Programme

The implementation of UDI systems has become crucial in the medical device industry, enabling improved traceability, safety, and post-market surveillance of medical devices across the globe. During this session, we will examine the regulatory frameworks established by various countries and regions. Expand your knowledge and gain a comprehensive understanding of the global UDI landscape, its impact, and the challenges it presents to stakeholders worldwide.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Dennis Black, UDI Program Director, Global Regulatory Affairs, BD (United States) | Helio Bomfim de Macedo Filho, Advisor, ANVISA (Brazil) | Tracey Duffy, First Assistant Secretary, Australian Government, Department of Health and Aged Care (Australia) | Silvia Ostuni, Legal and Policy Officer, European Commission (Belgium) | Pilar Hernández, Head of Clinical Research Unit, DNM (El Salvador).

In this session, we will explore strategies and best practices for streamlining the transition process of implementing Unique Device Identification (UDI) and Automatic Identification and Data Capture (AIDC) systems. Drawing from real-world implementation experiences, we will delve into the key challenges faced during the transition and share practical insights to enhance efficiency and timeliness.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Cyndi Poetker, Director Standards, Traceability & SCM, Abbott Laboratories (United States) | Nils Haugen, RAQ Data & Syndication Lead, UDI Lead, 3M (United States), Jodi King, Program Director UDI, Philips (United States) | Tom Jones, Program Director UDI, J&J (United States) | Tania Pearson, Regulator Systems Director, Medtronic (United States) | Fabien Rouet, Global Master Data Management Program Director, bioMérieux (France).

With the ever-increasing complexity of medical supply chains and the need for accurate tracking and traceability, healthcare providers are seeking innovative solutions to streamline their medical devices management processes. We will explore best practices and strategies for healthcare providers to effectively leverage the new UDI mandates to enhance their operations.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Rafael Vitolo, Project Leader, Systems Analyst, Hospital Israelita Albert Einstein (Brazil), Simeng Wang, Engineer, Medical Consumables Group Management Specialist, The First Affiliated Hospital of Zhengzhou University (China) | Tony Scanio, Director, Data Management and Business Intelligence, International Operations. Christus Health (United States) | Claudia Brun, Pharmacist, Hospital Alemán (Argentina).

In this session industry experts and regulatory authorities come together to discuss the evolving landscape of pharmaceutical regulations. The session explores the latest trends in the regulatory sphere and provides insights into the lessons learned from past experiences. Attendees can expect to gain a comprehensive understanding of the regulatory environment, its impact on the pharmaceutical industry, and the strategies needed to navigate the future successfully.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Gregory Goger, Global Traceability Lead- AbbVie | Dr. Ramy Guirguis, Senior Information Technology Advisor, USAID/GHTASC (United States) | Andreas Walter, General Manager, European Medicines Verification System (EMVO) (Belgium).

Join us for an insightful session that explores how GS1 standards can be effectively implemented within the diverse stakeholders of the pharmaceutical supply chain to enhance operational efficiency, ensure product integrity, and improve patient safety. Through real-world case studies and expert insights, you will gain a comprehensive understanding of the benefits and challenges associated with implementing GS1 standards.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Scott Mooney, Vice President Distribution Operations, McKesson Corporation (United States) | Erika Diago Rufino, Director Regulatory Affairs, Janssen Pharmaceutical (Brazil), Aline Bortone, Global Serialisation Logistics Operations Lead, Pfizer (Netherlands) | Juliana Filizzola, Head of Quality and Regulatory Affairs - Warehouse and Transportation,  DHL Supply Chain (Brazil).

This session addresses the challenges and opportunities in leveraging digital technologies and the transformative power of GS1 Digital Link, a cutting-edge technology that is revolutionising connectivity in supply chains to ensure the accuracy, privacy, and security of healthcare data. Gain insights into the latest advancements driving a more efficient and patient-centric healthcare ecosystem.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: to be confirmed | Gert Vleugels, Head of CoE Track and Trace, Merck | Biopharma | SNO (Switzerland) | Haroon Taylor, Senior Data Scientist, YewMaker (UK)| Grant Courtney, Traceability Lead, UNICEF (UK) |  Elizabeth Scanlan, Scientific Communication Specialist, European Medicines Agency (The Netherlands).

This session aims to shed light on the pivotal role of global standards shaping the technological ecosystem, enabling harmonisation, efficiency, and collaboration across borders, industries, and disciplines in an increasingly interconnected and technology-driven world. By providing a common framework and guidelines, global standards facilitate the development and implementation of cutting-edge solutions such as telemedicine, electronic health records, wearable devices, and artificial intelligence.

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Pascal Aulagnet, Market & Regulatory Engagement Lead – Global Supply Chain – Serialisation Center of Excellence , Pfizer (France) | Esteban Lizarazo, CEO, Vitalis Pharmaceuticals and Cranfield University (Colombia), Nilson Gonçalves Malta, Hospital Automation Manager, Albert Einstein Hospital (Brazil), Pavan Kumar Heda, Ph.D.,VP, Supply Chain – Enterprise Global Trade Controls and Network Strategy, J&J (United States).

Hybrid (In-person and virtual session) | Open to all attendees | Session chair: Cyndi Poetker, Director Standards, Traceability & SCM, Abbott Laboratories (USA) | Javier Sala Mercado, Vice CMO & COO Model Institute of Cardiology, Cordoba (Argentina) | Nielson Malta, Automation Manager, Albert Einstein Hospital (Brazil) | Javier Sala Mercado, Vice CMO & COO Model Institute of Cardiology, Cordoba (Argentina).