DAY ONE | TUESDAY, MAY 14TH
7:00 REGISTRATION & WELCOME COFFEE
7:45 CHAIRPERSON’S OPENING REMARKS
8:00 OPENING 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, and engage in discussion. Given the challenge of continuously remaining abreast of evolving rules for labeling in the US and abroad, having the unique opportunity to directly share knowledge and experience pertinent to new provisions among peers is of the highest value. Furthermore, participants in this warm-up session will not only gain critical insight into important requirements that might have been overlooked, but also build contacts with industry peers, kicking off the event networking platform.
Lynne Kenison, HOLOGIC
Patrice Wright, JOHNSON & JOHNSON
8:15 OPTIMIZING REGULATORY LABELING MANAGEMENT IN LIGHT OF CONTINUOUSLY EVOLVING REQUIREMENTS
- Regulatory intelligence collection methods
- Mastering steps towards integration:
- Interpretation of new provisions
- In-country review & internal approval
- Documenting in a traceable manner
- Use of requirements management software
Joyce Trese, UDI Project Lead, ROCHE
MASTERCLASS: IN-DEPTH ANALYSIS OF THE EU MDR & IVDR IMPACT ON LABELING OPERATIONS
9:00 INTERVIEW: CLARIFYING SPECIFIC AREAS OF CONCERN WITH NOTIFIED BODIES
The EU MDR and IVDR have a significant impact on labeling operations with the introduction of provisions pertinent to symbols, enhanced language requirements, increased IFU content, and new documentation pieces such as the patient leaflet and implant card. In order to fulfill compliance in a timely manner, labeling teams require greater and more precise insight into areas of ambiguity, notably in the interpretation of unclear provisions and how to prepare strategies when critical platforms such as EUDAMED remain to be implemented. In the effort to shed light into the most prominent and timely challenges for labeling teams, notified body representatives will answer questions directly submitted by participants ahead of the conference.
Kathleen Crowder, BAXTER INTERNATIONAL INC.
Vipul Rapore, TUV SUD
Haijuan (Jane) Li, DEKRA CERTIFICATION, INC.
9:45 COFFEE & NETWORKING BREAK
10:15 CASE STUDY – MANAGING UPDATES IN EU MDR/IVDR REGULATORY LABELING STRATEGIES
With a large number of new provisions to integrate into regulatory labeling strategies in a short period of time, device and diagnostic manufacturers of all classes are currently at differing levels of advancement in the transition towards new EU requirements. Many labeling professionals are in search for detailed insight into other teams’ journeys towards achieving MDR and IVDR readiness, with a special focus on steps already taken, those still necessary to complete, and how labeling leaders are organizing remaining operations to reach the deadline. Gaining insight into peers’ experience’s in establishing and implementing MDR or IVDR compliance thus far is critical to regulatory teams in the effort of developing benchmarks for proactivity and overcoming challenges.
CASE STUDY 1: Mercedes Bayani, Global Director, Regulatory Affairs, BIONESS
11:15 INTRICACIES OF EUDAMED: WHAT IT IS, WHAT WILL BE EXPECTED AND HOW TO DELIVER
- Status of EUDAMED & similarities to GUDID
- Basic UDI-DI as key identifier of devices
- Various data elements and formats
- Navigating EUDAMED submission process
- Gateway and protocols of relevance
- Role of other Economic Operators
Ardi Batmanghelidj, President & CEO, INNOVATUM, INC.
12:00 MDR & IVDR-SPECIFIC EXCHANGE GROUPS: SHARING INSIGHTS INTO EU REGULATORY STRATEGY REMEDIATION
With divergent transition periods, respectively 3 years for medical device manufacturers and 5 for IVD, labeling professionals currently seek detailed information relevant to managing regulatory revisions for each industry. In addition, certain areas of compliance contrast between both sets of rules, such as the level and nature of details to include in label materials per product class, adding to the increasing need to focus on distinct provisions within each field. Through a highly interactive discussion format, participants are given the opportunity to engage directly with peers from the same industry and dive deeper into common challenges, all while brainstorming potential remediation strategies.
Bruce Edwards, ALCON
Kathleen Crowder, BAXTER INTERNATIONAL, INC.
Tanya Klaslo, BECTON DICKINSON
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 CASE STUDY: ANALYSIS OF RECENT LABELING REQUIREMENTS – FOCUS ON CHINA
With the continuous release of new regulatory requirements on an international level, professionals strive for access to timely insight into provisions which impact labeling operations. The Chinese market is of particular interest, as new rules have recently been issued and will require revisions to current labeling regulatory strategies. Participants in this session have the opportunity to explore practical approaches to strategy updating and best practices to meet compliance with evolving regulations in the Chinese market.
Mercedes Bayani, Global Director, Regulatory Affairs, BIONESS
2:00 IN-COUNTRY REVIEW PROCESS AS A CRITICAL PATH FOR GLOBAL PRODUCT RELEASE AND A PARADIGM SHIFT
In-Country Review, often, becomes a bottleneck in the localization process delaying the return time of the translated labels and time to market. Although not imposed by regulations, in-country review is considered as best practice amongst medical device and IVD manufacturers as one way to comply with regulatory requirements for the provision of accurate localized content. This presentation will discuss best practices from varied life science companies where in-country review has expedited time to market, with a focus on:
- Varied methods of resource allocation
- File formats: PDF-based or tool-supported
- Full content review vs. partial vs. no ICR
- Integration of ICR into localized launch
Michael Oettli, Managing Director, NEXT LEVEL GLOBALIZATION
Nana Lachanidou, Director Supplier Services, NEXT LEVEL GLOBALIZATION
2:45 PANEL: REACHING SUCCESS IN PARTNERSHIPS WITH TRANSLATION PROVIDERS
- Vendor selection criteria: quality & compliance
- Aligning on delivery timeline expectations
- Addressing in-country review challenges
- Ensuring translation return on investment
Nancy Kellen, IDEM TRANSLATIONS, INC.
Anita Stever, ACIST MEDICAL SYSTEMS
Sara Brouillette, BIOMERIEUX
Patrice Wright, JOHNSON & JOHNSON
3:30 COFFEE & NETWORKING BREAK
4:00 DECIPHERING COMPLIANT USE OF SYMBOLS IN MEDICAL TECHNOLOGY LABELING
In the effort of developing label artwork reflective of market-specific requirements, teams are currently aiming to shed light into ongoing grey areas in national and particularly international provisions pertinent to symbols. As a timely example, the EU MDR and IVDR are in the industry’s spotlight with unclear mandates focused on medical device or IVD identification via specific symbols that remain undefined, for which many raise concerns in the overall acceptance from authorities of a manufacturer-developed symbol. With an increase in similar challenges on the international level, labeling and regulatory teams strive for a deeper understanding of the establishment of internationally harmonized symbols through ISOs, as well as a practical approach to the proper development of company-specific symbols and how to compliantly implement a legend in associated documentation.
- Clarifying grey areas in EU MDR/IVDR symbol requirements
- Review of international mandates impacting label symbols
- Maximizing ISO15223:2016 for international compliance
- Compliant association of text & symbols in labeling materials
Roger Peterson, Manager, Global Labeling Systems, ARTHREX
4:45 PANEL: STRATEGIZING FOR SUCCESSFUL IFU DEVELOPMENT & CONTENT MANAGEMENT
In order for instructions for use to efficiently convey critical safety information to end-users across the globe, the goal must always be to maximize attention to details in all sections composing the document. It is therefore imperative for labeling teams to meet diverse regulatory requirements, all while ensuring content accuracy and intelligibility for diverse potential users. To this end, certain challenges including taking into account human factor needs, and formulating a comprehensive and market-relevant symbol glossary pose more difficulties than others to labeling professionals. With the intent to establish IFU development process optimization, manage content appropriately, and support leading edge production, it is essential for labeling teams to fully comprehend the overall IFU strategy workflow and how to best structure a successful process.
- Addressing human factor complexities
- Employing end-user accessible language
- Symbol & glossary inclusion challenges
- Content validation & continuous management
Shital Bhammar, HOLOGIC
Jennifer Sturr, ACCURAY
Karen Waterfield, ACIST MEDICAL SYSTEMS
5:30 CLOSING REMARKS & DAY 1 CONCLUSION
6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on May 14th. Please note that dinner expenses must be covered by each participant individually.