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Conference Day One

8:15 AM - 8:45 AM Registration & Networking Coffee

8:50 AM - 9:00 AM Chairman’s Opening Remarks

Frank Pokrop, Director, Regulatory Affairs, BD

Frank Pokrop

Director, Regulatory Affairs
BD

9:00 AM - NaN:NaN AM European Legislative Update: Incorporating UDI Legislation into the Eudamed Framework

Andy Crosbie, Head of Biosciences and Implants, Devices Division, MHRA
  • Key challenges associated with attaining coherency in legislative framework
  • Key issues and uncertainties related to incorporating upcoming UDI regulations into the wider six pillars of Eudamed
  • Exploration of why this is much more difficult than the stand alone system created by the FDA and UMA

Andy Crosbie

Head of Biosciences and Implants, Devices Division
MHRA

9:45 AM - 10:15 AM Incorporating HIBC into UDI

Ton van Zijl, Chairman, EHIBCC
  • Outline of the incorporation of HIBC into UDI
  • Implications upon universality, ease of use and international synergy
  • Explanation of the significant benefits experienced by both manufacturers and healthcare providers in standardisation

Ton van Zijl

Chairman
EHIBCC

10:15 AM - 10:45 AM Business Card Exchange Networking Icebreaker

10:45 AM - 11:15 AM Networking Coffee Break

11:15 AM - 12:00 PM Best Practice Preparation for the European UDI & Regulatory Landscape

Geraldine Lissarde Bonnet, Director of Public Policy , GS1 Global Office
  • Update on expected time frame for adoption and implementation of the EU UDI system
  • The EU UDI system in the EU’s landscape, including Germany, UK (post Brexit), France and The Netherlands etc and how these systems will be synergized
  • The EU UDI system in the global landscape, including the USA, China, Japan and Turkey and how to ensure a globally harmonized implementation
  • How GS1 global standards translate to the EU UDI system and how to prepare for implementation

Geraldine Lissarde Bonnet

Director of Public Policy
GS1 Global Office

12:00 PM - 12:30 PM The Evolving UDI Landscape and its Effect on Medical Device Safety and Quality

Holger Braemer, Vice President Europe, USDM Life Sciences
  • Understanding the goals of IMDRF, particularly in terms of identical (or nearly identical) UDI requirements for the marking of device labels and packages
  • Tackling the challenge to collect, normalize, verify, store, submit and manage the different device meta-data and other attributes that each of these systems will require for the same device
  • An increased focused on device safety and quality – and the ability of systems to efficiently identify device quality problems and concerns about their use in specific patients and patient populations (including, for example, FDA’s “National Evaluation System for health Technology” and “Case for Quality”).

Holger Braemer

Vice President Europe
USDM Life Sciences

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:00 PM GMDN – The Relevancy and Requirements in Relation to UDI

Mark Wasmuth, CEO, GMDN Agency
  • Methods of accessing the GMDN for all stakeholders
  • Explanation of how GMDN can be used to ensure full compliance with the UDI rulings
  • GMDN generic term creation in relation to new product innovation
  • Wider use of GMDN within the medical industry

Mark Wasmuth

CEO
GMDN Agency

2:00 PM - 2:30 PM Delivering Transparency, Flexibility and Compliance by adopting a Single, Integrated, Cloud-Based, Labelling & Artwork Platform

Neil Gleghorn , Founder & CEO , Kallik Ltd
  • Bring transparency across all production facilities and contract manufactures sites
  • Prove compliance of product labelling to UDI – at the touch of a button
  • Have flexibility to configure the labelling solution to evolve with the variety of UDI regulations across global markets
  • Leveraging UDI, to drive efficiencies across your origination

Neil Gleghorn

Founder & CEO
Kallik Ltd
  • Following the final text of the MDR draft, there remains some lack of clarity on what a 'basic UDI' is
  • Exploration of what is meant by 'basic UDI'
  • How will this work?
  • How does this dove tail with the existing frameworks?
  • What are the implications?

Ton van Zijl

Chairman
EHIBCC

Andy Crosbie

Head of Biosciences and Implants, Devices Division
MHRA

Mark Hoyle

UDI Global Lead
Teleflex

3:00 PM - 3:30 PM Networking Coffee Break

  • Update on UDI implementation and development in the USA
  • Current shift in focus to adoption of UDIs by healthcare providers
  • Additional focus upon improving data quality and identifying issues
  • How can the current database implementation be enhanced?

Terrie Reed

Senior Advisor for UDI Adoption
US Food & Drug Administration (FDA)

Indira Konduri

GUDID Program Manager
FDA

4:15 PM - 4:45 PM UDI Implementation Outside of the EU – Spotlight on Turkey

In preparation for a day of case studies from manufacturers and end users, this discussion will be dedicated to outlining potential short and long term benefits of UDI implementation, including:
  • Practitioners and healthcare providers
  • Patients
  • Authorities and governing bodies
  • Medical device manfacturers
What are the key drawbacks that may affect each of these stakeholders?

4:45 PM - 5:15 PM Interactive Round Up Discussion Session: UDI Beyond Legislation – Benefits and Drawbacks for all Stakeholders

In preparation for a day of case studies from manufacturers and end users, this discussion will be dedicated to outlining potential short and long term benefits of UDI implementation, including:
  • Practitioners and healthcare providers
  • Patients
  • Authorities and governing bodies
  • Medical device manfacturers
What are the key drawbacks that may affect each of these stakeholders?

5:20 PM - 5:30 PM Chairman’s Summary and Close of Day One

Frank Pokrop, Director, Regulatory Affairs, BD

Frank Pokrop

Director, Regulatory Affairs
BD