2018 APEC Harmonization Center Global Supply Chain Integrity Training August 28-30, 2018 Sheraton Seoul Palace Gangnam Hotel Seoul, Republic of Korea Dynasty Hall (B1F) (Version updated on August 5, 2018) Day 1: Tuesday, August 28th, 2018 Time Topics Speakers 09:00-09:30 Registration Sun Hee Lee (AHC) 09:30-09:45 Welcome & Opening Remarks KPBMA Ilisa Bernstein 09:45-09:55 Congratulatory Remarks (US FDA) 09:55-10:05 Group Photo 10:05-10:15 Break Introduction Ilisa Bernstein 10:15-11:00 Overview of APEC Roadmap, Toolkit, Center of Excellence (US FDA) Objectives/Expectations for the 3 days Prevention, Detection, Response FDA’s framework for Prevention, Detection, Response Ilisa Bernstein 11:00-12:00 WHO’s Guidance for Developing a National Plan for Preventing, Detecting, and (US FDA) Responding to Actions, Activities, and Behaviours that Result in Substandard Diana Lee (WHO) Falsified Medical Products” 12:00-13:30 Prevention, Detection, Response (Continue) Anthony Zook 13:30-14:30 Industry’s strategies for Prevention, Detection, Response (Merck) Introducing Pharmaceutical Management System Management of pharmaceutical manufacturing site based on risk assessment Management of imported goods: Importer Reporting System, Foreign Manufactory 14:30-15:00 Yoomi Kim (MFDS) Registration system, etc. Screening System for sale and distribution of suspicious pharmaceutical products Recall and Quality check based on Violation record, User reports, etc. 15:00-15:15 Break Supply Chain Security Toolkit Ilisa Bernstein 15:15-15:45 High-level overview of the 9 Work Streams (US FDA)
2018 APEC Harmonization Center Global Supply Chain Integrity Training August 28-30, 2018 Sheraton Seoul Palace Gangnam Hotel Seoul, Republic of Korea Dynasty Hall (B1F) (Version updated on August 5, 2018) Day 1: Tuesday, August 28th, 2018 Time Topics Speakers 09:00-09:30 Registration 09:30-09:45 Welcome & Opening Remarks Sun Hee Lee (AHC) KPBMA 09:45-09:55 Congratulatory Remarks Ilisa Bernstein (US FDA) 09:55-10:05 Group Photo 10:05-10:15 Break 10:15-11:00 Introduction Overview of APEC Roadmap, Toolkit, Center of Excellence Objectives/Expectations for the 3 days Ilisa Bernstein (US FDA) 11:00-12:00 Prevention, Detection, Response FDA’s framework for Prevention, Detection, Response WHO’s Guidance for Developing a National Plan for Preventing, Detecting, and Responding to Actions, Activities, and Behaviours that Result in Substandard Falsified Medical Products” Ilisa Bernstein (US FDA) Diana Lee (WHO) 12:00-13:30 13:30-14:30 Prevention, Detection, Response (Continue) Industry’s strategies for Prevention, Detection, Response Anthony Zook (Merck) 14:30-15:00 Introducing Pharmaceutical Management System Management of pharmaceutical manufacturing site based on risk assessment Management of imported goods: Importer Reporting System, Foreign Manufactory Registration system, etc. Screening System for sale and distribution of suspicious pharmaceutical products Recall and Quality check based on Violation record, User reports, etc. Yoomi Kim (MFDS) 15:00-15:15 Break 15:15-15:45 Supply Chain Security Toolkit High-level overview of the 9 Work Streams Ilisa Bernstein (US FDA)
AHC_Global_Supply_Chain_Integrity_Training.docx