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Supply Chain Integrity (SOMⅠ)

Mark Paxton 

  • Mark Paxton Regulatory Counsel, Office of Compliance, CDER, U.S. FDA
    • Day 1 > Workshop Opening
      • Intoduction of APEC LSIF Training Program
      • Closing Day 1
    • Day 2 > Bridge to Good Distribution Practices (GDP)
      • Closing of Product Security Training
      • Closing of GDP Training
    • Day 3 > 2nd Stocktaking Meeting of the Roadmap for Global Medical Product Quality and Supply Chain Integrity
      • Remarks and Panel Introduction: SOM III Planning
      • Final Closing Remarks

Brian Johnson 

  • Brian Johnson Senior Director, Supply Chain Security, Pfizer
    • Day 1 > Training I: Product Security
      • Introduction to Product Security
      • Incident Management
      • Upstream Supply Chain Security
    • Day 2 > Training I: Product Security
      • SCS Program Panel - Company Experiences

Tim Valko 

  • Tim Valko Executive Director, US Supply Chain, Amgen
    • Day1 > Training I: Product Security
      • Supply Chain Security Management System
      • Cargo Theft Risks and Mitigation Strategies
    • Day 2 > Training I: Product Security
      • SCS Program Panel - Company Experiences

Scott Kammer 

  • Scott Kammer Director, Global Product Security, Takeda
    • Day 1 > Training I: Product Security
      • Illegal Diversion
      • Threats and Monitoring
      • Audits and Assessments of LSP’s
    • Day 2 > Training I: Product Security
      • SCS Program Panel - Company Experiences

David Ulrich 

  • David Ulrich QA Director, Supply Chain Compliance, Abbive
    • Day 2 > Training I: Product Security
      • Rx360 Security Supply Chain Maturity Model (SCSMM) Application
      • SCS Program Panel - Company Experiences
      • Bridge to Good Distribution Practices (GDP)
    • Day 2 > Training II: Good Distribution Practices
      • Good Distribution Practices/Good Supply Chain Practices (GDP/GSP) Review one module (as a group) of the GDP CBT 101
      • Temperature Control Management (TCM), Label Claim Issues, Excursions (Exception managment), Adding section to the filing/MA
      • GDP audit guideline
      • EU, MHRA, and IMB audit observation review

Claude Jolicoeur 

  • Claude Jolicoeur Director Regulatory Affairs, Corporate GMP Officer, Legal Services, Compliance and GMP, McKesson Canada
    • Day 2 > Training II: Good Distribution Practices
      • Temperature Control Management (TCM), Patient level temperature control
      • Lane Qualification, Review multiple lane PQ, Disposition

Dan O’Shaughnessy 

  • Dan O’Shaughnessy Sr. Director Supply Chain QO, Department of Quality, Pfizer
    • Day 2 > Training II: Good Distribution Practices
      • General GDPs - SOP review, QA holds and Quarantine

Jeffrey Gren 

  • Jeffrey Gren Board Member, Alliance for Safe Online Pharmacies
    • Day 3 > Training III: Single Point of Contact System
      • Opening & Introduction
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session II
      • The APEC model for a network among SPOCs to fight counterfeit/falsified medical products & to protect public health: goals, measures, tools and definitions
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Identification of SSFFC medical product on the Internet
      • Breakout Session: Practical Exercise 3 (Moderator)
    • Day 4 > Training III: Single Point of Contact System
      • Summary of Day One

Mokhtar Bin Abdullah 

  • Mokhtar Bin Abdullah Senior Principle Assistant Director, Pharmaceutical Service Divisions, Ministry of Health Malaysia
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Panel Discussion: APEC economies’ situation and approaches to tackle prevention andcombat of SSFFC medical products with a focus on falsified (counterfeit) medical products
      • The legal medical products production and supply chain
      • Breakout Session: Practical Excercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (2): Situation of cooperation among competent authorities in the APEC region
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Identification of SSFFC medical products on the Internet
      • Breakout Session: Practical Exercise 3 (Moderator)

Lynda Scammell 

  • Lynda Scammell Senior-Policy Manager, Department of Health, MHRA (Medicines and Healthcare products Regulatory Agency)
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Introduction
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Identification of SSFFC medical products on the Internet
      • Breakout Session: Practical Exercise 3 (Modertor)

Francois-Xavier Lery 

  • Francois-Xavier Lery Head of Section, European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session II
      • The APEC model for a network among SPOCs to fight counterfeit/falsified medical products & to protect public health: goals, measures, tools and definitions
    • Day 3 > Training III: Session III: Single Point of Contact System > Session III
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Practical tools and approaches for SPOCs
      • Breakout Session: Practical Excercise 3 (Moderator)
      • Closing of SPOCs Training

Shaba Mohammed 

  • Shaba Mohammed Assistant Director, Investigations and Enforcement, NAFDAC
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Practical tools and approaches for SPOCs

Winfred Kooij 

  • Winfred Kooij Senior Customs Officer/Project Manager, Customs Groningen, Customs the Netherlands
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Illegal sources of falsified (counterfeit) medical products (“black market”)
      • Breakout SessionL Practical Excercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (1): National SPOCs Network: Police, Customs, and DRA points of view
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • Breakout Session: Practical Exercise 3 (Moderator)

Christian Tournie 

  • Christian Tournie Head, Intelligence and International Cooperation Department, OCLAESP (French Central Office Environmental and Public Health Crime)
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Illegal sources of falsified (counterfeit) medical products (“black market”)
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (1): National SPOCs Network: Police, Customs, and DRA points of view
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV
      • How to support the cooperation among states to fight and prevent falsified (counterfeit) medical products at global level: MEDICRIME Convention
      • Breakout Session: Practical Exercise 3 (Moderator)

Sergey Glagolev 

  • Sergey Glagolev Chief, Department of monitoring of Safety and effectiveness of medical products, Federal Service for Supoervision in Healthcare (Roszrdarnvadzor)
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Panel Discussion: APEC economies’ situation and approaches to tackle prevention and combat of SSFFC medical products with a focus on falsified (counterfeit) medical products
      • The legal medical products production and supply chain
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (2): Situation of cooperation among competent authorities in the APEC region
      • Breakout Session: Practical Exercise 2 (Moderator)

Maria Minerva Calimag 

  • Maria Minerva Calimag Professor, Graduate School, University of Santo Tomas
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (3): Cooperation between the competent authorities and industry and health professionals: risk management and prevention

Samson Chiu 

  • Samson Chiu Director, Asia-Pacific Region, Pharmaceutical Security Institute
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (3): Cooperation between the competent authorities and industry and health professionals: risk management and prevention

Jesusa Joyce N. Cirunay 

  • Jesusa Joyce N. Cirunay Food-Drug Regulation Officer V, FDA Philippines
    • Day 3 > Training III: Single Point of Contact System > Session I
      • Panel Discussion: APEC economies’ situation and approaches to tackle prevention andcombat of SSFFC medical products with a focus on falsified (counterfeit) medical products
      • Breakout Session: Practical Exercise 1 (Moderator)
    • Day 3 > Training III: Single Point of Contact System > Session III
      • Example (2): Situation of cooperation among competent authorities in the APEC region
      • Breakout Session: Practical Exercise 2 (Moderator)
    • Day 4 > Training III: Single Point of Contact System > Session IV > Breakout Session
      • Breakout Session: Practical Exercise 3 (Moderator)