3rd Annual
EU Medical Device Post-Market Clinical Evaluation Planning Conference
April 19-20, 2023 | Paris, France
3rd Annual
EU Medical Device Post-Market Clinical Evaluation Planning Conference
April 19-20, 2023
Paris, France
Successfully Identifying & Filling Clinical Evidence Gaps to Promptly Fulfill MDR PMCF Requirements, Diving Deeper into Notified Body Expectations in Data Quality & Quantity, all while Overcoming Challenges with Data Scarcity for WET
Notified Body Speakers:
Marianna Mastroroberto
Internal Clinical Expert
KIWA CERMET ITALIA
Tonia Jeiter
Clinical Reviewer
TUV SUD
Clinical Regulatory Lead
BSI
Industry Experts:
Bassil Akra
CEO
AKRA TEAM
Nathalie Trétout
Clinical Affairs Manager
MENIX
Francisco Aránega
Partner
AMyS LAW
Carine Cochereau
VP International Regulatory Affairs
INTEGRA LIFE SCIENCES
Investigation Task Force
MEDTECH EUROPE
Michal Slomczykowski
Medical Director
GEISTLICH PHARMA
Benedikt Sigurjónsson
Manager of Clinical Evaluation, Medical Office
ÖSSUR
Cecile van der Heijden
Senior Attorney-at-Law
AXON LAWYERS
Torsten Böhler
Clinical Program Manager
BD
Karen Matthews
Business Development Manager
NIHR CLINICAL RESEARCH NETWORK
Business Development Manager
NIHR CLINICAL RESEARCH NETWORK
Leo Hovestadt
Director Government Affairs EU
ELEKTA
Sarah Panten
Co-Founder & Speaker of the Board
MEDICAL DEVICE KNOWLEDGE UNITS (MDKU)
Marcus Torr
PMCF/MDR Lead
PURDIE PASCOE
Peter O’Blenis
CEO
DISTILLERSR
Jón Ingi Bergsteinsson
Founder
SMART-TRIAL by Greenlight Guru
Erik Vollebregt
Partner
AXON LAWYERS
Valya Ramakrishnan
Regulatory Affairs Compliance Manager- Clinical Evidence & Evaluation
PHILIPS
Severin Fürhapter
Head of Hearing Science & Clinical Research
MED-EL
Olga Gusyatiner
Clinical Research & Evaluation Manager
YPSOMED
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
Torsten Böhler, Clinical Program Manager
BD
9:00 UNVEILING A SPECIFIC APPROACH TO POST-MARKET DATA GENERATION
• Strategy selection criteria amongst the multiplicity of options
• Integrated PMCF within the PMS plan to maximize data generation
• Practical insight into the planning & execution of the methodology
• Lessons learned through encountered pitfalls & course-correction
Leo Hovestadt, Director Government Affairs EU
ELEKTA
9:45 EXAMINING SOLUTIONS TO OPTIMIZED SURVEY STRUCTURES & RESULTS
• Delineating the frontier between PMCF & marketing surveys
• Adequate structure to avoid falling into marketing realm
• Architectural considerations enabling targeted data generation
• Incorporating ISO 14155:2020 features to guarantee receivability
Torsten Böhler, Clinical Program Manager
BD
10:30 COFFEE & NETWORKING BREAK
11:00 PANEL DISCUSSION: WEIGHING PROS & CONS OF VARIOUS PMCF METHODOLOGIES
• Opportunities & limitations with surveys
• Challenges & successes with registry studies
• Unveiling further uncommon methodologies
• Practical tips in optimizing data generation results
MODERATOR:
Marcus Torr, PURDIE PASCOE
PANELISTS:
Benedikt Sigurjónsson, ÖSSUR
Michal Slomczykowski, GEISTLICH PHARMA
Torsten Böhler, BD
11:45 COLLECTING PROACTIVE PROSPECTIVE CLINICAL DATA WITH A FOCUS ON USABILITY
• Exploring alternatives to a traditional clinical investigation
• Ad-hoc data collection & how to use it for PMCF
• Methods to motivate end-users to provide necessary data
Jón Ingi Bergsteinsson, Founder
SMART-TRIAL by Greenlight Guru
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30 WORKSHOP: MASTERING THE DEVELOPMENT OF A COMPLIANT PMCF PLAN FOR LEGACY DEVICES
• Conducting a through clinical data gap assessment
• Key elements & procedures to include in the PMCF plan
• Proper data sourcing to fit needs & NB expectations
• Team management considerations to achieve success
Bassil Akra, CEO
AKRA TEAM
Erik Vollebregt, Partner
AXON LAWYERS
2:45 CHALLENGES & OPPORTUNITIES FOR MEDICAL DEVICE COMPANIES CONDUCTING POST-MARKET SURVEILLANCE AS PART OF THE COMPLIANCE PATH
• Understanding the relationship between risk, PMS requirements & performance evaluation
• Leveraging transparency & compliance for literature reviews in the PMS context
• Employing automation & smart workflows to effectively monitor clinical literature & databases
• Implementing best practices for literature reviews supporting a PMS quality management system
• Considering operational efficiencies to streamline data gathering & analysis
MODERATOR: Bassil Akra, AKRA TEAM
PANELISTS: Peter O’Blenis, DISTILLERSR
Severin Fürhapter, MED-EL
Michal Slomczykowski, GEISTLICH PHARMA
3:30 COFFEE & NETWORKING BREAK
4:00 OVERCOMING CHALLENGES IN DATA IDENTIFICATION & GENERATION FOR LOWER-RISK LEGACY DEVICES
• Addressing data scarcity for WET class I, IIa devices
• Challenges in producing sufficient benefit/risk data
• Opportunities in data generated outside of the EU
• Solutions to expedite post-market data requirements
Valya Ramakrishnan, Regulatory Affairs Compliance Manager- Clinical Evidence & Evaluation
PHILIPS
4:45 HIGHLIGHT OF COMPLIANT STRATEGIES TO ENGAGE HCPS IN WET STUDIES
• Legal perspective into:
» HCPs’ obligations with WET studies
» Simplified data collection structures
• Considering compliant incentives to prompt participation
• Common contracting pitfalls versus successful approaches
Francisco Aránega, Partner
AMyS LAW
5:15 SMALL GROUP DISCUSSIONS: EXCHANGE OF EXPERIENCE IN CEP & PMCF COMPLIANCE BY COMPANY SIZE
Given the differences in team structures, as well as available time and budget to allocate to developing and executing clinical evaluation plans and post-market clinical follow-up, this small group discussion format enables participants to join other delegates from similar company sizes to share knowledge, challenges and solutions pertinent to distinct organizations.
GROUP 1: Small (> 50)
Nathalie Trétout, Clinical Affairs Manager
MENIX
GROUP 2: Medium (< 50 to > 200)
Olga Gusyatiner, Clinical Research & Evaluation Manager
YPSOMED
GROUP 3: Large (< 200)
Benedikt Sigurjónsson, Manager of Clinical Evaluation, Medical Office
ÖSSUR
5:45 Closing Remarks & End of Day 1
Day Two Agenda
Thursday, April 20
8:00 REGISTRATION & WELCOME COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
Peter O’Blenis, CEO
DISTILLERSR
8:30 ESTABLISHING & MAINTAINING A COMPREHENSIVE CLINICAL DATA MANAGEMENT SYSTEM
• Addressing the influx of clinical data to capture & manage
• Software tools & system architecture considerations
• Post-market data reporting & potential for automation
• Continuously maintaining & expanding the system
Sarah Panten, Co-Founder & Speaker of the Board
MEDICAL DEVICE KNOWLEDGE UNITS (MDKU)
9:15 OPTIMIZING THE UK AS A LOCATION FOR POST-MARKETING SURVEILLANCE & REAL WORLD EVIDENCE STUDIES
• Planning for success: Understanding the UK environment& ensuring deliverability
• Placing the study strategically& benefiting from nationwide systems to identify ideal sites
• Tapping into existing UK data sources
• Dive into current case study examples
Karen Matthews, Business Development Manager
NIHR CLINICAL RESEARCH NETWORK
Emanuela Mariani, Business Development Manager
NIHR CLINICAL RESEARCH NETWORK
10:00 COFFEE & NETWORKING BREAK
10:30 CREATING EFFICIENCIES VIA ROBUST COMMUNICATION & COLLABORATION WITH REGULATORY AFFAIRS
• Ensuring roles & responsibilities are clearly defined within each team
• Communication stream to convey regulatory intelligence to clinical
• Expediting report development & remediation in light of NB review
• Combining efforts to avoid redundancies in distinct teams’ tasks
Carine Cochereau, VP International Regulatory Affairs
INTEGRA LIFE SCIENCES
MDR CERTIFICATION STORIES: LESSONS APPLICABLE TO CEP & PMCF DEVELOPMENT
• Practical insight into the clinical evaluation plan development
• Communication with authorities pre & post submission
• Potential course-correction & lessons from the initial exchange
• Importance of the PMCF plan rationale in obtaining certification
11:00 CASE STUDY 1:
Nathalie Trétout, Clinical Affairs Manager
MENIX
11:45 CASE STUDY 2:
Severin Fürhapter, Head of Hearing Science & Clinical Research
MED-EL
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30 INTERVIEW: SHEDDING LIGHT ON NOTIFIED BODY PERSPECTIVES & EXPECTATIONS
With ongoing areas of uncertainty in post-market clinical evaluation plan development and data acceptability, as well as differing perspectives from one body to the next, clinical affairs professionals are given the unique opportunity to address questions to notified body speakers to receive transparent feedback, providing clarity into concerns of critical and timely importance.
INTERVIEWEES:
Adam Liddle, Clinical Regulatory Lead
BSI
Tonia Jeiter, Clinical Reviewer
TUV SUD
Marianna Mastroroberto, Internal Clinical Expert
KIWA CERMET ITALIA
INTERVIEWER:
Leo Hovestadt, Director Government Affairs EU
ELEKTA
2:15 DEEP DIVE INTO CLAIMS, MARKETING, ARTICLE 7 MDR & PMCF
• Impact of article 7 MDR on claims & claims maintenance
• Judiciously fitting article 7 MDR in an accurate PMCF plan
• Considering the influence of PMCF data on (marketing) claims
• Keeping claims, PMCF & clinical evaluation processes consistent
Erik Vollebregt, Partner
AXON LAWYERS
3:00 DISSECTING EVOLVING RULES FOR COMPLIANT PERSONAL DATA COLLECTION
• Data Governance Act & EU Health Data Space clarification
• Continuous focus GDPR & common areas of confusion
• Impact on post-market clinical data generation & gathering
• Enabling compliant operations within the legal framework
Cecile van der Heijden, Senior Attorney-at-Law
AXON LAWYERS
3:45 Closing Remarks & Conference Conclusion
Previous Attendees Include:
Director Regulatory & Clinical Affairs Europe, ABIOMED
Head of Clinical Operations, ABOCA
Sr Manager of Regulatory & Clinical Affairs, ADVANCED BIONICS
Clinical Project Manager, ANGIOMED
Supervisor R&D – Clinical Research, ARTHREX
Manager of Clinical Development, B. BRAUN MEDICAL
Head, Clin. Science & Regulatory Clin. Evaluation, BIOTRONIK
Director of Clinical Operations, BOSTON SCIENTIFIC
Senior Clinical Trial Manager, BOSTON SCIENTIFIC
Clinical Research Scientist, BRAINLAB
Quality Regulatory Affairs Manager, CARDINAL HEALTH
Clinical Project Management, Team Leader, COCHLEAR
Director Medical Affairs, COOK MEDICAL
Regulatory Affairs Manager, COOK MEDICAL
Clinical Expert, DEKRA CERTIFICATION
VP Medical Device & Global Clinical Director, DEKRA CERTIF.
Chair, DUTCH NORM COMMISSION ISO14155
Director Governmental Affairs EU, ELEKTA
Head of Clinical Trials, GEISTLICH PHARMA
Global Head of Medical Affairs & Clinical Development, GUERBET
Head of Clinical Affairs, HERAEUS MEDICAL
Director Clinical Trial Management EMEA, HOYA SURGICAL
Clinical Program Manager, Cardiac Surgery, LIVANOVA
Clinical Operations Manager, MAQUET GETINGE GROUP
Team Leader, CI Clinical Research, MED-EL
Senior Clinical Program Manager, MEDTRONIC
Principal Clinical Research Manager, NOBEL BIOCARE
Director of Medical Devices & Head of the Notified Body, NSAI
Manager of Clinical Evaluation, Medical Office, OSSUR
Senior Director Clinical Audiology & Research, OTICON MEDICAL
VP Clinical, Medical and Innovation, PETERS SURGICAL
Manager, Q&R Post-Market Surveillance, PHILIPS HEALTHCARE
Director, Clinical Assessment, TÜV SÜD
….And Many More
Who should attend:
Executives working within medical device manufacturing corporations that will find this program of greatest relevance are those currently working within clinical and/or regulatory functions, especially focused to meet compliance with the EU Medical Device Regulation’s requirements for post-market clinical activities.
• Clinical (Affairs, Research, Programs, etc.)
• Regulatory (Affairs, Compliance, etc.)
• Post-Market Clinical Follow-Up (PMCF)
• MDR Project Leads
• Post-Market Surveillance (PMS)
• Clinical Quality Assurance
