6TH SEMI-ANNUAL DEVICE AND DIAGNOSTIC LABELING CONFERENCE

April 27 – April 28, 2017 | ARLINGTON, VA
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DAY TWO | FRIDAY, APRIL 28

7:30 REGISTRATION & WELCOME COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS

8:00 CASE STUDY: PRACTICAL INSIGHT INTO LABELING PROCESS SET-UP & IMPROVEMENT
With the variety of device and diagnostic products developed each year, comes an equal number of potential labeling process structures to address specific market needs. Labeling professionals are continuously looking for strategies that will positively impact process flows and successful outcomes, in the effort of ensuring optimized operations all while decreasing timelines to label printing. This session will shed light into peers’ experience in planning, implementing and driving distinct labeling initiatives, with a focus on efficient process architectures and use of appropriate technology to expedite label development, manufacturing & validation.

  • Identifying & understanding the company need
  • Establishing a team of experts & clear responsibilities
  • Communicating the group’s existence to the organization
  • Becoming the subject matter experts

Aneta Waliszewski, Director of Quality Assurance
BIOFIRE DIAGNOSTICS

 

8:45 PANEL DISCUSSION: OPTIMIZING THE LABELING FUNCTION BY DRIVING AN ORGANIZATIONAL SHIFT
In device and diagnostic corporations, labeling holds an important place as it is an essential component of pre and post-market operations. Too often are labeling teams struggling to source the right data, standardize processes and deliver results in time due to common lack of proper positioning of the labeling function. With differing corporate structures and label prioritization efforts in all company sizes, labeling professionals are analyzing methods to re-structure overall workflows and make labeling more prominent to ensure efficiency.

  • Positioning labeling as an early-on priority
  • Structures to address significant labeling initiatives
  • Establishing centralized labeling control & function

Sarah Grare, Program Director, Global Labeling, STRYKER

Shital Bhammar, Supervisor, Product Labeling, HOLOGIC

Tammy Tortorici, Senior Manager, International Labeling Systems, ABBOTT DIAGNOSTICS

 

9:30 COFFEE & NETWORKING BREAK

 

10:00 BREAK-OUT SESSION: SHARING KNOWLEDGE & EXPERIENCE IN LABEL-SPECIFIC CHALLENGES
During this interactive session, executives will gather in small groups to discuss challenges in various areas of labeling development, data and compliance. This peer-to-peer learning environment, allowing for exchange of strategies and savvy tips will enable individuals to understand how other companies overcome similar hurdles through sharing of perspectives and real-life experience. Each topic will be moderated by a subject matter expert, who will report key findings to the rest of the audience at the end of the session, maximizing all participants’ number of take-home messages.

  • PROS & CONS OF SUBMITTING LABEL DATA IN XML FORMAT

Tim Smith, VP Service Solutions – Americas, nlg GmbH

  • EXPEDITING LABEL CHANGE MANAGEMENT & DOCUMENTATION

Tim Fischer, Sales Manager, PRISYM ID

  • DETERMINING IN-HOUSE DECISION RIGHTS ON LABEL CONTENT

Tammy Tortorici, Senior Manager, International Labeling Systems, ABBOTT DIAGNOSTICS

 

10:45 WORKSHOP: PRACTICAL APPROACH TO MASTERING LABEL FORMATS & REAL ESTATE ALLOCATION
Labeling and artwork design executives are continuously challenged with the overall amount of data necessary to fit in labels and instructions for use, typically of a small size. In order to ensure all important information is reported onto labeling materials with little available space, it is indispensable to gain a thorough understanding of which data is mandatory compared to data that is solely useful. Further, label real estate allocation must follow distinct rules for international markets, adding to the task’s complexity when requirements involve multiple languages. This interactive workshop will enable the audience to engage in a peer-to-peer learning format, by working on short assignments pertinent to label formats required by health authorities, as well as real estate allocation optimization and creative design. The audience will gather in small groups to brainstorm and share experiences to identify the best solutions to the proposed exercises, allowing for a maximum number of take-home messages.

Shital Bhammar, Supervisor, Product Labeling, HOLOGIC

 

11:30 INSIGHTS INTO R2D2 RESEARCH: FOCUS ON ELEMENTS IMPACTING HUMAN FACTOR INTEGRATION IN DEVICE IFUS
This interactive part-presentation, part-quiz session will shed light onto ongoing research led by UWM’s Rehabilitation Research Design & Disability “R2D2” Center. R2D2 performs interdisciplinary basic research investigations, applied research and development, as well as innovative instruction related to technology and disability, and has led many initiatives in patient population- specific IFU development incorporating direct feedback from patients with disabilities. With a strong focus on human factor integration in device IFUs, and the importance of clearly understanding the target patients’ needs, diving into R2D2 key findings and learnings will provide valuable comprehensive IFU development advice to labeling executives.

  • Understand perspectives of people with disabilities
  • Human factors in the design of device IFU’s
  • Impact of IFUs on medical device purchase & use decisions

Rochelle Mendonca, Research Fellow, R2D2
Assistant Professor, TEMPLE UNIVERSITY

 

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:15 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
  • Label usability testing & validation
  • Discussion of FDA expectations

Tina Rees, Associate Director, Human Factors, FERRING PHARMACEUTICALS

2:00 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

Lina Kontos, Counsel, HOGAN LOVELLS LLP

 

2:45 PRACTICAL KEYS TO A SUCCESSFUL ELABELING STRATEGY IMPLEMENTATION
With increasing corporate focus on sustainability and cost-saving opportunities, in addition to further international markets accepting elabeling each year, many organizations from the device and diagnostic industry are eager to learn more about implementing a fully electronic labeling strategy. Moving away from the paper route involves the use of appropriate technology and acquiring new IT skills, in addition to integrating specific elabeling regulatory requirements that differ from one market to another. The complexity of eIFU and related web portal development and management must also be taken into account in the overall electronic strategy development to ensure successful outcomes.

  • Elabeling rules review: US & OUS
  • Software capacities & relevant tools
  • Developing an eIFU & website
    • Key considerations
    • Getting IFUs online
  • Integration into existing business systems

Sarah Grare, Program Director, Global Labeling, STRYKER

 

3:30 CLOSING REMARKS & CONFERENCE CONCLUSION