIS
Mar 28-31 2017 APEC RHSC Regulatory Science CoE for Product Quality & Supply Chain USPC
Feb 6-9 PMDA-ATC Pharmacovigilance Seminar 2017 PMDA-ATC
Jan 23-26 PMDA-ATC MRCT Seminar 2017 PMDA-ATC
2016 CoE Training Schedule
Date Title Host Institution
Nov 15-17 2016 APEC Good Registration Management Regulatory Science CoE Pilot RAPS Taiwan
Nov 8-11 2016 APEC Biotherapeutics CoE Pilot SNU
Sep 13-16 2016 APEC Biotherapeutics CoE Pilot NEU
Sep 6-8 2016 APEC Pharmacovigilance CoE Pilot KIDS
Jul 12-15 APEC CoE Pilot Workshop - MRCT and Incorporating GCP-related consideration PKU
Mar 1-4 APEC RHSC Center of Excellence Workshop “Multiregional Clinical Trials” Duke-NUS CoRE
2014 CoE Training Schedule
Date Title Host Institution
Mar 17-19 APEC Multi-Regional Clinical Trials Regulatory Science Center of Excellence Pilot Workshop Duke-NUS CoRE