Programme
7:00 – 8:30
Registration and welcome coffee
7:15 – 8:15
A starter session about GS1 standards
Introduction to global standards for Identify, Capture and Share
- Mr. Salil Joshi, Senior Director, Industry Development - Healthcare, GS1 US (confirmed)
- Ms. Beth Gibson, Senior Director, Industry Development - Medical Devices, GS1 US (confirmed)
- Mr. Peter Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals, GS1 US (confirmed)
- Ms. Adrian Bailey, Manager Healthcare, GS1 US
8:30 – 12:35
Opening Plenary Session – Hospitals, doctors and clinicians
A session about GS1 standards in hospitals – hear wide ranging perspectives and experiences from varying experts from across the globe
8:30 – 8:50
Opening remarks and welcome to the conference
- Ms. Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office (confirmed)
- Mr. Miguel A. Lopera, President and CEO, GS1 Global Office (confirmed)
- Mr. Bob Carpenter, CEO, GS1 US (confirmed)
8:50 – 10:20
Panel – Patient safety beyond borders
Chaired by Prof. Dr. Terence Stephenson, Chair, General Medical Council, UK (confirmed)
- Dr. Anne Snowdon, Chair, World Health Innovation Network, Scientific Director & CEO, SCAN Health, Canada (confirmed)
- Mr. David Berridge, Deputy Medical Director, Leeds Teaching Hospitals NHS Trust, UK (confirmed)
- Ms. Dr. Juliette Hommes, MD, University Medical Center of Maastricht (MUMC), The Netherlands (confirmed)
10:20 - 10:50
Coffee break
10:50 - 12:20
Panel – Healthcare professionals – different viewpoints, one goal
Chaired by Mr. Keith Jones, Clinical Director of Surgery, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Iain Davidson, Chief Pharmacist & CCIO, Royal Cornwall Hospitals NHS Trust, UK (confirmed)
- Ms. Lorna Wilkinson, Director of Nursing, Salisbury NHS Foundation Trust, UK (confirmed)
- Mr. Nick Thomas, Deputy CEO, Plymouth Hospitals NHS Trust, UK (confirmed)
12:20 - 12:25
Introduction to conference charity
GS1 Healthcare supports a local charity with 5 USD for every feedback form received.
The Josie King Foundation (confirmed)
http://josieking.org/
12:25 - 12:35
Introduction of afternoon sessions and the poster reception
12:35 - 13:30
Networking lunch
In parallel: Hospital “Surgery” lunch – speakers from the morning each host a table
13:30 - 15:00
Two parallel streams - Participants can choose which stream to attend.
Panel – Data for better care – hospital operational efficiency
Chaired by Mr. Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland (confirmed)
- Mr. Keith Jones, Clinical Director of Surgery, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Kevin Downs, Director Finance, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Wilfried Winzer, Director, University hospital Dresden, Germany (confirmed)
Public Policy: Pharmaceuticals
Regulatory requirements and initiatives from around the world related to pharmaceuticals – normally a closed group; it is only open for this session.
Moderators:
- Ms. Cyndi Poetker, Director Global Standards and Traceability Global Standards and Serialization, Abbott (confirmed)
- Ms. Géraldine Lissalde-Bonnet, Public Policy Director, GS1 Global Office (confirmed)
15:00 - 15:30
Coffee break
15:30 - 17:00
Two parallel streams - Participants can choose which stream they wish to attend.
Panel – Cost savings through standards
Chaired by Mr. Justin Bitter Ph.D, Business manager, Bernhoven Hospital, the Netherlands (confirmed)
- Mr. Jitendra Prasad, Chief Program Officer for contracting, procurement and supply chain management, Alberta Health Service, Canada (confirmed)
- Ms. Cynthia Shumway, Director, Supply Chain Business Applications, Intermountain Healthcare, U.S. (confirmed)
- Mr. Matthew Mentel, Executive Director - Integrated Performance Solutions, Mercy, U.S. (confirmed)
- Ms. Betty Jo Rocchio, Vice President, Perioperative Services, Mercy, U.S. (confirmed)
Panel - UDI Implementation reality - Data Quality
Chaired by Mr. Volker Zeinar, Global Coordinator Auto-ID Affairs, B. Braun. Germany (confirmed)
One of the most important aspects of any UDI regulation is achieving high data quality at the source and mainlining throughout the information lifecycle process.
When high quality data is achieved hospitals can use it in their internal processes and including Electronic Health Records. Join this session and learn from experts who are achieving high quality data and hospitals who are integrating it into their processes.
- Ms. Terrie Reed, U.S. FDA, Senior Advisor UDI Adoption, U.S. Food and Drug Administration (confirmed)
- Mr. Joseph Costagliola, Project Manager, Master Data Management, B. Braun Medical, U.S. (confirmed)
- Mr. James Phillips, Consulting Manager, the Office of Data Standards & Interoperability, Franciscan Missionaries Of Our Lady Health System, U.S. (confirmed)
- Mr. Kevin Capatch, Director Supply Chain Technology & Process Engineering, Geisinger Health Systems, U.S. (confirmed)
17:00 - 18:00
Poster reception
Discover the latest GS1 Healthcare implementations and initiatives developed by GS1 member organisations – vote for the best poster
17:00 - 19:00
International Government Healthcare Supply Chain ThinkTank (Invitation only)
Open to international government healthcare organisations – discussions will be held under the Chatham House Rule
8:30 - 13:00
Plenary session – Pharmaceutical traceability from manufacturer to patient
Traceability is an ubiquitous requirement in Healthcare – to improve patient safety through visibility in many business processes
8:30 – 8:50
Standards in humanitarian work
- Mr. Tom Woods, chairman of the Global Steering Committee for Quality Assurance, World Bank, U.S. (confirmed)
- Dr. Ramy Guirguis, Senior Information Technology Advisor, USAID, U.S. (confirmed)
8:30 – 9:00
Welcome coffee
8:50 – 9:10
Early learnings from policy work on implementation of global standards
Mr. Yehulu Denekew, Director General, Food, Medicine, Health Care Administration and Control Authority of Ethiopia (FMHACA) (confirmed)
9:10 – 9:35
US FDA Drug Supply Chain Security Act (DSCSA)
Ms. Connie T. Jung, RPh, PhD, Senior Advisor for Policy, Office of Drug Security, Integrity, and Response (ODSIR), Center for Drug Evaluation and Research, Office of Compliance, U.S. Food and Drug Administration (invited)
9:35 - 10:50
Panel – DSCSA Implementation
Chaired by Mr. Scott Mooney, Vice President, Distribution Operations, McKesson (confirmed)
- Mr. Chris Reed, Lead, Product Serialization and Traceability, Johnson & Johnson, U.S. (confirmed)
- Mr. Jeff Denton, Sr. Director, Global Secure Supply Chain, AmerisourceBergen, U.S. (confirmed)
- Mr. Thomas McHugh, Sr. Strategist SC Systems, CVS Health (confirmed)
10:50 - 11:30
Coffee break
11:30 - 11:55
EU Falsified Medicines Directive
Mr. Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson, U.S. (confirmed)
11:55 – 12:15
Pharmaceutical traceability in Brazil
Ms. Bianca Zimon Giacomini Ribeiro, Deputy Chief Adviser for International Affairs, National Agency of Sanitary Surveillance (Anvisa), Brazil (confirmed)
12:15 – 12:40
Achieving single unit pharmaceutical traceability
Mr. Tjalling van der Schors, Pharm.D., Hospital Pharmacist, President NVZA, Director of Pharmacy, WestfriesGasthuis, Netherlands (confirmed)
12:40 – 13:00
Identification of Medicinal Products (IDMP)
Ta-Jen (TJ) Chen, Project Management Officer, FDA/CDER/ Office of Strategic Programs, U.S. Food and Drug Administration (confirmed)
13:00 – 14:00
General networking lunch
In parallel: Hospital “Surgery” lunch – speakers from day one each host a table
14:00 – 15:30
Three parallel streams - Participants can choose which stream to attend.
Implementation of GS1 standards in clinical trials processes
Chaired by Dr. Greg Koski, PhD, MD, Chairman of the Board of Directors, Co-Founder & President, CEO, ACRES - Alliance for Clinical Research Excellence and Safety, U.S. (confirmed)
- Mr. Hans von Steiger, PMP Group Leader, Clinical Supply Chain Management, Pfizer, U.S. (confirmed)
- Ms. Sylvia Bartel, VP Pharmacy, Dana-Farber Cancer Institute, U.S. (confirmed)
- Mr. Sylvain Alberola, Head, Clinical Supply Chain Industrial Development, Sanofi (confirmed)
The surge for data and information
Chaired by Mr. David Brooks, Director of Engineering, Strategic Project Management, Medtronic, U.S. (invited)
- Mr. Charlie Kim, President and CEO, 121nexus, U.S. (confirmed)
- Mr. Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland (confirmed)
- Ms Tatjana Pathare, Artworks and Regulations Specialist within the Serialisation Project, F. Hoffmann La Roche (confirmed)
- Mr. Stefan Artlich, Director, Senior Project Manager 'Track&Trace', Bayer, Germany (invited)
Public Policy: Medical Devices
Regulatory requirements and initiatives from around the world related to medical devices – normally a closed group; it is only open for this session.
Moderators:
- Ms. Géraldine Lissalde-Bonnet, Public Policy Director, GS1 Global Office (confirmed)
- Ms. Jackie Elkin, Global Process Owner - Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
15:30 - 16:00
Coffee break
16:00 - 17:30
Two parallel streams - Participants can choose which stream to attend.
Panel - Pharmaceutical Traceability – learnings from around the world
Different manufacturers will present their respective approach to traceability, leveraging a combination best practices and lessons learned of implementation of regulatory and tender requirements for drug serialisation using GS1 standards. Join this session and participate in a discussion with experts who share their experiences and offer advice for traceability implementation.
Chaired by Mr. Senthil Rajaratnam, Affiliate Serialization Account Manager, Eli Lilly and Company, U.S. (confirmed)
- Mr. Lloyd Mager, Global Traceability Lead, AbbVie, U.S. (confirmed)
- Mr. Pascal Aulagnet, Senior Manager, Global Serialization - EMEA Client Partner, Pfizer, France (confirmed)
- Mr. Stefan Artlich, Director, Track & Trace, Bayer, Germany (confirmed)
Panel - UDI – AIDC Implementation experiences
Looking for more insight into the steps involved in the implementation of identification and marking (AIDC) of medical devices for the U.S. FDA UDI rule and other global UDI initiatives? The past few years have seen many implementation initiatives around the globe meant to meet the needs of UDI. Join this session to hear about the challenges and successes, and learn from our panellists as they share their practical experiences.
Chaired by Ms. Jackie Elkin, Global Process Owner Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
- Mr. John Terwilliger, GS1 Senior Consultant, Global Standards & Serialization Office, Abbott, U.S. (confirmed)
- Mr. Mark Hoyle, Technical Director, UDI, Commercial Regulatory Affairs, Teleflex, Ireland (confirmed)
- Mr. Georg Keller, Manager Regulatory Affairs, Labeling Coordinator, B.Braun / Aesculap AG, Germany (confirmed)
19:00 - 22:00
Networking event at John G. Shedd Aquarium hosted by GS1 US
Transportation will be provided beginning at 18:30 in the main lobby area of the hotel. Return shuttles from the Aquarium will be available as early as 8pm and will run on a loop with the last shuttle leaving at 22:15.
06:45 - 08:45
Site Visits - Visit to Macy's Downtown Chicago
A morning tour before the store opens to see how RFID is used.
Max. group size: 20 attendees (split into two groups)
Meeting point: hotel lobby (to walk to the store)
A Continental breakfast is available afterwards at the conference venue
8:30 – 9:00
Welcome coffee
9:00 – 9:25
UDI in the US
Ms. Terrie Reed, Senior Advisor for UDI Adoption, U.S. Food and Drug Administration (confirmed)
9:00 - 10:30
Plenary session – UDI
UDI aims to establish a single device identification system that is consistent, unambiguous and globally standardised. The session provides an overview of the status on UDI across the world and informs on other initiatives regarding track & trace for medical devices.
9:25 – 9:50
UDI in Europe
Mr. Salvatore Scalzo, Policy and Legal Officer, Medical Devices, DG GROW, European Commission (confirmed)
9:50 – 10:10
UDI in Turkey
Dr. Yalçın Soysal, Head of Department, Department of Medical Devices Registration and Coordination, Ministry of Health, Turkey (confirmed)
10:10-10:30
Global Medical Technology Alliance discussing International Medical Device Regulators Forum (IMDRF)
Ms. Jackie Elkin, Global Process Owner Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
10:30-11:00
Coffee break
11:00 - 13:00
Plenary session – Imagine one world, one standard, one vision: Improving Patient Safety
11:00 - 11:10
Healthcare Provider Advisory Council (HPAC) Award
The GS1 HPAC provides two awards for:
- an individual who has contributed extensively to furthering GS1 Healthcare's work efforts over the years;
- a provider organisation that has implemented GS1 Standards for at least one process in their organisation.
11:10 – 11:30
Presentation of winner 1 of HPAC Award
11:10 - 11:30
Presentation of winner 2 of HPAC Award
11:50 – 12:10
Implementation of GS1 standards at Centro Medico Imbanaco
Mr. José Luis Sabogal, IT Manager, Centro Medico Imbanaco, Colombia (confirmed)
12:10 – 12:15
Invitation to next conference in Bogota, Colombia
Mr. Rafael Florez, CEO, GS1 Colombia (confirmed)
12:15 – 12:55
Inspirational speaker
Ms. Sorrel King, Founder, The Josie King Foundation, U.S. (confirmed)
12:55 – 13:00
Closing remark
GS1 Healthcare Tri-Chairs (confirmed)
13:30 - 18:00
Site Visits - Two parallel Options
Option 1. Visit to the Zebra Experience Centre
Visit to the Zebra Experience Centre to see GS1 standards applied with some of the latest AIDC technologies in a real-life environment.
Max. group size: 50 attendees
Meeting point: hotel lobby.
Time: 13:30 - 17:30 (Expected return at the hotel)
"To-go" lunch boxes will be provided
Option 2. Visit to the McKesson, DC
Tour to the McKesson regional Distribution Center to see this production, together with sophisticated product picking technologies, in action.
Max. group size: 60 attendees (split in two groups)
Meeting point: hotel lobby.
Time:
Group 1: 13:30 – 17:00 (Expected return at the hotel)
Group 2: 14:30 – 18:00 (Expected return at the hotel)
"To-go" lunch boxes will be provided.
9:30 – 12:30
Visit to the Zebra Experience Centre (MO only)
A special MO visit to the Zebra Experience Center to see how GS1 standards are applied with the latest AIDC technologies in a real-life environment.
Meeting point: hotel lobby.
Please take care of your breakfast before the tour departs.
TUESDAY
7:00 – 8:30
Registration and welcome coffee
7:15 – 8:15
A starter session about GS1 standards
Introduction to global standards for Identify, Capture and Share
- Mr. Salil Joshi, Senior Director, Industry Development - Healthcare, GS1 US (confirmed)
- Ms. Beth Gibson, Senior Director, Industry Development - Medical Devices, GS1 US (confirmed)
- Mr. Peter Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals, GS1 US (confirmed)
- Ms. Adrian Bailey, Manager Healthcare, GS1 US
8:30 – 12:35
Opening Plenary Session – Hospitals, doctors and clinicians
A session about GS1 standards in hospitals – hear wide ranging perspectives and experiences from varying experts from across the globe
8:30 – 8:50
Opening remarks and welcome to the conference
- Ms. Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office (confirmed)
- Mr. Miguel A. Lopera, President and CEO, GS1 Global Office (confirmed)
- Mr. Bob Carpenter, CEO, GS1 US (confirmed)
8:50 – 10:20
Panel – Patient safety beyond borders
Chaired by Prof. Dr. Terence Stephenson, Chair, General Medical Council, UK (confirmed)
- Dr. Anne Snowdon, Chair, World Health Innovation Network, Scientific Director & CEO, SCAN Health, Canada (confirmed)
- Mr. David Berridge, Deputy Medical Director, Leeds Teaching Hospitals NHS Trust, UK (confirmed)
- Ms. Dr. Juliette Hommes, MD, University Medical Center of Maastricht (MUMC), The Netherlands (confirmed)
10:20 - 10:50
Coffee break
10:50 - 12:20
Panel – Healthcare professionals – different viewpoints, one goal
Chaired by Mr. Keith Jones, Clinical Director of Surgery, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Iain Davidson, Chief Pharmacist & CCIO, Royal Cornwall Hospitals NHS Trust, UK (confirmed)
- Ms. Lorna Wilkinson, Director of Nursing, Salisbury NHS Foundation Trust, UK (confirmed)
- Mr. Nick Thomas, Deputy CEO, Plymouth Hospitals NHS Trust, UK (confirmed)
12:20 - 12:25
Introduction to conference charity
GS1 Healthcare supports a local charity with 5 USD for every feedback form received.
The Josie King Foundation (confirmed)
http://josieking.org/
12:25 - 12:35
Introduction of afternoon sessions and the poster reception
12:35 - 13:30
Networking lunch
In parallel: Hospital “Surgery” lunch – speakers from the morning each host a table
13:30 - 15:00
Two parallel streams - Participants can choose which stream to attend.
Panel – Data for better care – hospital operational efficiency
Chaired by Mr. Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland (confirmed)
- Mr. Keith Jones, Clinical Director of Surgery, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Kevin Downs, Director Finance, Derby Teaching Hospitals NHS Foundation Trust, UK (confirmed)
- Mr. Wilfried Winzer, Director, University hospital Dresden, Germany (confirmed)
Public Policy: Pharmaceuticals
Regulatory requirements and initiatives from around the world related to pharmaceuticals – normally a closed group; it is only open for this session.
Moderators:
- Ms. Cyndi Poetker, Director Global Standards and Traceability Global Standards and Serialization, Abbott (confirmed)
- Ms. Géraldine Lissalde-Bonnet, Public Policy Director, GS1 Global Office (confirmed)
15:00 - 15:30
Coffee break
15:30 - 17:00
Two parallel streams - Participants can choose which stream they wish to attend.
Panel – Cost savings through standards
Chaired by Mr. Justin Bitter Ph.D, Business manager, Bernhoven Hospital, the Netherlands (confirmed)
- Mr. Jitendra Prasad, Chief Program Officer for contracting, procurement and supply chain management, Alberta Health Service, Canada (confirmed)
- Ms. Cynthia Shumway, Director, Supply Chain Business Applications, Intermountain Healthcare, U.S. (confirmed)
- Mr. Matthew Mentel, Executive Director - Integrated Performance Solutions, Mercy, U.S. (confirmed)
- Ms. Betty Jo Rocchio, Vice President, Perioperative Services, Mercy, U.S. (confirmed)
Panel - UDI Implementation reality - Data Quality
Chaired by Mr. Volker Zeinar, Global Coordinator Auto-ID Affairs, B. Braun. Germany (confirmed)
One of the most important aspects of any UDI regulation is achieving high data quality at the source and mainlining throughout the information lifecycle process.
When high quality data is achieved hospitals can use it in their internal processes and including Electronic Health Records. Join this session and learn from experts who are achieving high quality data and hospitals who are integrating it into their processes.
- Ms. Terrie Reed, U.S. FDA, Senior Advisor UDI Adoption, U.S. Food and Drug Administration (confirmed)
- Mr. Joseph Costagliola, Project Manager, Master Data Management, B. Braun Medical, U.S. (confirmed)
- Mr. James Phillips, Consulting Manager, the Office of Data Standards & Interoperability, Franciscan Missionaries Of Our Lady Health System, U.S. (confirmed)
- Mr. Kevin Capatch, Director Supply Chain Technology & Process Engineering, Geisinger Health Systems, U.S. (confirmed)
17:00 - 18:00
Poster reception
Discover the latest GS1 Healthcare implementations and initiatives developed by GS1 member organisations – vote for the best poster
17:00 - 19:00
International Government Healthcare Supply Chain ThinkTank (Invitation only)
Open to international government healthcare organisations – discussions will be held under the Chatham House Rule
WEDNESDAY
8:30 - 13:00
Plenary session – Pharmaceutical traceability from manufacturer to patient
Traceability is an ubiquitous requirement in Healthcare – to improve patient safety through visibility in many business processes
8:30 – 8:50
Standards in humanitarian work
- Mr. Tom Woods, chairman of the Global Steering Committee for Quality Assurance, World Bank, U.S. (confirmed)
- Dr. Ramy Guirguis, Senior Information Technology Advisor, USAID, U.S. (confirmed)
8:30 – 9:00
Welcome coffee
8:50 – 9:10
Early learnings from policy work on implementation of global standards
Mr. Yehulu Denekew, Director General, Food, Medicine, Health Care Administration and Control Authority of Ethiopia (FMHACA) (confirmed)
9:10 – 9:35
US FDA Drug Supply Chain Security Act (DSCSA)
Ms. Connie T. Jung, RPh, PhD, Senior Advisor for Policy, Office of Drug Security, Integrity, and Response (ODSIR), Center for Drug Evaluation and Research, Office of Compliance, U.S. Food and Drug Administration (invited)
9:35 - 10:50
Panel – DSCSA Implementation
Chaired by Mr. Scott Mooney, Vice President, Distribution Operations, McKesson (confirmed)
- Mr. Chris Reed, Lead, Product Serialization and Traceability, Johnson & Johnson, U.S. (confirmed)
- Mr. Jeff Denton, Sr. Director, Global Secure Supply Chain, AmerisourceBergen, U.S. (confirmed)
- Mr. Thomas McHugh, Sr. Strategist SC Systems, CVS Health (confirmed)
10:50 - 11:30
Coffee break
11:30 - 11:55
EU Falsified Medicines Directive
Mr. Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson, U.S. (confirmed)
11:55 – 12:15
Pharmaceutical traceability in Brazil
Ms. Bianca Zimon Giacomini Ribeiro, Deputy Chief Adviser for International Affairs, National Agency of Sanitary Surveillance (Anvisa), Brazil (confirmed)
12:15 – 12:40
Achieving single unit pharmaceutical traceability
Mr. Tjalling van der Schors, Pharm.D., Hospital Pharmacist, President NVZA, Director of Pharmacy, WestfriesGasthuis, Netherlands (confirmed)
12:40 – 13:00
Identification of Medicinal Products (IDMP)
Ta-Jen (TJ) Chen, Project Management Officer, FDA/CDER/ Office of Strategic Programs, U.S. Food and Drug Administration (confirmed)
13:00 – 14:00
General networking lunch
In parallel: Hospital “Surgery” lunch – speakers from day one each host a table
14:00 – 15:30
Three parallel streams - Participants can choose which stream to attend.
Implementation of GS1 standards in clinical trials processes
Chaired by Dr. Greg Koski, PhD, MD, Chairman of the Board of Directors, Co-Founder & President, CEO, ACRES - Alliance for Clinical Research Excellence and Safety, U.S. (confirmed)
- Mr. Hans von Steiger, PMP Group Leader, Clinical Supply Chain Management, Pfizer, U.S. (confirmed)
- Ms. Sylvia Bartel, VP Pharmacy, Dana-Farber Cancer Institute, U.S. (confirmed)
- Mr. Sylvain Alberola, Head, Clinical Supply Chain Industrial Development, Sanofi (confirmed)
The surge for data and information
Chaired by Mr. David Brooks, Director of Engineering, Strategic Project Management, Medtronic, U.S. (invited)
- Mr. Charlie Kim, President and CEO, 121nexus, U.S. (confirmed)
- Mr. Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland (confirmed)
- Ms Tatjana Pathare, Artworks and Regulations Specialist within the Serialisation Project, F. Hoffmann La Roche (confirmed)
- Mr. Stefan Artlich, Director, Senior Project Manager 'Track&Trace', Bayer, Germany (invited)
Public Policy: Medical Devices
Regulatory requirements and initiatives from around the world related to medical devices – normally a closed group; it is only open for this session.
Moderators:
- Ms. Géraldine Lissalde-Bonnet, Public Policy Director, GS1 Global Office (confirmed)
- Ms. Jackie Elkin, Global Process Owner - Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
15:30 - 16:00
Coffee break
16:00 - 17:30
Two parallel streams - Participants can choose which stream to attend.
Panel - Pharmaceutical Traceability – learnings from around the world
Different manufacturers will present their respective approach to traceability, leveraging a combination best practices and lessons learned of implementation of regulatory and tender requirements for drug serialisation using GS1 standards. Join this session and participate in a discussion with experts who share their experiences and offer advice for traceability implementation.
Chaired by Mr. Senthil Rajaratnam, Affiliate Serialization Account Manager, Eli Lilly and Company, U.S. (confirmed)
- Mr. Lloyd Mager, Global Traceability Lead, AbbVie, U.S. (confirmed)
- Mr. Pascal Aulagnet, Senior Manager, Global Serialization - EMEA Client Partner, Pfizer, France (confirmed)
- Mr. Stefan Artlich, Director, Track & Trace, Bayer, Germany (confirmed)
Panel - UDI – AIDC Implementation experiences
Looking for more insight into the steps involved in the implementation of identification and marking (AIDC) of medical devices for the U.S. FDA UDI rule and other global UDI initiatives? The past few years have seen many implementation initiatives around the globe meant to meet the needs of UDI. Join this session to hear about the challenges and successes, and learn from our panellists as they share their practical experiences.
Chaired by Ms. Jackie Elkin, Global Process Owner Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
- Mr. John Terwilliger, GS1 Senior Consultant, Global Standards & Serialization Office, Abbott, U.S. (confirmed)
- Mr. Mark Hoyle, Technical Director, UDI, Commercial Regulatory Affairs, Teleflex, Ireland (confirmed)
- Mr. Georg Keller, Manager Regulatory Affairs, Labeling Coordinator, B.Braun / Aesculap AG, Germany (confirmed)
19:00 - 22:00
Networking event at John G. Shedd Aquarium hosted by GS1 US
Transportation will be provided beginning at 18:30 in the main lobby area of the hotel. Return shuttles from the Aquarium will be available as early as 8pm and will run on a loop with the last shuttle leaving at 22:15.
THURSDAY
06:45 - 08:45
Site Visits - Visit to Macy's Downtown Chicago
A morning tour before the store opens to see how RFID is used.
Max. group size: 20 attendees (split into two groups)
Meeting point: hotel lobby (to walk to the store)
A Continental breakfast is available afterwards at the conference venue
8:30 – 9:00
Welcome coffee
9:00 – 9:25
UDI in the US
Ms. Terrie Reed, Senior Advisor for UDI Adoption, U.S. Food and Drug Administration (confirmed)
9:00 - 10:30
Plenary session – UDI
UDI aims to establish a single device identification system that is consistent, unambiguous and globally standardised. The session provides an overview of the status on UDI across the world and informs on other initiatives regarding track & trace for medical devices.
9:25 – 9:50
UDI in Europe
Mr. Salvatore Scalzo, Policy and Legal Officer, Medical Devices, DG GROW, European Commission (confirmed)
9:50 – 10:10
UDI in Turkey
Dr. Yalçın Soysal, Head of Department, Department of Medical Devices Registration and Coordination, Ministry of Health, Turkey (confirmed)
10:10-10:30
Global Medical Technology Alliance discussing International Medical Device Regulators Forum (IMDRF)
Ms. Jackie Elkin, Global Process Owner Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S. (confirmed)
10:30-11:00
Coffee break
11:00 - 13:00
Plenary session – Imagine one world, one standard, one vision: Improving Patient Safety
11:00 - 11:10
Healthcare Provider Advisory Council (HPAC) Award
The GS1 HPAC provides two awards for:
- an individual who has contributed extensively to furthering GS1 Healthcare's work efforts over the years;
- a provider organisation that has implemented GS1 Standards for at least one process in their organisation.
11:10 – 11:30
Presentation of winner 1 of HPAC Award
11:10 - 11:30
Presentation of winner 2 of HPAC Award
11:50 – 12:10
Implementation of GS1 standards at Centro Medico Imbanaco
Mr. José Luis Sabogal, IT Manager, Centro Medico Imbanaco, Colombia (confirmed)
12:10 – 12:15
Invitation to next conference in Bogota, Colombia
Mr. Rafael Florez, CEO, GS1 Colombia (confirmed)
12:15 – 12:55
Inspirational speaker
Ms. Sorrel King, Founder, The Josie King Foundation, U.S. (confirmed)
12:55 – 13:00
Closing remark
GS1 Healthcare Tri-Chairs (confirmed)
13:30 - 18:00
Site Visits - Two parallel Options
Option 1. Visit to the Zebra Experience Centre
Visit to the Zebra Experience Centre to see GS1 standards applied with some of the latest AIDC technologies in a real-life environment.
Max. group size: 50 attendees
Meeting point: hotel lobby.
Time: 13:30 - 17:30 (Expected return at the hotel)
"To-go" lunch boxes will be provided
Option 2. Visit to the McKesson, DC
Tour to the McKesson regional Distribution Center to see this production, together with sophisticated product picking technologies, in action.
Max. group size: 60 attendees (split in two groups)
Meeting point: hotel lobby.
Time:
Group 1: 13:30 – 17:00 (Expected return at the hotel)
Group 2: 14:30 – 18:00 (Expected return at the hotel)
"To-go" lunch boxes will be provided.
FRIDAY
9:30 – 12:30
Visit to the Zebra Experience Centre (MO only)
A special MO visit to the Zebra Experience Center to see how GS1 standards are applied with the latest AIDC technologies in a real-life environment.
Meeting point: hotel lobby.
Please take care of your breakfast before the tour departs.