A Special Thanks to Our Sponsors

Day One Agenda
Tuesday, September 16

8:00   REGISTRATION AND WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   POST-MARKET CLINICAL FOLLOW-UP (PMCF): BEST PRACTICES FOR ENSURING SAFETY AND EFFICACY OF DEVICES
• Assessing the requirements for developing a PMCF Plan
• Guidance to PMCF under the MDR 2017/745
• Strategies to quickly meet PMCF regulatory requirements
• Common mistakes to PMCF and best practices for resolutions
• Enhancing trust in the MD lifecycle through post-market activities
• Documentation and considerations to PMCF clinical investigations
Paula Searcy, Senior Director, PMCF Strategy
CLINQURE

9:30-11:00   SESSION SERIES: RISK MANAGEMENT, POST-MARKET SURVEILLANCE, AND CLINICAL EVALUATION
• Approaches to conducting a benefit-risk assessment
• Determining if a recall is needed and evaluating a strategy
• Best practices for documenting the benefit-risk assessment

9:30-10:15   PART ONE
Vishal Joshi, Senior Manager, Quality Engineering
BD LIFE SCIENCES
Olumide Opeke, Medical Safety Manager
QUIDELORTHO
Linda Braddon, President & CEO
SECURE BIOMED EVALUATIONS

10:15-11:00   PART TWO
Deepthi Badarinath, Senior Regulatory Affairs Specialist
FLUXERGY

11:00   COFFEE AND NETWORKING BREAK

11:30   CASE STUDY: ARTIFICIAL INTELLIGENCE BASED TOOLS AND USES FOR POST-MARKET SURVEILLANCE AND VIGILANCE
• Data analysis and pattern recognition
• Predictive analytics and risk assessment
• Automated report generation and early warning systems
• Real-time monitoring and active reportability monitoring
Jayet Moon, Quality Lead
TERUMO MEDICAL CORPORATION

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:15   LEVERAGING TECHNOLOGY TO ENHANCE POST-MARKET SURVEILLANCE STRATEGY
• Leverage tech to streamline operations and provide visibility
         » Data collection and analysis
         » Reporting and compliance
         » Enhancing safety
         » Regulatory considerations
• Defining the regulatory and quality system requirements
• Identifying the data sources of PMS and how to create actionable insights
Kandis Lattimore, Quality Manager, Post Market Surveillance
BD

2:00   FDA’S LEGAL AUTHORITY AND ENFORCEMENT ACTIONS IN THE POST MARKET ARENA
• FDA legal authority for post-market compliance
• Recent trends and recent FDA enforcement
         » Warning letters
         » Consent decrees
         » Quality system enforcement
• Promotion enforcement
         » Future direction for enforcement
Scott D. Danzis, Partner
COVINGTON & BURLING
Linda Braddon, President & CEO
SECURE BIOMED EVALUATIONS

2:45   COFFEE AND NETWORKING BREAK

3:15   PANEL DISCUSSION: EMERGING POST-MARKET SURVEILLANCE TRENDS IN FDA MEDICAL DEVICE ENFORCEMENT
• Increasing utilization of “non-traditional” enforcement tools for PMS
• Assessing the change in administration and what it means for the FDA
• Cybersecurity management and AI-enabled devices for PMS
• FDA’s PMS system for electronic health records and claims data
• FDA’s addressing of global harmonization and regulatory trends in PMS
Monica R. Chmielewski, Partner
Foley & Lardner LLP
Abeda Habtemariam, FDA Partner
ARNOLD & PORTER

4:00   FDA AND POST-MARKET OPERATIONS: METHODS TO STREAMLINE COMPLIANCE
• Understanding PMS requirements for the U.S.
• Overlaps and differences of FDA and EU MDR
         » Classification and risk assessment
         » Clinical data Requirements
• Strategies to streamline documentation for compliance
Jessica Ringel, Partner, FDA and Life Sciences
KING AND SPALDING

5:00   Closing Remarks and End of Day 1

Day Two Agenda
Wednesday, September 17

8:00   REGISTRATION AND WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   CONSIDERATIONS FOR ARTIFICIAL INTELLIGENCE SOFTWARE IN POST-MARKET SURVEILLANCE
• Assessing the various levels of implementation and integration
• Use of AI to categorize complaints for data analytics
• Leveraging automated processes in regulated environments
• Considering new technologies to detect quality issues
Philip Desjardins, Partner
ARNOLD & PORTER

9:15    PMCF OPTIONS FOR LEGACY DEVICES
• Overview of EU regulations and MDCG guidance
• Special routes available for legacy devices
• Well-Established Technologies (WET) considerations
• General and specific PMCF methods for legacy devices
Christopher Brodrick, Senior Product Reviewer, Orthopedic Devices SME
GMED NORTH AMERICA

10:00   COFFEE AND NETWORKING BREAK

10:30   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
Vallikannu Somasundaram, Senior Director, Quality Sciences
SENSEONICS

11:15   FDA INSIGHT: FDA GUIDANCE AND BEST PRACTICES FOR MANUFACTURERS AMID THE POST-MARKET SURVEILLANCE LANDSCAPE
• Assessing data from registries and claims addressing needs of stakeholders
• FDA guidance and perspectives relating to the following:
» Data collection and analysis
» Risk-Based Approach
» Integration with Quality Management System
» Compliance with Standards
• Questions and answers on the future of PMS safety and efficacy
Gregory Pappas, Associate Director Office of Biostatistics and Pharmacovigilance
FDA/CBER/OBPV

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:15   RISK MANAGEMENT AND THE HOLISTICALLY APPROACH OF SYNTHESIZING DATA WITHIN POST-MARKET OPERATIONS
• The difficulty in synthesizing data sets within different processes
• Timely action and good data collection for effective PMS
• The importance of synthesizing data to ensuring alignment with
» Specific processes within the QMS
» Various processes within the QMS
• Action steps to a comprehension and holistic approach for data collection
• The importance of synthesizing data holistically for PMS
Ronak Dunung, Senior Manager
PHILIPS

2:00   PANEL DISCUSSION: IMPLEMENTATION STRATEGIES FOR ALIGNING WITH EU MDR EXPECTATIONS
• Execution of the EU MDR four risk classes of medical devices
• EU MDR clinical data requirements on clinical evidence
• Execution of Periodic Safety Update Reports (PSURs)
• Execution of Post-Market Clinical Follow-up (PMCF) studies
Kandis Lattimore, Quality Manager, Post Market Surveillance
BD
Colleen Watson, Senior Director Regulatory Affairs, Clinical Diagnostics Division
THERMO FISHER SCIENTIFIC

2:45   COFFEE AND NETWORKING BREAK

3:15   NAVIGATING NOTIFIED BODY EXPECTATIONS: PROCEDURES AND SOLUTIONS FOR MANUFACTURERS
• Assessing the current EU MDR compliance landscape
• Notified bodies’ expectations and practical steps for direction
• Strategies for manufacturers to communicate with notified bodies
• Notified body perspectives on EU IVDR implementation
• PSUR preparation, notified bodies’ expectations, and feedback
Camilla Borrini, Associate Director, QARA PMO
ZIMMERBIOMET

4:00   COMPLAINT HANDLING REQUIREMENTS UNDER MDR AND IVDR
• Challenges and considerations pertaining to IVDR delays
• Strategies for notified bodies to simplify documentation
• Lessons learned to avoid jeopardizing regulations
Colleen Watson, Senior Director Regulatory Affairs, Clinical Diagnostics Division
THERMO FISHER SCIENTIFIC

4:45   Closing Remarks and End of Day 2