The Pulse of US UDI Implementation and Global UDI Impacts скачать в хорошем качестве

The Pulse of US UDI Implementation and Global UDI Impacts

An anniversary marks the occasion to look back and review successes, and to look to the future to identify areas that provide a platform for expansion, improvements and opportunities. The 2023 AIM UDI Seminar will commemorate the 10-year anniversary of the release of the US FDA UDI Rule and the proliferation of UDI-related activities globally. Successes to date achieved through the dedicated efforts of all the industry stakeholders will be acknowledged and some of the challenges and issues yet to be resolved will be discussed as we move past this first decade of implementation. Agenda US FDA’s UDI: Ten Years of Success and What’s on the Horizon Speaker: Indira Konduri, Deputy Director, Division of Regulatory Programs 3 (DRP3), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (invited) Ms. Konduri will provide a snapshot of the significant progress made over the past decade, including the number of items now contained in the US FDA’s Global Unique Identification Database (GUDID), and the latest enhancements with AccessGUDID. What lies ahead for the US UDI System will also be shared. Unresolved Issues Impacting Implementation Speaker: Kevin Capatch, Director of Process Engineering, Geisinger Health System Mr. Capatch will share the UDI achievements he has witnessed from his vantage point of patient care and safety. You will be guided through a real-world glimpse into the realities of a hospital system and the issues that are impeding UDI implementation within the healthcare industry. This is an opportunity for the collective whole to learn of the nuances and provide suggestions on how to reduce the burdens currently experienced during patient care and/or to become part of solutions moving forward. Reflections on Achievements and Opportunities for Future Expansion Speakers: Jay Crowley, VP of Medical Device Solutions and Services, USDM Life Science; Dennis Black, UDI Program Director, BD; Natalia Wilson, Executive Director, Center for Healthcare Delivery and Policy, Arizona State University and Adjunct Assistant Professor, Mayo Clinic Alix School of Medicine These industry pioneers, who have been invested in UDI from the beginning, will share their perceptions of all the advancements that have been made over the past decade, and more specifically, drill down into the foundational concepts that are not universally understood, the unfolding global regulatory impacts, the need for more cohesive cross-silo synergy, and issues that still need to be addressed to allow for future success. Ask The Experts Open Q&A with Speakers