2019 APEC CoE Pilot Training on Supply Chain Security for Medical Products
Day 1: Wednesday, September 25th, 2019
08:30 Bus pick-up from Sunway Clio Hotel and transport to Taylor’s University
09:00 Registration, Welcome and Introduction
09:35 Welcoming speeches and Opening Remarks: Dr P.T. Thomas, Chairman of Organising Committee
09:45 Opening Speech: Dr Ramli Zainal Senior Director, Pharmaceutical Services Programme, Ministry of Health, Malaysia
10.00 Group Photo & Tea Break
11:00 Introduction – Overview of APEC Roadmap, Supply Chain Security Toolkit and Centers of Excellence: Lane Christensen (US FDA)
Session I: Good Distribution Practice (GDP)
11:30 Introduction and Overview of Toolkit GDP. Why GDP is important and highlight of the toolkit: Tony Orme (MHRA)
12:00 Lunch
13:30 Framework for GDP: Murali Sambasivan (Taylor’s University)
14:15 Regulatory Trends that are shaping the GDP landscape Brett Marshall (Zuellig Pharma)
15:00 Challenges/Strategies in Cold Chain – Case studies Brett Marshall (Zuellig Pharma)
15:30 Operations (Industry Perspectives) – Current challenges and findings Strategies/Best Practices to ensure Supply Chain integrity: Chloe Lee (Roche)
16:00 Tea Break
16:30 Malaysia’s Experience and Challenges in implementing GDP: Nor Hafizah binti Mohd Potri (National Pharmaceutical Regulatory Agency, Malaysia)
17:00 Closing Day 1
17:15 Bus pick-up and transport back to Sunway Clio Hotel
Day 2: Thursday, September 26th, 2019
08:30 Bus pick-up from Sunway Clio Hotel and transport to Taylor’s University
09:00 Housekeeping Announcements
Session II: Track and Trace
09:15 Overview and what’s included in the Toolkit for Track and Trace Senthil Rajaratnam (Eli Lilly)
09:30 The Importance of Using Global Standards for Track and Trace Marcel de Grutter (Abbott)
10:00 Traceability Policy Requirements – Key Drivers for developing traceability regulation – Best Practices for traceability requirements: Senthil Rajaratnam (Eli Lilly)
10:30 Tea Break
10:45 Global Regulatory Evolution for Product Serialization and Traceability: Leandro Oliveira (J&J)
11:15 Serialization and traceability as well as challenges and impact on GDP: CK Lam (Pfizer)
11.45 Track & Trace: Malaysia’s Perspectives: Mohd Azuwan Mohd Zubir (Ministry of Health Malaysia)
12.15 Case Study/Demonstration of Track and Trace Technology Senthil Rajaratnam (Eli Lilly)
13:00 Lunch
Session III: Internet Sales
14:00 Overview of APEC Supply Chain Internet Sales Toolkit and Gap Analysis: Jeffrey Gren (ASOP Global)
14.30 Criteria for 0nline sales of Medical Products in Malaysia: Siti Mariaton Binti Abd Moksin (Ministry of Health, Malaysia)
15:00 Global Internet Pharmacy Best Practices – Lessons Learned from Building Relationships and Private Sector Voluntary Actions: Jeffrey Gren (ASOP Global)
15:20 Tea Break
15:30 Combating Illegal Internet Sales of Medical Products – Strategies used in Malaysia: Norlida Binti Abdul Rahman (Ministry of Health, Malaysia)
16:00 Existing Industry Initiatives to Promote Safe Medicines: Ramesh Raj (Pharmaceutical Security Institute)
16:30 Sharing of HSA’s experience in managing online sales of health products: Beatrice Poh, (Health Sciences Authority (HSA), Singapore)
17.00 Panel Discussion and Presentations – Sharing of Best Practices to Combat Illegal Internet Drug Sales from APEC Economies (Singapore, Thailand, Indonesia) Jeffrey Gren (ASOP Global)
17.30 Question and Answer Session and Open Discussion:Jeffrey Gren (ASOP Global)
17:45 Closing Day 2
18.00 Dinner hosted by AHC and Taylor’s University at Taylor’s University
20.00 Bus pick-up and transport back to Sunway Clio Hotel
Day 3: Friday, September 27th, 2019
Session IV:
08.30 Bus pick-up from Sunway Clio Hotel and transport to Taylor’s University
09:00 Site Visit to Zuellig Pharma, a leading multinational pharmaceutical distributor – Observation of “GDP in action”
12:15 Lunch (at Zuellig Pharma)
14:00 Case study exercises (one case study each for GDP, T &T and Internet Sales) – Break into small groups, Sharing real-life experiences and challenges some economies are facing in GDP, Track and Trace and Internet Sales – Challenges and concerns in implementing best practices/ toolkit: P.T. Thomas
15:00 Closing Speech: Fabian Bigar, Undersecretary, Policy and International Relations Division, Ministry of Health Malaysia
15:30 Tea and Departure
16.30 Bus pick-up and transport back to Sunway Clio Hotel