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6th Annual Medical Device Postmarket: Surveillance & Clinical Follow-up Conference

January 22-23, 2020 | Alexandria, VA

Hilton Alexandria Mark Center

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DAY TWO | THURSDAY, JANUARY 23

8:30 REGISTRATION & WELCOME COFFEE

SURVEILLANCE TRACK

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 LEVERAGING POSTMARKET CLINICAL FOLLOW UP STUDIES FOR DEVICE RECERTIFICATION
Following the conclusion of the MDR’s three year transition period which is rapidly approaching in Spring 2020, all new and re-certifications will be dictated by the MDR which includes increased requirements regarding clinical evaluation data. As the transition time comes to an end, manufacturers are analyzing product portfolios to determine areas of need in order to comply with the new clinical data rules and reviewing the impact of PMCF studies on legacy products. Through a case study driven presentation postmarket surveillance executives while be able to explore best practices and efficiency strategies to allow for manufacturers to proactively prepare to meet PMCF expectations.

  • Clarifying situations requiring PCMF studies
  • Elements for inclusion in PCMF study documents
  • Balancing of PMS and PMCF data guidelines

Dr. Delma Broussard, Director, Global Clinical Safety and Pharmacovigilance
CSL BEHRING

 

9:45 STRATEGIES FOR THE UTILIZATION OF LITERATURE REVIEWS TO GARNER POSTMARKET DATA
Literature reviews are a required component for a compliant postmarket surveillance plan; however, manufacturers are continually exploring avenues to streamline these operations to garner more viable data in a timelier manner while allowing for proper triaging and analyses of potential adverse event information that has been discovered. In an interactive workshop setting, the facilitator will provide small groups with specific scenarios highlighting different literature review scenarios for medical devices allowing executives to collaboratively create a proactive literature review plan and search framework. Groups will share experiences and learn how industry colleagues have managed similar situations in the past, allowing for valuable lessons learned and takeaways.

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

CLINICAL FOLLOW-UP TRACK

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 USE OF POSTMARKET, REAL WORLD DATA TO SUPPORT REIMBURSEMENT & MARKET ACCESS
As healthcare priorities continue to evolve towards a value based environment focused on lower costs coupled with higher quality outcomes, medical device manufacturers are being called upon to provide greater levels of real world evidence to support product access. The development of this data is of critical importance as device organizations look to stand out in an often crowded marketplace with numerous products of a similar use and is best gathered during postmarket phases where product utilization can be analyzed in a real world setting.

  • Aligning postmarket research with market access
  • Payer & provider outcomes data preferences
  • Methods for generating real world postmarket data
    • Randomized studies
    • Literature review
    • Patient registries
    • Direct surveys
  • Formulating data into actionable evidence dossiers

Avishek Mishra, Clinical Affairs Specialist, CANTEL MEDICAL

 

9:45 NOTIFIED BODY PERSPECTIVE: REGULATORY EXPECTATIONS FOR POSTMARKET MONITORING

  • Status of notified body designations under the EU MDR
  • Highlight changes to notified body product review operations
  • Perspective on trends regarding manufacturers’ compliance readiness

Eric Henning, Senior Project and Operations Manager, DEKRA

10:30 COFFEE & NETWORKING BREAK

11:00 NOTIFIED BODY PERSPECTIVE: REGULATORY EXPECTATIONS FOR POSTMARKET MONITORING
Since May 2017 when the EU MDR regulation was released, the medical device industry has been actively working to interpret the new compliance standards and alter internal processes to ensure uninterrupted compliance by the May 2020 deadline. With the deadline quickly approaching, manufacturers are in the final stages of implementing operational and process changes related to new reporting and data requirements. A critical change brought about from the EU MDR is the expectation that postmarket and complaint handling activities must be proactively based and postmarket teams are currently evaluating the nature of the organization’s postmarket operations to ensure processes tie back to a risk management based foundation.

  • Status of notified body designations under the EU MDR
  • Highlight changes to notified body product review operations
  • Perspective on trends regarding manufacturers’ compliance readiness

11:00 LEVERAGING POSTMARKET CLINICAL FOLLOW UP STUDIES FOR DEVICE RECERTIFICATION
Following the conclusion of the MDR’s three year transition period which is rapidly approaching in Spring 2020, all new and re-certifications will be dictated by the MDR which includes increased requirements regarding clinical evaluation data. As the transition time comes to an end, manufacturers are analyzing product portfolios to determine areas of need in order to comply with the new clinical data rules and reviewing the impact of PMCF studies on legacy products. Through a case study presentation, postmarket surveillance executives while be able to explore best practices and efficiency strategies to allow for manufacturers to proactively prepare to meet PMCF expectations.

  • Clarifying situations requiring PCMF studies
  • Elements for inclusion in PCMF study documents
  • Balancing of PMS and PMCF data guidelines

Dr. Delma Broussard, Director, Global Clinical Safety & Pharmacovigilance
CSL BEHRING

12:00 SMALL GROUP DISCUSSIONS: EU MDR COMPLIANCE BREAKDOWN
As preparation for aligning internal processes with the upcoming standards outlined within the EU MDR is not only very time consuming, but it effects a plethora of areas within the postmarket team. This group discussion allows attendees an opportunity to engage with industry colleagues regarding specific areas of the postmarket surveillance process that are impacted by changes in regulations to be better equipped to ensure compliance.

GROUP ONE: PSUR
Julie Taing, Sr. Manager, Global Post-Market Surveillance, AVANOS MEDICAL

GROUP TWO: TREND REPORTING
Luis Maldonnado, Customer Engagement Manager3M CRITICAL AND CHRONIC CARE DIVISION

 

12:45 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 PANEL DISCUSSION: IMPLICATIONS OF CYBERSECURITY INITIATIVES FOR POSTMARKET RISK MONITORING
Pre-market cybersecurity processes to decrease postmarket gaps
Challenges with postmarket cybersecurity for legacy devices
Communication and implementation of device software patching
Enforcement trends surrounding cybersecurity regulatory compliance

John Giantsidis, INTEGRA LIFE SCIENCES

David Scott, CISSP-ISSEP, CRISC, BD

Weiping Zhong, GE HEALTHCARE

 

2:45 SMALL GROUP DISCUSSION: GLOBAL REGULATORY POSTMARKET MONITORING EXPECTATIONS
Facilitated discussions will provide participants with an opportunity to delve into unique postmarket surveillance challenges associated with different global regulatory markets where complaint handling and post-market reporting are proving difficult, ensuring knowledge is gathered on areas of most concern.

GROUP ONE: CHINA

GROUP TWO: NORTH AMERICA

FACILITATOR:
Jacqui Budde, Quality Product Surveillance Director – MRI, GE HEALTHCARE

 

3:30 END OF CONFERENCE

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