7TH SEMI-ANNUAL DEVICE AND DIAGNOSTIC LABELING CONFERENCE

June 26–27, 2017 | San Jose, CA
DOWNLOAD AGENDAREGISTER NOW

DAY ONE | MONDAY, JUNE 26

7:00 REGISTRATION & WELCOME COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS

8:00 EXCHANGE GROUP ICE BREAKER: UPDATED & NEW LABELING REQUIREMENTS SHARING
This interactive ice breaker session will open the event with an opportunity for all participants to meet with peers in the conference room, and engage in discussion. Given the challenge of continuously remaining abreast of evolving rules for labeling in and outside of the US, this small group discussion format will focus on sharing knowledge and intelligence pertinent to new provisions. Furthermore, participants in this warm-up session will not only gain invaluable insight into important requirements that might have been overseen, but also build contacts with industry peers, kicking off the event networking platform.

8:30 COUNTRY-SPECIFIC LABELING RULES & PRACTICES: OVERCOMING CHALLENGES WITH EVOLVING FRAMEWORKS
With medical technology products shipped to various markets worldwide, device and diagnostic labeling executives must ensure a sound understanding of country-specific labeling rules to continuously meet compliance. Health authority requirements evolve at a rapid pace, and remaining abreast of new provisions impacting labeling is an ongoing hurdle for the industry, especially for markets in which the corporation does not have local representation. Furthermore, labeling compliance goes beyond following rules, and must include the target market’s cultural perspective to guarantee safety messages are conveyed in the appropriate manner to end-users. By diving deeply into common labeling hurdles specific to Europe, Asia and Latin America, clarity will be provided on new and existing rules as well as health authority expectations pertinent to each market.

PART 1: EU MDR & IVDR IMPACT; NEW LABELING REQUIREMENTS

  • Competent authority label scrutiny & approval
  • EU regulatory shift & new labeling measures
  • Re-definition of importers & distributors
  • Timelines for implementation & compliance

Laure Le Calvé, Lawyer, L. C. H. EUROPE

 

9:15 PART 2: LABELING RULES & EXPECTATIONS IN ASIAN MARKETS

  • Recent updates to CFDA & label requirements
  • Meeting compliance with Japanese labeling rules
  • Specific labeling hurdles in further Asian countries
  • Clear understanding of cultural expectations

Mercedes Bayani, Global Director, Regulatory Affairs, BIONESS

 

10:00 COFFEE & NETWORKING BREAK

 

10:30 DESIGNING & DEPLOYING A ROBUST REGULATORY LABELING MANAGEMENT STRATEGY

  • Incorporating a regulatory focus into labeling teams
  • Holistic approach to international rules
  • Resources ensuring timely awareness of new provisions
  • Accuracy in translation of regulations into English
  • Integrating rules within the existing strategy
  • Approval of the updated regulatory labeling strategy

Melissa Finocchio, Senior Director, Global Product Labeling & Documentation
BIOMERIEUX GLOBAL HQ

 

11:15 EXPLORING THE UNIVERSE OF REGULATED LABELING, FOCUS OVERLAPS & EFFICIENCIES TO BE GAINED
As regulatory requirements increase in number and stringency around the globe, the challenges within life sciences labeling for catering to various localized requirements in a global environment continue to mount. An appropriate understanding of the interrelated elements within the universe that is life sciences labeling is key. This session will analyze intersections and differences between various requirements in this field and opportunities for improving efficiency will be conveyed. Improved efficiency minimizes risk and consequently also diminishes cost. To understand the interplay and, therefore, optimization opportunities across various related life sciences labeling elements it is crucial to understand the intersections across these various elements before true efficiencies and optimization may be realized.

  • Designing & printing of labels
  • Country specific requirements & deferred label printing
  • Management & submission of regulatory data
  • Label inspection / Vision inspection
  • Management of electronic documents (eIFU, manuals, guides, etc.)

Ardi Batmanghelidj, President, INNOVATUM

 

12:00 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 INSIGHTS INTO RECENT FDA GUIDANCE IMPACTING LABELING COMPLIANCE
In 2016, two new rules have triggered much interest from life science labeling professionals, eager to obtain further insight into FDA expectations. The Human Factors Usability Testing guidance, as well as the final rule on Use of Symbols in Labeling introduce new requirements as well as opportunities for the industry to optimize the development of user-friendly labels and instructions for use. In order to promptly integrate provisions into labeling strategies, a clear interpretation of the rules is pivotal to ensure compliance and label approval.

PART 1: DEVICE LABEL HUMAN FACTOR & USABILITY TESTING

  • Defining human factor hazards in labels
  • HFE in label risk management strategies
  • Application of label usability testing & validation
  • Point of Care human factor testing specifics
  • Clarification of FDA expectations

Elijah Wreh, Regulatory Affairs Manager, Pre-Market, INVACARE

2:15 PART 2: FDA ACCEPTANCE OF STANDALONE SYMBOLS IN LABELING

  • Clarifying the June 2016 new rule
  • Review of FDA-approved standalone symbols
  • Mandatory symbol glossary & content requirements
  • Efforts in harmonizing US & OUS symbol use

Roger Peterson, Manager, Global Labeling Systems, ARTHREX

 

3:00 COFFEE & NETWORKING BREAK

CHOOSE A TRACK:

3:30 TRANSLATION TRACK
Chairperson: Shannon Rose Farrell, Senior VP, Global Sales & Life Science Strategy
ARGOS MUTILINGUAL

PRACTICAL CASE STUDIES – OPTIMIZATION OF TRANSLATION STRATEGY & WORKFLOW BIOFIRE DIAGNOSTICS CASE STUDY:

  • Translation expansion: 5 languages in 2012 to 22 in 2016
  • Early attempts at building translation workflow & lessons learned
  • Practical approach to avoiding translation & localization pitfalls
  • Building a flexible & scalable translation & localization process
  • Focus on building a relationship with the in-country review board

Monica Wilcox, Country Entry Program Manager, BIOFIRE DIAGNOSTICS

 

4:15 FRESENIUS KABI CASE STUDY

  • In-house translation workflow organizational structure
  • Use of standards & tools:
    • ISO 17100:2015
    • Translation management system
  • Means of expediting the label return time
  • Successful management of in-country reviews

Andrea Schneiderman, Project Leader, Operator’s Manuals & Labeling
FRESENIUS KABI, USA

 

5:00 BECKMAN DIAGNOSTICS CASE STUDY:

  • Genesis of translation workflow
    • Document-based to component content management
  • The importance of terminology control
  • Automated LQA – reaping the benefits of organizational standards
  • Quality metrics – definition and verification
  • Controlling translation holistically: Software to IFU

Dan Koenig, Global Translation Services, BECKMAN COULTER

3:30 UDI TRACK:
CHAIRPERSON:
Ardi Batmanghelidj, President, INNOVATUM

INTEGRATION OF INTERNATIONAL REQUIREMENTS IN UDI STRATEGY

  • UDI & traceability rules outside of the USA
  • IT features enabling regulatory management
  • Amending UDI strategies to integrate international rules
  • Aligning the UDI process in global corporations

Thomas Denaro, Dir. Corporate Regulatory Global Systems, Corporate/Shared Services
BD

 

4:15 OVERCOMING COMMON UDI BARCODE CHALLENGES

  • Defining quality & good VS poor barcodes
  • Software design enabling barcode reading
  • Barcode verification & FDA inspection

Greg Bylo, VP Healthcare, GS1 US

 

5:00 PREPARING FOR DIRECT MARKING COMPLIANCE

  • Product-specific means of direct marking:
    • RFID
    • Laser-etching
  • Validating efficiency & cleanness of marking
  • Multiple testing for global product lines

Seana Hurd, Senior Director Quality Sys. & Technical Documentation, UDI Program Manager
INTUITIVE SURGICAL

5:45 CLOSING REMARKS & DAY 1 CONCLUSION