DAY ONE | WEDNESDAY, JANUARY 22

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 OPENING ICE BREAKER: DEVICE POSTMARKET SURVEILLANCE OPERATIONS FOR EXECUTIVE LEVEL AUDIENCE
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the daily challenges of executive level audiences, discussing challenges associated with preparation strategies for compliance with EU MDR regulations, best practices in data gathering from social media sources, and the impact of technological advancements on adverse event data collection. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts.

 

9:30 PANEL DISCUSSION: NAVIGATING THE EVOLUTION OF THE POSTMARKET SURVEILLANCE ROLE

  • Impact of increased regulatory expectations of surveillance teams
  • Artificial intelligence and technological advancements in data quality
    • Implications on data sourcing
    • Enriched data analyses
  • Postmarket real world evidence as a strategic priority for submissions

John Giantsidis, Senior Director, Global Quality Analytics, Digital Systems & Data Governance, INTEGRA LIFE SCIENCES

Joe Falvo, Senior Manager, Post Market Risk Management, ORTHO-CLINICAL DIAGNOSTICS

Sabyasachi Roy, PhD, Director, Regulatory Affairs, Quality Assurance & Compliance, BRAINSCOPE COMPANY, INC.

Lawrence Peruzza, Director, Product Quality Vigilance – Combination Products NA/LATAM, JANSSEN

Robert Steele, EVP Regulatory and Clinical Affairs, CONVATEC

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 INTERNAL OPERATIONAL CONSIDERATIONS FOR STREAMLINED COMPLAINT ESCALATION
Postmarket surveillance at its foundation begins with the discovery of adverse events, which manufacturers are often made aware of from healthcare providers and patients through interactions with internal complaint centers. Once a complaint has been logged into the organization’s database, complaint analysts must determine the appropriate next step to instigate ranging from simply logging the callers information through to escalating the complaint for further evaluation. The success of any postmarket surveillance program hinges on instituting processes early in the complaint handling process so all analysts and postmarket teams are aware of the organizations’ escalation criteria to ensure critical errors are proactively corrected.

  • Outlining criteria to consideration for complaint escalation
  • Stakeholders involved in the development of escalation plans
  • Escalation criteria training strategies for call center representatives

Robert Steele, EVP Regulatory and Clinical Affairs, CONVATEC

 

11:45 DRIVING PRODUCT IMPROVEMENT THROUGH THE USE OF POSTMARKET SURVEILLANCE INSIGHTS
The overarching goal for all medical device manufacturers is to create a robust and profitable product portfolio and the foundation of reaching this target is to continually develop quality products. As organizations look to expand product lines, looking at outcomes and postmarket surveillance feedback from earlier existing medical devices offers a great opportunity to proactively address gaps in long-term quality. The insights and analytics from currently marketed products can offer not only product-specific information, but enables manufacturers to potentially mitigate long-term design inconsistencies, manufacturing non-compliances which assist in the production of safe and effective product lines.

  • Constructing analyses to generate insightful actionable data
  • Communication of insights to appropriate product stakeholders
  • Postmarket analyses: Pull through strategies for new R&D projects

Michael Hopkinson, QA Leader, GE HEALTHCARE

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 – 3:00 IMPACT OF MDSAP MODEL ON RISK BASED PRODUCT SAFETY MONITORING

  • Navigating the three round audit process for MDSAP certifications
  • Building foundational plan for an auditing organization review
  • Tailoring MDSAP postmarket plans for regional requirements
  • Internal gap analyses and monitoring post-MDSAP certification

 

1:45 LEGAL PERSPECTIVE
Brady Mickelsen, Associate, SIDLEY AUSTIN LLP

 

2:15 INDUSTRY PERSPECTIVE
Paul Chiappetta, Director of Quality Systems, THERMO FISCHER SCIENTIFIC

 

3:00 COFFEE AND NETWORKING BREAK

 

3:30 RISK ASSESSMENTS FOR PARTICIPATION WITH FDA VOLUNTARY MANUFACTURING SUMMARY REPORTING

  • Internal risk assessment regarding voluntary reporting
  • Benchmarks triggering need for adverse event data submission
  • Compliance parameters for participation with FDA VMSR program
  • Overview of experience and results from VMSR involvement

Rachael Hunt, Associate, HYMAN, PHELPS & MCNAMARA

 

4:15 SMALL GROUP DISCUSSIONS: GARNERING POSTMARKET AND ADVERSE EVENT DATA FROM SOCIAL MEDIA SOURCES
The world of social media and digital engagement offers HCPs and patients an environment to openly engage in conversation regarding medical devices; however, this open communication offers postmarket surveillance teams a variety of challenges in monitoring and data verification. In order to engage in meaningful, in-depth conversations regarding the complex nature of the sourcing and analyzing digital and social media for postmarket relevant product information, attendees will break into small groups to engage in peer to peer discussion. Facilitated by a discussion leader, participants will share recent experiences regarding which social medical platforms are monitored and how to best determine what comments are online noise compared to viable and reportable events.

Sandra Bausback-Aballo, Director, Post Market Surveillance, BOSTON SCIENTIFIC

Ladi Owolabi, Deputy Director, Medical Device Safety, BAYER

 

5:00 END OF DAY ONE CONFERENCE

Share This