11th Annual EU Medical Device Clinical Research Conference

March 21-22, 2019 | Berlin, Germany

Crowne Plaza Berlin Potsdamer Platz

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DAY ONE | THURSDAY MARCH 21

7:30 REGISTRATION & WELCOME COFFEE

8:00 CHAIRPERSON’S OPENING REMARKS
Adam Steadman, SYNEOS HEALTH

8:15 OPENING ICEBREAKER: SHARING PERSPECTIVES INTO THE IDEAL CLINICAL RESEARCH TEAM STRUCTURE
Kristine Klinger, LIVANOVA

8:45 KEYNOTE: INTEGRATION OF COMMERCIAL INSIGHTS INTO CLINICAL EVIDENCE PROGRAMS & VICE VERSA
Clinical Research Organizations traditionally operate in isolation from commercial teams, except when working in real world investigations. As a result, the focus of clinical trials is frequently on registration, rather than reimbursement and adoption. Optimizing the trial process can result in significant long-term savings, faster market access and optionality. Case studies illustrating the competitive advantage this provides will be presented in this session led by Syneos Health.

Adam Steadman, Vice President, Clinical Development, Business Unit Head, Medical Device & Diagnostics
SYNEOS HEALTH

 

9:30 UPDATE ON THE NB REDESIGNATION STATUS & IMPACT ON CLINICAL EVALUATION
With the ongoing designation period for notified bodies applying for accreditation against the MDR, and little time left to transition to the new regulation, the industry has continuous concerns surrounding clinical operations disruption in the Union. Clarification is currently needed on the status of the overall process, the number of bodies that have applied for certification and for which classes of devices, as well as the results of the first joint assessments.

Pedro Eerdmans, VP of Medical Business Line, DEKRA CERTIFICATION

 

10:00 PANEL: CLARIFYING NB PERSPECTIVES ON THE CURRENT APPROACH TO CLINICAL INVESTIGATION
In order for medical device clinical affairs teams to ensure compliance with the variety of recent requirements from European authorities including the MDR, it is critical to secure a clear understanding of notified bodies’ expectations. Much debate has been ongoing since the release of the regulation, focusing primarily on differing interpretations of appropriate clinical data sets to submit in both pre-and-post- market research, resulting in challenges for clinical executives in precisely defining data targets when developing studies. Further, concerns are raised with regards to misalignment of requirements in the overall development of clinical evaluation plan objectives, pressing for additional insight into the views of notified bodies.

  • Comparing key points in a robust clinical evaluation plan
  • MEDDEV & MDR: Potential for expectations alignment
  • Class-by-class approach to relevant & sufficient data
  • Focus on PMCF requirements & data acceptability

PANELISTS: Yvonne Ndefo – NSAI CERTIFICATION

Pedro Eerdmans – DEKRA CERTIFICATION

Bassil Akra – TÜV SÜD PRODUCT SERVICE

Itoro Udofia – UL INTERNATIONAL

 

10:45 COFFEE & NETWORKING BREAK

 

11:15 BREXIT & EXPECTED CHANGES TO CLINICAL RESEARCH IN THE UK

  • Impact on new & ongoing trials in the UK
  • Update on transition of UK-registered NBs
  • Clarifying changes to the regulatory framework

Giovanni Di Rienzo, Global Director, Cardiovascular Focus
TÜV SÜD PRODUCT SERVICE

 

11:45 EXCHANGE GROUPS: APPROACH TO EQUIVALENCE FOR CLASS IIa & IIb DEVICES
While demonstrating clinical equivalence has become very challenging for class III products within the MDR, due to the necessity of establishing a contract with the manufacturer of the similar device, classes IIa and IIb benefit from somewhat more leeway as the requirement only states having “sufficient” access to the competitor’s technical data. With the risk in equivalence refusal due to misinterpretation of unclear verbiage in the regulation, clinical teams working with IIa and IIb devices are in need of clarification regarding what can or not be done through the literature route. Through targeted discussions enabling direct peer-to-peer exchange, participants have the opportunity to further dive into the topic and debate perspectives, all while being led by a knowledgeable moderator to ultimately take away actionable insight.

CLASS IIa: Itoro Udofia, Head of Notified Body
UL INTERNATIONAL

CLASS IIb: Bassil Akra, VP Global Focus Teams, Active Impl.,
Cardiovascular, Orthopedic, Aesthetic & Clinical
TÜV SÜD PRODUCT SERVICE

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 ENHANCING THE INTEGRATION OF RISK MANAGEMENT IN CLINICAL TRIALS

  • Accurate risk/benefit analysis & risk assessment
  • Risks potentially impacting clinical objectives
  • Tolerance limits & appropriate risk responses
  • Opportunities & limitations with ISO 14971

Bijan Elahi, Corporate Director Risk Management, MEDTRONIC

 

2:15 WORKSHOP: DEVELOPING A COMPREHENSIVE TIMELINE & WORKFLOW ENCOMPASSING ALL NEW MDR REPORTS
Establishing a clinical evaluation plan that meets notified body and competent authority expectations is a central concern of clinical and regulatory teams working towards establishing an MDR-compliant strategy. With numerous provisions in the regulation including new reports, higher levels of data to collect, interpret and submit, as well as the need to organize teams efficiently, developing an actionable workflow proves complex. Through a practical workshop format, participants will be divided in small groups to undertake the challenge of designing a complete timeline and coordinate workflows by brainstorming and exchanging among peers.

Jessica Ward, Senior Clinical Affairs Manager, STRYKER

 

3:15 PRACTICAL INDUSTRY CASE STUDIES: MAXIMIZING THE USE OF THE REMAINING MDR TRANSITION TIME
With 14 months left to reach MDR compliance, clinical affairs and regulatory teams are actively working on updating policies to guarantee new provisions are efficiently integrated in clinical strategies, both on the pre-and-post-market levels. Currently, device manufacturers are at differing levels of advancement and face uncertainties regarding how to most efficiently organize remaining tasks. As each company structure is different, multiple approaches to transitioning to the new rules can be established, ultimately aiming towards a swift and cost-controlled shift towards MDR requirements.

  • Insight into achieved MDR transition tasks
  • Outlining remaining remediation actions
  • Human & financial resources considerations
  • Developing an objective & timely final plan

CASE STUDY 1: Alexandra Rieben, Global Lead Clinical Research & University Account Management
NOBEL BIOCARE SERVICES

 

3:45 COFFEE & NETWORKING BREAK

 

4:15 CASE STUDY 2

  • Adapting organizational structure to new needs
  • Clinical evaluations: A process, not a report
  • MDR data collection: Step-by-step planning

Basira Salehi, Senior Manager Clinical Science & Medical Affairs, BIOTRONIK

 

4:45 EXCHANGE GROUPS BY COMPANY SIZE: SECURING & MAXIMIZING CLINICAL BUDGETS

  • Determining financial & clinical staff needs
  • Increasing efficiency with less resources
  • Preparing for questions from hierarchy
  • Securing the budget with a safeguard

GROUP 1 – SMALL:
Hendrik Lambert, GTX MEDICAL

GROUP 2 – MID-SIZED:
Norbert Clemens, KANEKA PHARMA EUROPE

GROUP 3 – LARGE:
Kristine Klinger, LIVANOVA

Jana Meschede, BOSTON SCIENTIFIC

 

5:30 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on March 21st. Please note that dinner expenses must be covered by each participant individually.