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Day One Agenda
Wednesday, September 24

*All Times Listed in Eastern Time

9:30   VIRTUAL EVENT SIGN-ON 

9:55   OPENING REMARKS 

10:00   KEYNOTE PANEL: 2025 EVOLUTION OF LABELING ROLE IN MEDICAL DEVICE & DIAGNOSTIC LANDSCAPES
• Compliance amidst ongoing regulatory requirement changes
• Strengthening digital capabilities in line with global trends
• Global move towards implementing official label regulations
• Accelerating the notified body certification approval process
Panelists:
Dawn Fowler, Medtech Labeling & UDI Expert
Matt Wolf, VERATHON
Alejandro Manunta, INTEGER
Mia Beste, MEDTRONIC 

10:45   UKCA MARK EXPLICIT DECLARATIONS AND DEADLINES FOR COMPLIANCE
• Labeling specifications for ensuring UKCA mark approvals as needed
• Explicit deadlines to gain approval according to previous CE markings
          » MDR/IVDR/IVDD CE
          » MDD/AIMDD CE
• Suggested timelines for preparation of changes and enforcements
Neil Plumridge, Regulatory Affairs Manager
BIVDA

11:30   COFFEE BREAK

12:00   PROVIDING NECESSARY TRANSLATIONS WITH SUSTAINABILITY IN MIND
• Defining of product labeling requirements
• Potential for outsourcing translation translation services
• Utilizing electronic informational mediums whenever available
• Comprehensive design reviews for minimizing print error waste
Laura Clark, Technical Communications Associate Director – GHI, Regulatory
EXACT SCIENCES

12:45  FROM STATIC TO STRATEGIC: DIGITIZING MEDICAL DEVICE LABELING FOR GLOBAL
SCALE
Labeling in the medical device industry has traditionally been a static, manual process — slow to change, hard to control, and vulnerable to compliance risk. But with increasing global regulatory demands and the complexity of multilingual labeling, outdated approaches are no longer sustainable. This session explores how leading medtech companies are digitizing and automating their labeling processes to improve compliance, accelerate change control, and gain global scalability. Learn how moving from static files to strategic, composable content enables full traceability, faster updates, and a labeling function built for the future of connected healthcare.
Sharad Khusal, Senior Vice President Sales – Americas
KALLIK

1:30   COFFEE BREAK

2:00   SMALL GROUP DISCUSSION: COST-EFFECTIVE TOOLS FOR MAINTAINING LEGACY DEVICE COMPLIANCE WITH ONGOING REGULATORY UPDATES
With manufacturers steadily expanding medical device releases within the evolving global market, labeling requirements continue to evolve at the same pace, tasking labeling executives with the ongoing cycle of maintaining label compliance for all legacy devices. This interactive discussion will break audience members into self-determined groups to share proven tactics in keeping up to date of the newest regulations, ensuring updated performance data availability, and promptly upgrading labeling strategies as needed.
Laura Johnson, Manager, Labeling Center of Excellence
BRACCO MEDICAL TECHNOLOGIES
Anita Stever, Principle Technical Writer, Labeling Center of Excellence
BRACCO MEDICAL TECHNOLOGIES

2:30   MAXIMIZING UDI PRACTICAL USES WITH ONGOING GLOBAL EXPANSIONS
• Ensuring adequate oversight for global scale UDI implementation
• Recognition of distinct UDI applications and requirements by region
• Harmonization of UDI requirements with international regulations
Dawn Fowler, Medtech Labeling & UDI Expert 

3:15   EUDAMED DATABASE ROLLOUT TIMELINE AND USE PREPARATION
• Evaluation of latest timeline declaration and plausibility
• Similarity comparison to comparable international databases
          » Australia TGA
          » Saudi Arabia MDDB
• Preparation for maximizing database contributions and utilization
• Areas included preemptively in EUDAMED registration obligations
Dawn Fowler, Medtech Labeling & UDI Expert

4:00 LABELING REQUIREMENTS INTRODUCED WITHIN FLOURISHING GLOBAL MARKETS AS OF 2025
• Comparing pilots in new regions with established market regulations
          » Egypt
          » Saudi Arabia
          » Brazil
• Expected digital labeling permissions allowed for immediate use
• Implications of global expansion of labeling regulatory requirements
Christine Wahba, Senior Regulatory Affairs and Quality Assurance Specialist MEA, Align Technology 

4:45   Closing Remarks & End of Day 1

Day Two Agenda
Thursday, September 25

*All Times Listed in Eastern Time

9:30   VIRTUAL SIGN ON

9:55   OPENING REMARKS

10:00   ENSURING ADVANTAGEOUS USES OF NEW QR CODE TECHNOLOGY WITHIN LABELING
• Safety concerns regarding improper use for malicious reasoning
• Beneficial utilizations of QR Codes for digital labeling materials
• Expectations of forthcoming regulations for standardized uses
Roger Peterson, Senior Manager, Global Labeling, Regulatory
ARTHREX

10:45   PANEL DISCUSSION: EFFECTIVELY GAINING NOTIFIED BODY APPROVAL FOR LABELING CERTIFICATION MARKS
• Circumventing common reasonings for design approval challenges
• Securing alignment of label information, symbols, and translations
• Precise questioning to maximize appeal cycle process productivity
• Expanding on labelling details provided for further proof of accuracy
Christine Wahba, ALIGN TECHNOLOGY
Honey Dayani, INTUITIVE
Laura Johnson, BRACCO MEDICAL TECHNOLOGIES

11:30   COFFEE & NETWORKING BREAK

12:00   LEGAL PERSPECTIVE: APPLICATIONS OF FDA LDT RULING ON LABELING FOR LABORATORIES
• Deadlines for compliance across all stages of LDT phase out policy
• Labeling expectations and applicable requirements for non-distributors
• Globally equivalent regulations likely to harmonize subsequently
• Developing minimal essential use disclosures for confidentiality
Laura Dona, Associate
ARNALL GOLDEN GREGORY LLP

12:45   REAL-WORLD APPLICABILITY: APPLICATIONS OF FDA LDT RULING ON LABELING FOR LABORATORIES
• Deadlines for compliance across all stages of LDT phase out policy
• Labeling expectations and applicable requirements for non-distributors
• Globally equivalent regulations likely to harmonize subsequently
• Developing minimal essential use disclosures for confidentiality
Irene Hsieh, Sr. Director, Regulatory Affairs & Quality Assurance
CLEARNOTE HEALTH

1:30   COFFEE BREAK

2:00   PANEL DISCUSSION: ALIGNING LABELING TEAMS MINDSET TO EMBRACE ADVANCING TECHNOLOGIES
• Continuous trainings in line with labeling technological advances
• Pinpointing challenging tasks with potential for supplemental tech
• Addressing common concerns due to longstanding routine changes
• Cost- and time-efficiency benefits from implementing technology
Moderator:
Laura Johnson, LOFTWARE
Panelists:
Selena Ingram, FRESENIUS KABI
Matt Wolf, VERATHON
Pankaj Chandak, MEDTRONIC

2:45   TECHNOLOGICAL TOOLS TO CENTRALIZE CROSS-FUNCTIONAL RESPONSIBILITIES
• Tools available for resource sharing to improve knowledge standards
• Potential applications for stable and constant communications
• Software for improving streamlined in-house design review
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence
INTEGER

3:30   EIFU BEST PRACTICES: CONSIDERATIONS FOR USABILITY AND COMPLIANCE
• Essential aspects of eIFU distribution, tools, and processes
• Labeling transition from print to eIFU, considering physical labels and digital formats
• Countries and regions currently accepting eIFU documentation
Selena Ingram, Sr. Labeling Technology Specialist
FRESENIUS KABI

4:15   Closing Remarks & Conference Conclusion