DAY TWO | THURSDAY, JANUARY 23
8:30 REGISTRATION & WELCOME COFFEE
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
9:45-12:30 EU MDR COMPLIANCE MODULE: ENSURING OPERATIONAL READINESS FOR IMPLEMENTATION DEADLINE
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.
9:45 INDUSTRY CASE STUDY: PREPARATION STRATEGIES FOR OPERATIONAL COMPLIANCE
- Gap analysis to determine areas of non-compliance
- Outlining process for vigilance reporting
- Templates of required reporting documents
Gary Chung, Associate Director, Surveillance Data Sciences, JOHNSON AND JOHNSON
10:30 COFFEE AND NETWORKING BREAK
11:00 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
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 – Karen Rittle Leigh, PhD, International Regulatory Manager
3M 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, Senior Director, Global Quality Analytics, Digital Systems & Data Governance, INTEGRA LIFE SCIENCES
Sabyasachi Roy, PhD, Director, Regulatory Affairs, Quality Assurance & Compliance, BRAINSCOPE COMPANY, INC.
David Scott, CISSP-ISSEP, CRISC, Associate Director, Medication Management Solutions, BD
Weiping Zhong, Global Director, QA/RA Risk Management, Clinical Evaluation, Cybersecurity Safety, Statistics
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 COFFEE AND NETWORKING BREAK
3:45 POSTMARKET STRATEGIES TO ENSURE UTILIZATION OF SEAMLESS RECALL MANAGEMENT PROCEDURES
As medical devices continue to advance in complexity, the possibility for malfunctions or quality deficiencies equally rises, it is the responsibility of postmarket teams remain vigilant in discovering any large scale product problems that might result in recalls. While the recalls involve a multitude of internal executives, the collaboration between all teams involved is critical to ensuring seamless and swift recall management strategies are employed. Postmarket teams are often engaged in pre-recall operations and it is critical for executives to utilize compliant and efficient processes to ensure timely reporting and execution of product recalls in order to mitigate any potential future adverse events.
- Risk assessments for initiating full recall actions
- Transitioning from small corrective actions to full recalls
- Compliance guidelines for recall reporting requirements
Joe Falvo, Senior Manager, Post Market Risk Management, ORTHO-CLINICAL DIAGNOSTICS
4:30 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
5:00 END OF CONFERENCE