Conference Day 1

8:30 AM - 8:55 AM Registration and Welcome Coffee

8:55 AM - 9:00 AM PharmaIQ Welcome

9:00 AM - 9:10 AM Chairman’s Opening address

9:10 AM - 9:20 AM Icebreaker: What Are Your Event Objectives?

To boost networking and interactivity, the conference will begin with
an opportunity for everybody to get to know one another. Attendees
will then have 15minutes to discuss their key objectives for attending
the event. These will be used to influence discussions throughout
the entire conference. At the end of the second day the objectives
will be reviewed and there will be further opportunity to discuss any
remaining points.

Facilitated by the event chair

9:20 AM - 10:00 AM European Legislative Update: Incorporating MDR Guidance And UDI Legislation in the Global Market

Salvatore Scalzo, Policy and Legal Officer, European Commission
- Assess the current shift in global focus – from FDA to European MDR
- Understand the European Regulatory background to MDR and UDI policy development – what does the new legislation address?
- Discuss an implementation timeline of regulatory changes for new device developments, ongoing device developments and legacy devices

Salvatore Scalzo

Policy and Legal Officer
European Commission

10:00 AM - 10:40 AM Creating A Unified Strategy For Global Traceability Requirements

Terrie Reed, Senior Advisor for UDI Adoption , US Food & Drug Administration (FDA)
- Understand the similarities and differences between FDA and MDR regulations regarding traceability
- Identify a global roadmap to regulatory compliance – creating a single global strategy applicable across markets
- Map an implementation timeline – what can you be doing to streamline your implementation and reduce the risk of noncompliance?

Terrie Reed

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

10:40 AM - 11:10 AM Networking Coffee Break

11:10 AM - 11:50 AM Global UDI Implementation – Where Are We Really and What is Stopping us Moving Forward?

Mark Hoyle, UDI Global Lead, Teleflex
- Analyse the realities of UDI implementation at a global level from a manufacturer’s point of view
- Discuss the challenges to standardised implementation – what do we know? What do we need to know?
- What do the regulators need to know? Determine the key criteria for effective implementation as a manufacturer

Mark Hoyle

UDI Global Lead

11:50 AM - 12:30 PM UDI Implementation On A National Level – A Turkish Ministry Of Health Case Study

Ali Riza Demirbas, Hospitals Manager/ Health Management Expert, Turkish Ministry of Health
- Discuss the Turkish approach to device traceability
- Map the differences between FDA, MDR and Turkish regulatory requirements – what you need to do to comply in Turkey
- Leverage master data to increase patient safety – how the Turkish device master data impacts patient options and awareness

Ali Riza Demirbas

Hospitals Manager/ Health Management Expert
Turkish Ministry of Health

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:10 PM Know Your Requirements – Creating A Regulatory Map To Support Compliance

Geraldine Lissarde Bonnet, Director of Public Policy , GS1 Global Office
- Compare GS1 Standards and the MDR – mapping alignment in approaches
- Create a strategy for EU UDI compliance – looking at the EU landscape including Germany, UK (post Brexit), France and the Netherlands and how these systems can be approached in a unified fashion
- Understand the role of GS1 standardisation as a means of driving supply chain efficiencies

Geraldine Lissarde Bonnet

Director of Public Policy
GS1 Global Office

2:10 PM - 3:00 PM Interactive Round Tables

  1. Building the team – ensuring you plan ahead and recruit the broader team to build your implementation timeline
  2. Creating a flexible framework for implementation – taking a global perspective
  3. Analysing the Basic UDI DI – where does it fit in your global adoption process?
  4. Discuss the differences – Pharma Serialisation and Medical Device Traceability requirements; what can we learn from the pharma case experience?

2:50 PM - 3:20 PM Networking Coffee Break

3:20 PM - 4:00 PM UDI Implementation For The Customer – Considering The Needs Of The NHS

Jackie Pomroy, Head of Supply Chain and e-business, NHS South of England Procurement Services
- Assess how to translate the MDR into a usable national standard
- Analyse the UK Scan4Safety requirements and rollout
- Examine the implications of the Scan4Safety on patient safety and device quality management
- Consider your usability – what does your end customer need?

Jackie Pomroy

Head of Supply Chain and e-business
NHS South of England Procurement Services

4:00 PM - 4:40 PM Enhancing Your Transparency And Traceability To Improve Regulatory Submissions

Frank Pokrop, Director, Regulatory Affairs, BD
- Understand the role of supply chain and logistical transparency in enhancing regulatory compliance
- Discuss the delegation of responsibility – understanding the division of responsibility to ensure transparency
- Prepare for the move to real time traceability – putting in place a holistic data management system

Frank Pokrop

Director, Regulatory Affairs

4:40 PM - 5:20 PM Maximise The Change: Managing The Transition To UDI

Melissa Finocchio, Project Portfolio Leader, bioMerieux
- Discuss where to start for effective UDI implementation
- Analyse how to communicate this change to your team – driving compliance not complaints
- Identify your strengths – assigning responsibility through the team
- Examine your strategy – implement change in distinct parts, or implement holistic change together

Melissa Finocchio

Project Portfolio Leader

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

5:30 PM - 5:40 PM End of Conference Day One