EU Medical Device Post-Market Clinical Evaluation Planning Conference

October 29-30, 2019 | Frankfurt, Germany

Le Meridien Frankfurt Hotel

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DAY ONE | TUESDAY, OCTOBER 29

7:30 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Simon Crowe, Senior Business Development Manager, Medical Device Partnerships
CASTOR EDC

8:45 ICE BREAKER: SHARING PERSPECTIVES ON THE POSITIVE INFLUENCE OF ENHANCED POST-MARKET RESEARCH ON THE EU MEDICAL DEVICE MARKET
While the transition toward reinforced regulatory requirements for post-market clinical operations under the MDR challenges the industry, forward-looking executives also recognize a beneficial opportunity to improve product performance and value. By leveraging enhanced research, companies are positioned to reap numerous benefits including the ability to unveil real-world user experience data and design flaws in a more proactive and timely fashion, ultimately enabling prioritization of product improvements. This interactive ice breaker commences the event with an opportunity for all delegates to move around the conference room and engage in brief, targeted conversations with the goal of sharing specific insights into the exciting new developments in the medical device industry prompted by enhanced research requirements.

 

9:15 PANEL: NOTIFIED BODIES’ INTERPRETATION OF MDR-COMPLIANT POST-MARKET REQUIREMENTS

  • Factors in evaluating clinical evidence under the MDR
    • Outlining a satisfactory blend of data
    • Device maturity influence on NB review
    • Defining data amounts considered sufficient
  • Perspectives in critical components of a thorough PMCF plan
  • Addressing timely communication challenges with the industry

MODERATOR:
Basira Salehi, Head of Clinical Science & Regulatory Clinical Evaluation, BIOTRONIK

PANELISTS:
Caroline Dore Geraghty, Director of Medical Devices & Head of the Notified Body
NATIONAL STANDARDS AUTHORITY OF IRELAND

Pedro Eerdmans, Head of the Notified Body, DEKRA CERTIFICATION BV

Itoro Udofia, Medical Device Expert, Former Head of NB with UL
FORMERLY OF UL

Robert Madjno, Director, Clinical Assessment, TÜV SÜD

 

10:15 COFFEE & NETWORKING BREAK

 

IN-DEPTH STRATEGIZING TO DESIGN ACCURATE PMCF PLANS & DEVELOP SUFFICIENT CLINICAL EVIDENCE
One of the most urgent challenges facing professionals formulating plans for the collection of post-market clinical follow-up data lies in the lack of clear definition for sufficient clinical evidence in the EU MDR. While it is known that insufficient PMCF evidence will preclude a product from the market, over-straining organizational research budgets must also be prevented, and industry is therefore in need of insight into the minimum level of evidence considered acceptable by notified bodies and competent authorities. Companies seek to implement a mixture of active and passive data collection methodologies, typically dependent upon the device classification and maturity, and further complicated when multiple products must be planned for simultaneously.

 

10:45 PART 1 – PANEL: STRATEGIES TO ENSURE A BLEND OF DATA & ACHIEVE CLINICAL EVIDENCE EXPECTATIONS

  • Debating methods for clinical evidence generation & collection
    • Post-market interventional trials
    • Extension of pre-market trials
    • National health service registries
    • Physician & patient surveys
    • Purchasing of hospital data sets
    • Use of patient advocacy group data
  • Balancing incorporation of data from multiple sources
  • Positioning of unique data sets within the PMCF plan

MODERATOR: Barry Sands, RQMIS, INC.

Leo Hovestadt, ELEKTA

Norbert Clemens, KANEKA PHARMA EUROPE N.V.

Ela Bingel-Erlenmeyer, GEISTLICH PHARMA AG

Rita Herrenknecht, LIVANOVA

 

11:30 PART 2 – CASE STUDY: POST-MARKET RESEARCH PLANNING BASED ON PRODUCT MATURITY

  • Influence of device maturity on post-market research planning
  • Determining depth of evidence required for legacy devices
  • Practical application of post-market plans for legacy devices
  • Satisfying notified body scrutiny for new versus mature products

Leo Hovestadt, Director Governmental Affairs EU, ELEKTA

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 PART 3 – EXCHANGE GROUPS: DEFINING SUFFICIENT CLINICAL EVIDENCE BASED ON DEVICE CLASSIFICATION
While PMCF data requirements are enhanced for all families of devices under the MDR, the type and quantity of evidence considered satisfactory by notified bodies will vary based upon device risk classification. The new classification regime has altered the definition of risk inherent to the use of devices, creating challenges for clinical teams in planning for the generation and collection of relevant evidence, and ultimately, in how to design a comprehensive post-market evaluation plan. Delegates will have the opportunity to share challenges faced and solutions reached within specific device classes in an engaging discussion format led by a knowledgeable peer.

Group 1: Class I Devices
Benedikt Þorri Sigurjónsson, ÖSSUR

Group 2: Class IIa & IIb Non-Implantable Devices
Karsten Wallbrück, ABIOMED EUROPE GMBH

Group 3: Class IIb Implantable & Class III Devices
Justyna Kozik-Jaromin, HERAEUS MEDICAL GMBH

 

2:00 PANEL: PMCF BUDGET: FINANCIAL FORECASTING & SECURING EXECUTIVE LEADERSHIP BUY-IN

  • Strategies for PMCF budgetary planning
  • Maximizing buy-in for financial investment
  • Addressing clinical budget overspending

Paola Vivoda, ZIMMER BIOMET

Yanela González, NOBEL BIOCARE

Ruben Roijers, PHILIPS HEALTHCARE

 

2:45 CASE STUDY: CLINICAL EVIDENCE & PMCF STRATEGY
The pressures for companies to comply with new regulations and existing MEDDEV guidance has intensified, and post-market clinical follow-up is pivotal in driving two key factors for your product: safety and performance. A concentrated effort is necessary from all players – including sponsor, practitioner, and research team – to deliver effective and efficient results. Drawing from the experience of one small CRO that has found success managing three PMCF studies using two different approaches. This presentation on “packaging a PMCF” will provide insight for designing successful communication pathways, identifying key elements for data capture, and streamlining data collection techniques to ultimately produce a data set fit for FDA, the NB, and publication.

Barry Sands, President & Founder, RQMIS, INC.

 

3:30 COFFEE & NETWORKING BREAK

 

OPERATIONAL CHALLENGES IN DEPLOYING A ROBUST PMCF PLAN UNDER THE MDR

 

4:00 PART 1 – WORKSHOP: STRATEGICALLY MANAGING THE POST-MARKET REPORTING PROCESS
In order to deliver enhanced post-market clinical follow-up plans within the short period of time required by the new regulation, it is essential that companies optimize submission timelines for post-market clinical follow-up plans, clinical evaluation reports, and periodic safety update reports. Manufacturers must also be prepared to re-evaluate and adapt the plan in response to audit feedback and unforeseen circumstances in order to remain compliant over time. Through a collaborative hands-on exercise, participants will gain valuable insight into strategies implemented by others in the field to best plan for and execute large-scale post-market research reporting.

Josefine Sommer, Senior Associate, SIDLEY AUSTIN LLP

 

5:00 PART 2 – CASE STUDY: MANAGING THE IMPLEMENTATION OF MDR-COMPLIANT PMCF STUDIES

  • MDR-tailored PMCF trial development status
  • Objective resource forecasting:
    • Manpower & team structure
    • Device life-cycle timeline
    • Necessary budget
  • Challenges in simultaneous PMCF studies
  • Lessons learned in study implementation

Sabine Konopka, Director Clinical Affairs, PHENOX GMBH

 

5:45 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:45 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 October 29th. Please note that dinner expenses must be covered by each participant individually.

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