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Supply Chain Integrity (SOMⅠ)

APEC Life Sciences Innovation Forum (LSIF) Training Program on Medical Product Integrity and Supply Chain Security

Good Distribution Practices, Product Security, and Establishment of Global Single Point of Contact Systems
January 26-29, 2015 Clark (Angeles City), the Philippines
APEC Life Sciences Innovation Forum (LSIF) Training Program on Medical Product Integrity and Supply Chain Security : Time, Topics, Speaker

Time

Topics

Speaker

Day 1: Monday, January 26
09:00 - 09:10 Opening and Welcome remarks The Philippines (Host)
APEC Harmonization Center
09:10 - 09:15 Introduction of APEC LSIF Training Program Mark Paxton (U.S. FDA)
Training I: Product Security
09:15 - 09:45 Introduction to Product Security Mark Paxton (U.S. FDA)
Brian Johnson (Pfizer)
09:45 - 10:30 Supply Chain Security Management System Tim Valko (Amgen)
10:30 - 10:50 Break
10:50 - 11:35 Incident Management Brian Johnson (Pfizer)
11:35 - 12:20 Cargo Theft Risks and Mitigation Strategies Tim Valko (Amgen)
12:20 - 13:30 Lunch - Review the TCM CBT
13:30 - 14:15 Illegal Diversion Scott Kammer (Takeda)
14:15 - 15:00 Threats and Monitoring Scott Kammer (Takeda)
15:00 - 15:20 Break
15:20 - 16:05 Upstream Supply Chain Security Brian Johnson (Pfizer)
16:05 - 17:50 Audits and Assessments of LSP’s Scott Kammer (Takeda)
17:50 Closing Day 1 Mark Paxton (U.S. FDA)
Day 2: Tuesday, January 27
9:00 - 9:45 Rx360 Security Supply Chain Maturity Model (SCSMM) Application David Ulrich (Abbvie)
9:45 - 10:30 SCS Program Panel - Company Experiences Tim Valko (Amgen)
Scott Kammer (Takeda)
Brian Johnson (Pfizer)
David Ulrich (Abbvie)
10:30- 10:45 Bridge to Good Distribution Practices (GDP)
Closing of Product Security Training
David Ulrich (Abbvie)
Mark Paxton (U.S. FDA)
10:45 - 11:00 Break
Training II: Good Distribution Practices
11:00 - 12:00 Good Distribution Practices / Good Supply Chain Practices (GDP / GSP)
- Global Regulation Review
- GDP Regulatory Matrix
- Standard Policy Development
Review one module (as a group) of the GDP CBT 101
David Ulrich (Abbvie)
12:00 - 13:00 Lunch - Review the TCM CBT
13:00 - 13:45 Temperature Control Management (TCM)
- ICH stability testing vs. storage label claim
   o Controlled Room Temperature (CRT) Label claim issues
   o Best CRT Label
- Stability data vs. supply chain temp excursions (Exception management)
- Temperature cycle studies → Stability Budget
Adding sections to the filing/MA
David Ulrich (Abbvie)
13:45 - 14:30 Temperature Control Management (TCM)
- Lane qualification
Patient level temperature control
Claude Jolicoeur (McKesson Canada)
14:30 - 15:15 Lane Qualification
  - Ambient profiles - do you need them
  - Passive Shipper Qualification
  - Active Shipper Qualification

Review multiple lane PQ
  - Actual Exception reports - product disposition
  - Wholesaler, 3PL, transportation,
  - Pharmacy/Hospital/Clinic and patient
Claude Jolicoeur (McKesson Canada)
15:15 - 15:30 Break
15:30 - 16:15 GDP audit guideline
- APIC, IPEC, Rx360
David Ulrich (Abbvie)
16:15 - 17:00 EU, MHRA and IMB audit observation review David Ulrich (Abbvie)
17:00 - 18:00 General GDPs - SOP review
  - Cycle counts and Inventory control
  - Reverse logistics and Restock Program
  - Destruction (MDO)
QA holds and Quarantine
Dan O’Shaughnessy (Pfizer)
18:00 Closing of GDP Training Mark Paxton (US FDA)
Day 3: Wednesday, January 28
Training III: Single Point of Contact System (SPOCs) Training
Session I - Risks posed by spurious, substandard, falsified, fraudulent, counterfeit (SSFFC)
                    medical products in the APEC region - what measures and cooperation
                    approaches with a focus on falsified (counterfeit) medical products do exist?
09:10 - 09:30 Opening

Introduction
Overview of Course: Objectives and APEC RHSC past and future activities related to SSFFC medicines

Risks posed by spurious, substandard, falsified, falsely labelled, counterfeit (SSFFC) medical products, medical products with a focus on falsified (counterfeit) medical products
Atty. Allan Gepty (IPOPhil)
Jeffrey Gren (ASOP)

Lynda Scammell (MHRA)
09:30 - 10:00 Panel Discussion: APEC economies’ situation and approaches to tackle prevention and combat of SSFFC medical products with a focus on falsified (counterfeit) medical products Discussion moderators:

Jesusa Joyce N. Cirunay
(FDA Philippines)
Mokhtar Bin Abdullah
(MOH Malaysia)
Sergey Glagolev
(Roszrdarnvadzor)
10:00 - 10:20 The legal medical products production and supply chain: medical products types and basic regulatory approaches to prevent loopholes for contamination with falsified (counterfeit) medical products Sergey Glagolev
(Roszrdarnvadzor)
Mokhtar Bin Abdullah (MOH Malaysia)
10:20 - 10:45 Illegal sources of falsified (counterfeit) medical products (“black market”): Detection of signals by Police and Customs; Investigation/ operational management of cases

Discussion
Christian Tournie (OCLAESP)
Winfred Kooij (Dutch Customs Service)
10:45 - 11:15 Coffee break
Breakout
Session
11:15 - 12:15
Practical Exercise 1 - What is a signal for health/police and customs authorities and what are signal transmission pathways?
The participants will constitute three groups split into disciplines (drug regulatory, police and customs authorities) and break out in 3 groups. Moderators will facilitate the discussion of selected questions and rapporteurs will take notes for the group report.
Each group determines 5 criteria for administrative offence or suspected criminal case: what follows from there for the involvement of the competent authorities.
Each group determines 5 criteria for the definition of a signal and 5 key steps as regards signal transmission and intersections for cooperation.
- Introduction and presentation of the practical case scenario: Lynda Scammell
- Moderators and rapporteurs: Christian Tournie and Mokhtar Bin Abdullah; Lynda Scammell and Sergey Glagolev; Winfred Kooij Moderators and rapporteurs: Christian Tournie and Mokhtar Bin Abdullah;
Lynda Scammell and Sergey Glagolev; Winfred Kooij and Joyce Cirunay
12:15 - 13:00 Report from each Group & Discussion
13:00 - 14:00 Lunch Break
Session II - Improving the Cooperation between Single Points of Contact (SPOC) within Health,
                     Police, Customs authorities to fight counterfeit/falsified medical products to
                     protect public health - where do we have to watch out - what do we need?
14:00 - 14:45 The APEC model for a network among SPOCs to fight counterfeit/falsified medical products & to protect public health: goals, measures, tools and definitions

Discussion
Jeffrey Gren
(ASOP)
Francois-Xavier LERY
(EDQM, Council of Europe)
Session III - Multidisciplinary & multisectorial cooperation among the competent authorities to
                   investigate/ manage criminal cases of falsified (counterfeit) medical products
                   and protect public health - how does it work practically?
14:45 - 15:00 Example (1): National SPOCs Network: Police, Customs, and DRA points of view Lynda Scammell (MHRA)
Christian Tournie (OCLAESP)
Winfred Kooij
(Dutch Customs Service)
15:00 - 15:30 Example (2): Situation of cooperation among competent authorities in the APEC region Jesusa Joyce N. Cirunay
(FDA Philippines)
Mokhtar Bin Abdullah
(MOH Malaysia)
Sergey Glagolev
(Roszrdarnvadzor)
15:30 - 16:00 Coffee break
16:00 - 16:15 Example (3): Cooperation between the competent authorities and industry and health professionals: risk management and prevention Samson Chiu (PSI, Asia)
Maria Minerva Calimag
(PMA, Philippines)
Breakout Session
16:15 - 17:00
Practical Exercise 2 - You have been asked to set up a cooperation system among the competent authorities of your country (health, and enforcement authorities such as Police and customs) - How do you start?

How can SPOCs support each other in the operational management of cases and benefit from synergies? (Practical examples from closed cases)

The participants will constitute three mixed groups (drug regulatory, police and customs authorities) and break out in 3 groups. Moderators will facilitate the discussion of selected questions and rapporteurs will take notes for the group report.
Each group identifies 5 recommendations for establishing a national SPOCs network overcoming possible obstacles.
Each group determines 5 recommendations for a more effective cooperation as regards the operational management of cases.
- Introduction and presentation of the practical case scenario: Lynda Scammell
- Moderators and rapporteurs: Christian Tournie and Mokhtar Bin Abdullah; Lynda Scammell and Sergey Glagolev; Winfred Kooij Joyce Cirunay
17:00 - 17:30 Report from each Group & Discussion
17:30 Colsing Day 3
Day 4: Thursday, January 29
09:00 - 09:15 Summary of Day One Jeffrey Gren (ASOP)
Session IV - Multidisciplinary & multisectorial cooperation among authorities to fight falsified
                      (counterfeit) medical products and protect public health -Which legal basis
                      can support the cooperation? Which skills, tools and knowledge are required
                      for SPOCs to cooperate effectively?
09:15 - 09:30 How to support the cooperation among states to fight and prevent falsified (counterfeit) medical products at global level: MEDICRIME Convention
Discussion
Christian Tournie
(OCLAESP)
09:30 - 10:00 Identification of SSFFC medical products on the Internet Lynda Scammell (MHRA)
Mokhtar Bin Abdullah
(MOH Malaysia)
Jeffrey Gren (ASOP)
10:00 - 10:30 Practical tools and approaches for SPOCs Francois-Xavier LERY
(EDQM, Council of Europe)
Shaba Mohammed
(NAFDAC)
10:30 - 11:00 Coffee break
Breakout
Session
11:00 - 12:00
Practical Exercise 3 - How to establish practically a national SPOCs network - a practical plan for the way forward


All APEC delegations will develop together a model action plan. Moderators will facilitate the discussion of selected questions and rapporteurs will take notes for the group report.
- Moderators: Jeffrey Gren and Lynda Scammell
- Rapporteurs: Mokhtar Bin Abdullah, Sergey Glagolev and Florita D.Moraleja
12:00 - 12:30 Model action plan from each Group Lynda Scammell (MHRA)
Christian Tournie
(OCLAESP)
12:30 - 12:45 Conclusions & Evaluation of training APEC Project leads
Rapporteurs
12:45 - 12:50 Closing of SPOCs Training Emilio L. Polig, Jr. (FDA Philippines)
Francois-Xavier Lery
(EDQM, Council of Europe)
12:50 - 13:30 Lunch
2nd Stocktaking Meeting of the Roadmap for Global Medical Product Quality and Supply Chain Integrity
13:30 - 14:15 Remarks and Panel Introduction: SOM III Planning Mark Paxton (U.S. FDA)
14:15 - 14:20 Final Closing Remarks Mark Paxton (U.S. FDA)
10:05 - 10:35 Mark Paxton (U.S. FDA)