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Medical Device and Diagnostic Labeling Workshop Intensive

September 20, 2018 | San Diego, CA

Hilton Garden Inn San Diego Downtown/Bayside

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SEPTEMBER 20, 2018 | WORKSHOP SCHEDULE

8:00 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSONS OPENING REMARKS & ICE BREAKER ACTIVITY

9:00 MASTERCLASS: EU MEDICAL DEVICE REGULATION (MDR): NEW LABELING REQUIREMENTS & BASIC UDI-DI
The EU MDR has enacted some of the most impactful changes in medical device regulation in the past decade. Key provisions within the MDR specific to labeling present an expanded scope, enhanced requirements for translations and instructions for use (IFU), and initiatives towards greater transparency and traceability. An intensive review of applicable regulations and processes for implementation and management will ensure a smooth transition and increased adherence.

  • Clarification of MDR measures:
    • Additional label data
    • Enhanced authority scrutiny
    • Ad/Promo labeling & claims
    • Specifics for sterile products
  • Key EU UDI requirements
  • Redefinition of economic operators
  • Efficient use of the transition period

Felicia Hosey , Senior Principal Specialist, REGULATORY AND QUALITY SOLUTIONS LLC (R&Q)

 

10:00 PANEL DISCUSSION: ENHANCING LABEL COMPLIANCE THROUGH INTERNATIONAL STANDARDS 
The requirements for device and diagnostic labeling change dramatically from one market to another and require continuous updates for effective management. Translating and interpreting global label regulations is an especially difficult and time consuming task, particularly when products are marketed in multiple countries. Hearing practical industry perspectives on how international standards can enhance label compliance will provide attendees with greater insight to facilitate the development of continuously compliant labels.

  • Identifying label requirements in various ISOs
  • ISO applicability to:
    • Labeling operations
    • UDI compliance
    • Translation management
  • Labeling specifics in EN-ISOs

PANELISTS:
Maritza Marquez, EU MDR GRA Labeling Team, ALCON LABORATORIES

Lesley Wilson, Labeling Manager, ABBOTT

Felicia Hosey , Senior Principal Specialist, REGULATORY AND QUALITY SOLUTIONS LLC (R&Q)

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 CASE STUDY: UDI PROGRAM FLEXIBILITY & ADAPTATION TO EVOLVING REQUIREMENTS
Although many manufacturers have already complied with FDA regulations surrounding the creation and placement of UDI on products, regulations are continuing to evolve and the EU MDR and IVDR takes UDI a step further, requiring modification of processes currently in place. Beyond European directives as part of the IVDR, other international regions have also expanded the utilization and of UDI, requiring manufacturers to be prepared for further integration of technology and processes. Combining review of regulatory mandates alongside practical steps in order to ensure label compliance, a device manufacturers’ perspective will provide participants with an opportunity to review and benchmark processes.

  • New traceability & UDI requirements in OUS markets
  • Integration of EU MDR/IVDR specific regulatory demands
  • Addressing provision conflicts in program architecture
  • Expediting the integration of new regulatory mandates
  • Encountered challenges and lessons learned to date

Tania Pearson, Senior Program Manager| Corporate Regulatory, MEDTRONIC

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 DECODING COMPLIANCE IN US & OUS AD/PROMO LABELING CONTENT
Medical device promotional marketing materials can be considered as a label in certain countries and are becoming a greater area of international regulatory concern as the claims on promotional marketing materials must be supported by clinical evidence. Thorough knowledge on which countries do consider promotional marketing materials as labels, as well as the level of clinical evidence required, will better assist companies in demonstrating label compliance around the globe.

  • Regulatory requirements: focus on US & EU compliance
  • Defining product-specific false or misleading promotional claims
  • Methods to achieve a sound balance between benefits & risk
  • Determining clinical evidence to support claims

Stephanie Eliopoulos, Director, Promotional LabelingMEDTRONIC

 

1:45 IMPLEMENTATION CASE STUDIES: TAKING LABELING TO THE NEXT LEVEL VIA CMS, MDM & ELS
With a plethora of benefits to offer, the ongoing shift towards the implementation of centralized data sources to optimize labeling operations remains at the forefront of device and diagnostic manufacturer’s interest and priorities. Whether through the use of a Content Management System (CMS), Master Data Management (MDM) or an Enterprise Labeling Solution (ELS), creating a single source for all label-related data enables faster access to information, extensively decreases human-error risks and ensures content alignment on a global level. Focusing on peers’ direct experience, insights into the practical aspects of initiating such a shift and leading the project to successful completion will be shared through short and targeted case studies.

  • High-level view of
    • Selection criteria
    • Implementation
  • Technology pros & cons
  • Lessons learned

Roger Peterson, Manager, Global Labeling Systems, ARTHREX

 

VYAIRE MEDICAL CASE STUDY: ACHIEVING CORPORATE REBRANDING VIA ELS IMPLEMENTATION

  • Building the business case for leadership
  • Organizational Buy-In & education
  • Implementation Timeline & benefits to date
  • Lessons Learned

Erin Salbilla, Quality Manager, Labeling, VYAIRE MEDICAL

 

2:45 COFFEE & NETWORKING BREAK

 

3:15 EXECUTIVE ROUNDTABLE: RATIONALE FOR LABEL MANAGEMENT SOFTWARE SELECTION & CORPORATE BUY-IN
Medical device corporations throughout the industry are increasingly looking towards label content management software to optimize processes for label development and compliance assurance. With numerous evolving components and regular changes to regulatory requirements for label content, the use of such technology not only streamlines label creation, but also acts as a quality assurance monitor. At the same time, labeling executives find challenges in securing funding for investing in such technologies, requiring the development of a succinct and compelling business case.

  • Needs analysis & determining selection criteria
  • Key software characteristics & potential structure
  • Developing a business case for leadership
  • Impact of software on market release & ROI

PANELISTS:
Roger Peterson, Manager, Global Labeling Systems, ARTHREX

Erin Salbilla, Quality Manager, Labeling, VYAIRE MEDICAL

 

4:00 CLOSING REMARKS & WORKSHOP CONCLUSION

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