11th Annual EU Medical Device Clinical Research Conference

March 21-22, 2019 | Berlin, Germany

Crowne Plaza Berlin Potsdamer Platz

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DAY TWO | FRIDAY MARCH 22

7:30 REGISTRATION & COFFEE

8:00 CHAIRPERSON’S OPENING REMARKS
Rob Konterman, COO, CASTOR EDC

8:15 INTERVIEW: COMPETENT AUTHORITY INSIGHT INTO CRITICAL ASPECTS OF CLINICAL COMPLIANCE UNDER THE MDR
With a changing regulatory framework in the European Union, competent authorities’ assessment of applications is currently listed among the most prominent concerns for clinical and regulatory affairs professionals. The industry is also in need of clarification on the updated criteria and projected timelines for increased adverse event management during trials in addition to clinical study inspections, in order to optimize preparation of MDR-compliant strategies. Through this interview, participants are given the opportunity to submit questions to competent authority speakers ahead of the conference, ultimately providing insight into the most relevant grey areas for European clinical professionals.

INTERVIEWER:
Klaus Schichl, Director Clinical Affairs CRM/EP, BIOTRONIK

INTERVIEWEE:
Tom Melvin, Medical Officer, Medical Devices, HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA)

 

9:00 PANEL DISCUSSION: TRIAL DESIGN OPTIMIZATION THROUGH A CLEARLY DEFINED CLINICAL END-POINT
With the increase in authorities’ demands for meaningful clinical evidence generated through pre-market and also post-market trials, the very design of the study is of the utmost importance to determine data goals and establish an achievable plan. Professionals therefore aim to ensure the initial step in clinical research is considered with great attention, to warrant both the clinical hypothesis and study end-point are clearly defined. In order to set an explicit study target, it is crucial to understand how to precisely delineate a criteria for the end-point, ultimately impacting all operational aspects of trial development and design.

  • Criteria to define the end-point:
    • Pre-market trials
    • Post-market studies
  • Impact on operational aspects:
    • Patient numbers
    • Trial duration
    • Study budget
  • Use of statistics & measurement methods

MODERATOR:
Judith Koehnen, CHILTERN, A COVANCE COMPANY

PANELISTS:
Basira Salehi, BIOTRONIK

Dervilla Bermingham, FORMERLY BIOSENSORS EUROPE

Norbert Clemens, KANEKA PHARMA EUROPE & ACRP

Dorota Johansson, BACTIGUARD

Giacomo Mordenti, LIVANOVA

 

9:45 MAXIMIZING YOUR MEDTECH OPPORTUNITY IN THE NATIONAL HEALTH SERVICE (NHS)

  • Enhance your marketing strategy by generating clinical & cost effectiveness evidence in the NHS
  • Understand the UK’s clinical research infrastructure and free support services
  • Learn how to access: Fool-proof feasibility; streamlined site identification; quicker costing & contracts; rapid recruitment and proactive performance management
  • Company perspective: Hear case studies from a global leader in medical technology

Lucy Pollock, Senior Regional Clinical Leader for UK & Ireland, MEDTRONIC

Angela Birt, Industry Operations Manager
NATIONAL INSTITUTE FOR HEALTH RESEARCH CLINICAL RESEARCH NETWORK

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 RWE DATA SOURCES & COLLECTION METHODS TO FULFILL AUTHORITIES’ REQUIREMENTS & CORPORATE GOALS
Whether to meet health authorities’ demands for additional substantiation of product safety and effectiveness, or to achieve data goals that will benefit product development or reimbursement teams, an increasing focus is set on enhancing collection of evidence coming from the real-world setting. Clinical teams particularly target the use of registry or QoL studies to gather RWE, requiring for a good understanding of how to structure and manage operations to reach desired end-goals. Further, much discussion is ongoing in regard to the possibility of compliantly collecting and utilizing hospital and insurance records data, from within as well as outside of the European Union.

PART 1 – SET UP & UTILIZATION OF A REGISTRY STUDY

  • Key considerations in patient registry design
  • Data privacy & ethics committee concerns
  • Quality & volume of content to gather
  • Interpretation & utilization of data

Torsten Kayser, Senior Fellow, International Clinical Research, BOSTON SCIENTIFIC

11:30 PART 2 – QoL STUDY & USE OF QUESTIONNAIRES

  • Maximized QoL study structure considerations
  • Mobile & innovative data collection methods
  • Establishing a comprehensive questionnaire
  • Ensuring HCP engagement in data generation

Amir Kamali, Director, Global Clinical Scientific Affairs, SMITH & NEPHEW

 

12:00 INTERVIEW: ETHICS COMMITTEE PERSPECTIVES ON NEW EU REGULATIONS & ACCESS TO DATA
European ethics committees hold a key role in trial approval, and while the industry strives to meet requirements for authorization, clinical teams currently face challenges with unclear demands at times conflicting with MDR or GDPR provisions related to study design, as well as access to patient-related data and management thereof. Through this informal session led as an interview, an ethics committee representative will thoughtfully answer focused questions, in the effort of shedding light into timely areas of concern. The audience will be given the opportunity to directly submit pragmatic questions ahead of the conference, ensuring the most specific approach to current challenges.

INTERVIEWER: Yana Pozhidaeva, Senior Manager Clinical & Quality Assurance, ABBOTT

INTERVIEWEE: Joerg Hasford, President, Permanent Working Part
GERMAN RESEARCH ETHICS COMMITTEES

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 CONTINUOUS CLARIFICATION OF GDPR IMPACT ON CLINICAL OPERATIONS IN EUROPE

  • Ongoing grey areas in informed consent requirements
  • Addressing the “right to be forgotten” in clinical trials
  • Hospital Data Protection Officers’ role & rule enforcement
  • How to structure a clinical data strategy covering all points

Ibou Diop, Global Clinical Regulations Strategy Manager, Cardiovascular & Specialty Solutions Group
JOHNSON & JOHNSON

 

2:15 OVERCOMING CHALLENGES IN FULFILLING POSTMARKET CLINICAL FOLLOW-UP REQUIREMENTS

  • PMCF study design & setting objective data goals
  • MDR compliance for all marketed devices as of 2020
  • Moving from reactive address to proactive monitoring

Hendrik Lambert, Co-Founder, VP Clinical & Regulatory, GTX MEDICAL

 

3:00 COFFEE & NETWORKING BREAK

 

3:15 ANALYSIS OF NEW AREAS OF GUIDANCE IN THE UPCOMING ISO 14155:2019
ISO 14155 has been recognized as an efficient guideline for good clinical practice and clinical investigation conduct over a multitude of markets internationally since 2011, and widely utilized by medical device manufacturers with success. The standard has recently been revised, with the first draft publication released in 2018 and an announced adoption date end of 2019 for which the industry is eager to prepare efficiently. With the revision focused on aligning new regulations such as the MDR but also recent FDA rules, as well as enhancing harmonization of clinical requirements and data acceptability on a global level, it is of the highest interest to EU clinical affairs teams to gain insight into new areas of compliance.

  • Alignment with recent EU & US regulations
  • Enhancing risk management in investigations
  • Global harmonization of data acceptance
  • Applicability to post-market studies
  • Further new areas of impact on GCP

Yana Pozhidaeva, Senior Manager Clinical & Quality Assurance, ABBOTT

 

4:00 CLOSING REMARKS & CONFERENCE CONCLUSION