5th Annual Medical Device Global Postmarket Surveillance Conference

January 30-31, 2019 | Arlington, VA

Hilton Crystal City at Washington Reagan National Airport

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DAY ONE | WEDNESDAY, JANUARY 30

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Kimberly Shelly, Post Market Surveillance Manager, Codman Specialty Surgical
INTEGRA LIFESCIENCES

9:00 OPENING ICE BREAKER: 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 project management hurdles, feedback from regulatory authority interactions, and complaint data escalation. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts.

 

9:30 PANEL DISCUSSION: CONTINUOUS MONITORING SOLUTIONS TO ENSURE UNINTERRUPTED SAFETY SURVEILLANCE

  • Balance of reactive vs. proactive process in continuous monitoring
  • Pros and cons of continuous and non-continuous safety operations
  • Reporting requirements when employing continuous monitoring
  • Responsibility division between complaints and postmarket teams

MODERATOR:
Tom Middleton, SPARTA SYSTEMS

PANELISTS:
Matthew Amaral, FRESENIUS MEDICAL CARE

Evgeniya Degnera, JOHNSON & JOHNSON

Jacqueline Koonce, MEDTRONIC

Kimberly Shelly, INTEGRA LIFESCIENCES

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00- 12:30 DATA ESCALATION MODULE: STRENGTHENING PRODUCT POSTMARKET ESCALATION PROCESS FOR MALFUNCTIONS
Medical device manufacturers are often inundated with large volumes of data related to the postmarket functionality of a product and postmarket teams’ key hurdle often lies with determining which data sources require further internal investigation and response. In an interactive workshop setting, the facilitator will provide small groups with specific scenarios showcasing common product complaint situations faced by medical device organizations during postmarket operations, and collaboratively discuss potential escalation considerations and tactics. Groups will share experiences and learn how industry colleagues have managed similar situations in the past, allowing for valuable lessons learned and takeaways.

11:00 OVERVIEW OF REPORTABLE MALFUNCTIONS
Stephanie Philbin, CounselGOODWIN PROCTER LLP

11:30 INTERACTIVE GROUP WORKSHOP
Matthew Amaral, Sr. Director, Postmarket Surveillance & Pharmacovigilance
FRESENIUS MEDICAL CARE

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

2:00 – 3:00 EU MDR MODULE: NAVIGATING THE IMPLICATIONS OF THE EU MDR ON POSTMARKET OPERATIONS
As the EU MDR deadlines approaching during the multiple year transition period, postmarket surveillance teams are concurrently converting products’ monitoring and reporting processes to align with the regulations requiring a more proactive approach. With a full regulatory implementation deadline of May 2020, manufacturers are still looking to discern the exact implications the more risk based regulation will have internally and also looking to notified bodies for further clarifications. While conversion to remain complaint with the EU MDR offers postmarket teams a multitude of challenges, this increase of proactive monitoring offers manufacturers the ability to offer uninterrupted product quality to patients.

2:00 NOTIFIED BODY PERSPECTIVE: NAVIGATING EU MDR IMPACT ON PM OPERATIONS
Matthias Fink, Clinical Reviewer, Clinical Centre of Excellence, TUV SUD AMERICA

2:45 ALCON CASE STUDY: IMPLEMENTATION STRATEGIES FOR ALIGNING WITH EU MDR EXPECTATIONS
Marcia Orozco, Associate Director, Sr. MDR Team Leader, ALCON

 

3:30 COFFEE AND NETWORKING BREAK

 

4:00 ADVANCING INTERNAL USE OF POSTMARKET DATA AND ANALYSES

  • Explore how data is currently utilized internally
  • Opportunities for enhancing external communications with postmarket data
    • Payer dossier
    • Regulatory submission updates
    • Marketing
    • Medical communications
  • Decoding internal teams that can benefit from postmarket analyses

Jamie Tobin, Senior Manager, Postmarket Surveillance, CEPHEID

 

4:45 COCKTAIL HOUR SPONSORED BY Q1 PRODUCTIONS

 

5:45 END OF DAY ONE CONFERENCE

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