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Jun 12
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09:00 - 09:10

Chairperson's opening remarks

Showing of Streams
10:45 - 11:15

Morning coffee and networking break

Showing of Streams
12:25 - 13:45

Networking lunch

Showing of Streams
14:55 - 15:25

Afternoon tea and networking break

Showing of Streams
17:00 - 17:05
End of conference day two

End of conference day two

09:00 - 09:10 10 mins
Chairperson's opening remarks
09:10 - 09:45 35 mins
EU Medical Device Regulation
EUDAMED: Latest timelines and updates
  • Céline Bourguignon - Chair of the MedTech Eudamed Taskforce, MedTech Europe, Belgium
more
  • Outlining latest timelines for finalisation of EUDAMED
  • Clarifying which information will be transparent to the public, manufacturers, Competent Authorities, distributors and importers
  • Discussing the changes needed to be made internally to be prepared for EUDAMED
  • Examining where and to whom to submit PSURs until EUDAMED is up and running
  • Understanding how Competent Authorities will use EUDAMED including for PMS responsibilities
  • Reviewing how Notified Bodies plan to utilise EUDAMED
09:10 - 09:45 35 mins
Clinical Evaluations and Investigations for Medical Devices
Case study: Exploring the key impacts of the EU MDR and EUDAMED developments on clinical evaluations and investigations
  • Carine Cochereau - QRA and Clinical Director EMEA, Cardinal Health, Belgium
more
  • Outlining the key ways in which the new MDR will impact clinical evaluations and investigations
  • Reviewing key developments to EUDAMED and how these will impact clinical modules
  • Exploring what industry should be doing to prepare
09:10 - 09:45 35 mins
Post Market Surveillance and Vigilance
Exploring the changes in the new MDR relating to post market surveillance (PMS) and vigilance
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
more
  • Examining the key areas of the MDR that will impact PMS and vigilance
  • Determining how changes to PMS and vigilance requirements will impact industry
  • Exploring the current status of the UDI rule in Europe and how this impacts PMS and vigilance
  • Overcoming key PMS and vigilance challenges
09:45 - 10:20 35 mins
EU Medical Device Regulation
Case study: Practically getting into compliance with Unique Device Identification (UDI): Latest status, requirements and practically preparing in Europe
  • Bianca M. Gravenhorst Greve - Senior RA Manager, Coloplast A/S, Denmark.
  • Inge Ørnhøj - Senior Master Data Manager, Coloplast A/S, Denmark
more
  • Outlining the regulatory and master data point of view for UDI compliance
  • Exploring the steps taken for compliance
  • Overcoming key challenges and pitfalls
09:45 - 10:20 35 mins
Clinical Evaluations and Investigations for Medical Devices
Competent Authority perspective: Expectations from industry on new requirements for clinical evaluations and investigations under the MDR
  • Tom Melvin, Health Products Regulatory Authority, Ireland
more
  • Sharing experiences on the assessment of technical files including CERs
  • Discussing expectations for what is sufficient clinical evidence?
  • Exploring clinical evidence expectations for legacy products
09:45 - 10:20 35 mins
Post Market Surveillance and Vigilance
Case study: Developing an ISO guidance document for PMS
  • Arjan van Drongelen - Scientific Officer, National Institute for Public Health and the Environment (RIVM), The Netherlands
more
  • Practically developing an ISO guidance document for PMS
  • Case examples
10:20 - 10:45 25 mins
EU Medical Device Regulation
The Big Picture: UDI and the Product Visibility and Control Imperative
  • Jay Crowley - VP of UDI Services and Solutions, USDM, USA
more
  • There are many new UDI and UDI-like requirements being introduced globally.
  • All of these are intended to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities.
  • These activities cover the total lifecycle of a device – including design, manufacturing, distribution, and postmarket surveillance – and will ultimately include long-term safety, effectiveness, and value.
  • All of this requires manufacturers to have a level of control and visibility over their products and processes that probably do not exist today, and which may require new systems to support these activities.
10:20 - 10:45 25 mins
EU Medical Device Law
Interactive Q&A Session
more

A chance for questions from the morning session

10:20 - 10:45 25 mins
Clinical Evaluations and Investigations for Medical Devices
Interactive Q&A Session
more

A chance for questions from the morning session

10:20 - 10:45 25 mins
Post Market Surveillance and Vigilance
Designing the Quality Management System to ensure compliance with MDR Post-Market Surveillance requirements
  • Liam Turley - CEO, Trinzo, Ireland
more
  • System for Updating Technical Documentation on PMS
  • Reporting and Investigation of serious incidents
  • Input of Post-Market Clinical follow up
  • Input of Surveillance assessments
  • ISO 13485:2016 requirements (Clause 8: Measurement, Analysis and Improvement)
10:45 - 11:15 30 mins
Morning coffee and networking break
11:15 - 11:50 35 mins
EU Medical Device Regulation
Clarifying the relationship between ISO 13485:2016 – Quality Management Systems (QMS) and the EU MDR
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
more
  • Exploring the relationship and alignment between the EU MDR and ISO 13485:2016
  • Outlining specific MDR quality requirements to be aware of
  • Practical advice for industry to prepare for upcoming requirements
11:15 - 11:50 35 mins
EU Medical Device Law
PANEL DISCUSSION: Sharing experiences with preparing for requirements of the GDPR
  • Wolfgang Werner - VP Regulatory and Quality, Biovotion AG, Switzerland
  • Olivier Mignolet - Partner, Simmons & Simmons, Belgium
more
  • What has been done/what are we doing to prepare for the GDPR May 2018 deadline?
  • How is the GDPR being implemented effectively alongside the MDR and/or IVDR?
  • Success stories
  • What are the key challenges experienced so far and how have they been overcome?
11:15 - 11:50 35 mins
Clinical Evaluations and Investigations for Medical Devices
Competent Authority perspective: Expectations for clinical investigations and GCP under the MDR
  • Tim De Schutter - Inspector Medical Devices, FAMHP, Belgium
more
  • Outlining implications for clinical investigations and GCP in the MDR
  • Discussing how this impacts industry
  • Overcoming key challenges and pitfalls
11:15 - 11:50 35 mins
Post Market Surveillance and Vigilance
PANEL DISCUSSION: How are different companies practically implementing new PMS and vigilance requirements under the new MDR?
  • Fayez Abou Hamad - MD Vigilance Expert – Pharmacist, Terumo Europe N.V., Belgium
  • Nathalie Gerard - Medical Device Vigilance Specialist, Terumo Europe N.V., Belgium
  • Andrea Sparti - Regulatory Affairs Manager, Cendres+Métaux SA, Switzerland
more

This interactive session will provide examples of how companies of different sizes and with different product types are practically implementing new requirements for PMS and vigilance.

  • How have PMS and vigilance processes at different companies been impacted by new MDR requirements?
  • How are different companies implementing post-market data collection?
  • Sharing success stories
  • What are the main PMS and vigilance challenges experienced?
11:50 - 12:25 35 mins
EU Medical Device Regulation
Outlining significant changes for manufacturers falling under the self-certification process (Class I and custom made devices)
  • Katrien Martens - Inspector, FAMHP, Belgium
more
  • General obligations for manufacturers
  • What will be the impact of the new definitions and new classification rules
  • When to involve a NB
  • Timelines for manufacturers of Class I and custom made devices
11:50 - 12:25 35 mins
EU Medical Device Law
The global courtroom: Strategies for managing cross-border products liability litigation
  • Lori G. Cohen - Shareholder; Chair, Pharmaceutical, Medical Device & Health Care Litigation Group; Chair, Trial Practice Group, Greenberg Traurig LLP, USA
  • Maria H. Bragaglia - Partner, Demarest Advogados, Brazil
  • Ashley L. Paterson - Associate, Bennett Jones LLP, Canada
  • Aimee H. Wagstaff - Partner, Andrus Wagstaff, USA
more
11:50 - 12:25 35 mins
Clinical Evaluations and Investigations for Medical Devices
Clinical evaluation of software as a medical device: Challenges and Indegene’s perspective
  • Priya Kumar - Senior Manager, Medical Services, Indegene Inc., India
  • Sudy Vengarai - Sr. Account Director, Indegene Inc., USA
more
  • Software as a medical device and its rapidly evolving role in healthcare
  • The role of existing guidelines for clinical evaluation of SaMD
  • Approach for clinical evaluation for a SaMD
  • Challenges in generating and assessing evidence for SaMD
  • Future perspectives on evolving regulatory guidelines of SaMD
11:50 - 12:25 35 mins
Post Market Surveillance and Vigilance
Finding the right information for Medical Device Clinical Evaluation and PMS
  • Ivan Krstic - Embase Senior Product Development Manager, Elsevier Information Systems, Germany
more

Information found in the biomedical literature is a significant source for every stage of the medical device life cycle, from concept and design through clinical trials to release and reimbursement, as well as post-market surveillance (PMS).

In June 2016, the updated Medical Device Clinical Evaluation Report (CER) guidelines came into effect (Revision 4 of MEDDEV 2.7/1), detailing where and how to search for literature and how to record the process of collecting, appraising and analyzing the items found.

In this session, Elsevier's senior product manager Dr. Ivan Krstic demonstrated how Embase is especially suited to help Medical Device manufacturers to prepare CER, including:

- How to design effective literature searches for Clinical Evaluation reports using the PICO search form in Embase;
- How to build a more comprehensive search using Emtree terms and synonyms;
- How trade name and manufacturer name indexing supports analyses of devices already on the market;
- How to find mentions of adverse device reactions in the literature for effective PMS reporting

12:25 - 13:45 80 mins
Networking lunch
13:45 - 14:55 70 mins
EU Medical Device Regulation
Exploring the regulatory qualification, classification and future of medical device software
  • Koen Cobbaert - Chair COCIR Medical Software Task Force, Quality & Regulatory Affairs Manager and Manager Risk Management Process, AGFA Healthcare, Belgium
  • Mette Kraag Luxhøj - Regulatory Affairs Manager, Co-Chair Medtech Europe Medical Software Task Force, Radiometer, Denmark
more

Qualification: 

  • Understanding the borderline between medical devices and lifestyle and wellness apps
  • Exploring the borderline between IVD and Medical Device Software
  • Discussing the qualification of Drug-Device-Software-IT
  • Understanding when software drives or influences the use of a medical device or is an accessory of a medical device

Classification 

  • Clarifying revised classification rules for software and how this differs from before
  • Understanding which types of software are classified into which class
  • Outlining the risks of software being significantly up-classified in the new MDR and implications for industry

The future of health IT 

  • Artificial intelligence, cloud computing, mHealth and eHealth
  • Implications for product development within the European Regulatory system
  • Exploring the different regulatory approaches across the EU and in the US
  • Understanding where manufacturers need to be cautious in design product development program to fulfil the regulatory requirements both for US and EU.
  • Identifying future regulatory developments that specifically impact medical device software
13:45 - 14:20 35 mins
Clinical Evaluations and Investigations for Medical Devices
Notified Body perspective: Practical advice for industry on meeting new requirements for clinical evaluations and investigations under the MDR
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
more
  • Explaining the process of pre-submission advice before a company starts a clinical study
  • Sharing experiences on the assessment of technical files including CERs
  • Reviewing clinical evidence expectations for legacy products
13:45 - 14:20 35 mins
Post Market Surveillance and Vigilance
Exploring the impact the obligations of economic operators will have on manufacturers’ implementation of the PMS process
  • Andrea Sparti - Regulatory Affairs Manager, Cendres+Métaux SA, Switzerland
more
  • Reviewing key ways in which these economic operators obligations will impact PMS implementation
  • Discussing how this is set up at Cendres+Métaux
  • Assessing the challenges this will create for manufacturers and how these can be overcome
14:20 - 14:55 35 mins
EU Medical Device Law
Reviewing the current status of advertising and claims for medical devices
  • Bill Kurani, MSRA, MSEE - Head of RA/QA, Genomics, Agilent Technologies, USA
more
  • Discussing what is included in Article 5a
  • Considerations for labelling
  • Understanding requirements related to intended purpose
  • Exploring the sanctions for non-compliance
  • Recent case law
14:20 - 14:55 35 mins
Clinical Evaluations and Investigations for Medical Devices
Clinical evaluations: Moving from MDD to MDR
  • Vincent Legay - Senior Project Manager, NAMSA, France
more
14:20 - 14:55 35 mins
Post Market Surveillance and Vigilance
Case study: Compiling post market surveillance (PMS) plans and meeting requirements of the new MDR
  • Andrea Castañeda - Associate Manager - International Quality Compliance, Edwards Lifesciences, Spain
more
  • Exploring requirements in the new MDR for constructing PMS plans
  • Clarifying what should be included in a PMS plan and the appropriate format
  • Understanding whether PMS plans should be compiled for each product or product families
  • Overcoming key challenges and pitfalls with implementing PMS plans
14:55 - 15:25 30 mins
Afternoon tea and networking break
15:25 - 16:00 35 mins
EU Medical Device Regulation
Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
more
  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
15:25 - 16:00 35 mins
EU Medical Device Law
Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
more
  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
15:25 - 16:00 35 mins
Clinical Evaluations and Investigations for Medical Devices
Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
more
  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
15:25 - 16:00 35 mins
Post Market Surveillance and Vigilance
Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
more
  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
16:00 - 17:00 60 mins
EU Medical Device Regulation
OPEN FLOOR Q&A INTERACTIVE SESSION
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
  • Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
more

This closing interactive session will allow time for open discussion and questions accumulated over the course of the meeting so far, posed to a panel of experts.

16:00 - 17:00 60 mins
EU Medical Device Law
OPEN FLOOR Q&A INTERACTIVE SESSION
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
  • Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
more

This closing interactive session will allow time for open discussion and questions accumulated over the course of the meeting so far, posed to a panel of experts.

16:00 - 17:00 60 mins
Clinical Evaluations and Investigations for Medical Devices
OPEN FLOOR Q&A INTERACTIVE SESSION
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
  • Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
more

This closing interactive session will allow time for open discussion and questions accumulated over the course of the meeting so far, posed to a panel of experts.

16:00 - 17:00 60 mins
Post Market Surveillance and Vigilance
OPEN FLOOR Q&A INTERACTIVE SESSION
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
  • Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
more

This closing interactive session will allow time for open discussion and questions accumulated over the course of the meeting so far, posed to a panel of experts.

17:00 - 17:05 5 mins
End of conference day two