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

Matthew Amaral, FRESENIUS MEDICAL CARE

Evgeniya Degnera, JOHNSON & JOHNSON

Maureen Uebelacker, BARD PERIPHERAL VASCULAR

Jacqueline Koonce, MEDTRONIC

Kimberly Shelly, INTEGRA LIFESCIENCES

Paula Rogalski, NXSTAGE MEDICAL

 

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, Counsel, GOODWIN PROCTOR LLP

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

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 – 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.

1:30 NOTIFIED BODY PERSPECTIVE: NAVIGATING EU MDR IMPACT ON PM OPERATIONS
Matthias Fink, Clinical Reviewer, Clinical Centre of Excellence, TUV SUD AMERICA

2:15 NOVARTIS CASE STUDY: IMPLEMENTATION STRATEGIES FOR ALIGNING WITH EU MDR EXPECTATIONS
Marcia Orozco, Associate Director, Sr. MDR Team Leader, NOVARTIS

 

3:15 COFFEE AND NETWORKING BREAK

 

3:45 SOCIAL MEDIA: DECODING VALID COMPLAINT DATA VS. ONLINE NOISE
Comprehensive postmarket surveillance and product safety reporting relies heavily on thorough and trusted data sources which can showcase a product’s efficacy or highlight potential deficits. In the past, postmarket teams have depended on adverse event reports from hospitals or physicians, medical literature reviews or patient complaints; however, the open-sharing atmosphere of social media has launched a new avenue of postmarket data for manufacturing organizations to utilize. Social media provides an un-restricted forum for medical device reviews, but the challenge facing postmarket executives when sourcing and collecting this data is what product mentions are relevant data versus what is strictly social media noise.

Jean Frydman, Of Counsel, BAKER DONELSON

 

4:30 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

 

5:15 END OF DAY ONE CONFERENCE

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We hope to see you at the conference!

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