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Jun 12
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09:00 - 09:10

Chairperson's opening remarks

Showing of Streams
10:20 - 11:00

Morning coffee and networking break

Showing of Streams
12:10 - 13:30

Networking lunch

Showing of Streams
14:40 - 15:20

Afternoon tea and networking break

Showing of Streams
16:30 - 16:35
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 UDI 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 - 11:00 40 mins
Morning coffee and networking break
11:00 - 11:35 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
11:00 - 11:35 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?
11:00 - 11:35 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
11:00 - 12:10 70 mins
Post Market Surveillance and Vigilance
EXTENDED 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?
11:35 - 12:10 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
11:35 - 12:10 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
11:35 - 12:10 35 mins
Clinical Evaluations and Investigations for Medical Devices
Presentation to be delivered by Indegene
12:10 - 13:30 80 mins
Networking lunch
13:30 - 14:40 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
13:30 - 14:05 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
13:30 - 14:05 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
14:05 - 14:40 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
14:05 - 14:40 35 mins
Clinical Evaluations and Investigations for Medical Devices
Clinical evaluations: Moving from MDD to MDR
  • Vincent Legay - Senior Project Manager, NAMSA, France
more
14:05 - 14:40 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
14:40 - 15:20 40 mins
Afternoon tea and networking break
15:20 - 15:55 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
15:20 - 15:55 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
15:20 - 15:55 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
15:20 - 15:55 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
15:55 - 16:30 35 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
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.

15:55 - 16:30 35 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
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.

15:55 - 16:30 35 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
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.

15:55 - 16:30 35 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
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.

16:30 - 16:35 5 mins
End of conference day two