A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, September 25

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
Ardi Batmanghelidj, CEO
INNOVATUM

9:00   OPENING ICE BREAKER: SHARING INSIGHTS INTO TECH TOOLS TO STREAMLINE LABELING PROCESSES
The opening ice breaker will kick-off the event with an opportunity for all participants to move around the conference room to meet new delegates and engage in short and targeted discussions. In this interactive session, participants are encouraged to briefly share perspectives on any type of technology that has positively impacted label creation, management and/or delivery. Furthermore, participants in this warm-up session have the chance to build contacts with industry peers at the very start of the event, kicking off the program networking platform.

9:30   DEVELOPING A SOLID RATIONALE FOR LABEL MANAGEMENT SOFTWARE SELECTION & CORPORATE BUY-IN
• Needs analysis & determining selection criteria
• Key software characteristics & potential structure
• Developing a business case for leadership
• Impact of software on market release & ROI
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence
INTEGER

10:15   COFFEE & NETWORKING BREAK

10:45   EXCHANGE GROUPS: ADVANCED KNOWLEDGE IN LABEL MANAGEMENT & OPTIMIZATION TECHNOLOGY
With differing levels of knowledge, participants in this peer to peer learning session are invited to delve into facilitated small group discussions divided per experience and current focus. The ability to select which group to join provides attendees with the opportunity to tailor the learning experience and concentrate either on introductory information, practical insight into implementation steps, or finally, strategies to optimize the use of existing labeling management tools.
• Group 1 – Introduction to label management tools & selection criteria
• Group 2 – Sharing lessons to maximize label management tech
Ardi Batmanghelidj, CEO
INNOVATUM

11:30   REALISTIC APPROACH TO THE USE OF AI IN LABELING MANAGEMENT
• Myth busting the AI trend & applicability to LAM
• Digitalization & automation of labeling content population
• Concerns in control & validation of AI-generated labels
• Investment considerations for AI leveraging digitalization
Irene Hsieh, Sr. Director, Regulatory Affairs & Quality Assurance
ClearNote Health

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15   INTERACTIVE POLLING: COMPARING LABELING TEAM POSITIONS WITHIN THE COMPANY 
From one organization to the next, labeling teams are housed in various corporate departments, such as R&D, Quality, Regulatory and more. This interactive polling session will enable a comparison of different positions for labeling teams within the corporate structure and debate pros and cons to each structure.
Juan Preciado, Labeling Engineer
INTEGER

2:00   PANEL DISCUSSION: MAKING THE LABELING VOICE HEARD & DRIVING AN ORGANIZATIONAL SHIFT
• Advocacy opportunities within the company:
        » Educating other departments on the labeling team’s needs
        » Positioning labeling as an early-on priority
        » Establishing a centralized labeling data system
• Workflow structures to tackle significant labeling initiatives
• Overcoming common communication challenges with management
Dawn Fowler, Medtech Labeling & UDI Expert
Adhiraj Mamak, Senior Manager, Global Quality Strategy & Alliances
ILLUMINA
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence
INTEGER

2:45   COFFEE & NETWORKING BREAK

3:15   FOCUS ON EVOLVING UDI TECHNICAL CHALLENGES & SOLUTIONS
• Status overview of technical challenges reported by the industry
• Addressing complexities with specific requirements internationally
• Ongoing initiatives to support manufacturers & outlook into next steps
Dawn Fowler, MedTech Labeling & UDi Expert

4:00   ESTABLISHING A MARKET-SPECIFIC APPROACH TO LABELING PROVISIONS ON THE GLOBAL LEVEL
• Setting up a pilot line in the distribution center for Country Specific Labeling
• Scaling the pilot to full scale Country Specific Labeling
• Best practices & lessons learned to optimize processes
Taylor Bean, Labeling Solutions Manager
NETWORK PARTNERS GROUP

4:45   PANEL DISCUSSION: FOUNDATIONAL PILLARS TO EFFICIENTLY MANAGE CONTINUOUSLY EVOLVING REQUIREMENTS
• Keeping abreast of new & updated rules internationally
• Ensuring precision in the interpretation of new requirements
• Swift integration & launch of the upgraded labeling strategy
• Data management strategies to maintain increasing volumes
• Efficiently communicating with other corporate departments
Dai Wortman, Senior Manager Global Label Development & Design
ILLUMINA
Adhiraj Mamak, Senior Manager, Global Quality Strategy & Alliances
ILLUMINA

5:30   Closing Remarks & End of Day 1

Day Two Agenda
Thursday, September 26

8:30   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
Ardi Batmanghelidj, CEO
INNOVATUM

9:00   DEEP DIVE INTO EUROPEAN UPDATES OUTSIDE OF THE EU MDR
• Developments in the UK’s regulatory framework
• EU Packaging Directive impact on labeling
• Environmental requirements & Green Deal
Neil Plumridge, Chair of Environmental Regulatory Work Party
BIVDA, BRITISH IN VITRO DIAGNOSTICS ASSOCIATION

9:45   INDUSTRY-SPECIFIC GROUP DISCUSSIONS: DIRECTLY ENGAGING WITH NOTIFIED BODIES TO DIVE DEEPER INTO MDR & IVDR COMPLIANCE
With MDR and IVDR fairly clarified and understood within the industry at this time, labeling teams’ focus shifts to more precise areas of insight pertaining to Notified Body interpretations and reviews. This informal, industry-specific group discussion format enables participants to engage directly with Notified Bodies and see ongoing questions answered.
Haijuan Jane Li, IVD Product Reviewer
GMED NA
Julien Senac, Global Director, IVD Focus Team
TÜV SÜD

10:30   COFFEE & NETWORKING BREAK

11:00   ANALYSIS OF THE EU COMMISSION’S RESPONSE TO C(2021) STANDARDIZATION REQUEST & IMPACT ON LABELING
• Amendment to ISO:15223 & Authorized Rep symbol
• Addressing the follow-on impact on ISO 20417
• Ensuring ISOs are kept on the M575 standardization list
• Commission’s next steps & how to prepare as an industry
Roger Peterson, Senior Manager, Global Labeling, Regulatory
ARTHREX

11:45   CONTINUOUS MAINTENANCE OF A ROBUST GLOBAL UDI STRATEGY
• Exploring recent & most impactful regulatory updates
• Managing & sustaining a flexible, global UDI strategy
• Efficiencies in collaborations between UDI & Labeling teams
Tania Pearson, Regulatory Systems Director
MEDTRONIC

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   DISSECTING THE FDA QMSR FINAL RULE & IMPACT ON LABELING
• Clarification of the new rule & relevance to labeling
• Performing a gap assessment to identify areas of focus
• Mapping out an execution plan to swiftly reach compliance
Paul Gadiock, Partner
MCDERMOTT WILL & EMERY

2:15   LABELING LDTs: UNPACKING LABELING REQUIREMENTS UNDER THE LDT FINAL RULE
• Review of the LDT Final Rule & associated timelines
• Applying device labeling requirements to LDTs
• Other impacts for device & diagnostic companies
Amy Leiser, Special Counsel
COVINGTON & BURLING

3:00   Closing Remarks & Conference Conclusion