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Informa
Jun 11
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07:50 - 08:50

Registration

08:50 - 09:00

Chairperson's opening remarks

  • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
more
Showing of Streams
11:00 - 11:40

Morning coffee and networking break

Showing of Streams
12:50 - 14:00

Networking Lunch

Showing of Streams
15:10 - 15:50

Afternoon tea and networking break

Showing of Streams
17:00 - 17:05
Chair's closing remarks and end of conference day

Chair's closing remarks and end of conference day

07:50 - 08:50 60 mins
Registration
08:50 - 09:00 10 mins
Chairperson's opening remarks
  • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
more
09:00 - 09:20 20 mins
Opening Plenary Session
Scientific and technical challenges of the novel EU medical devices legislative framework
  • Arnd Hoeveler - Head of Unit of JRC (Joint Research Centre), European Commission, Italy
more
  • Reviewing the scientific and technical challenges of the novel EU medical devices legislative framework
09:20 - 09:40 20 mins
Opening Plenary Session
SME perspective: Where are we with EU MDR implementation?
  • Susana de Azevedo Wäsch - Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland
more
  • Understanding what has already been done and what are the next steps
  • Discussing the impact of the EU MDR and how business models need to change
  • Exploring lessons learnt so far
  • Outlining key challenges already faced and future concerns
09:40 - 10:00 20 mins
Opening Plenary Session
Competent Authority perspective: Practical advice and expectations for industry in preparing for EU MDR implementation
  • Graeme Tunbridge - Group Manager – Devices Regulatory Affairs, MHRA, UK
more
  • Examining latest progress on the implementation roadmap initiative from the EU Commission and national Competent Authorities
  • Discussing what has already been done for preparation and implementation
  • Exploring a harmonised approach amongst Competent Authorities for EU MDR implementation
  • Understanding a Competent Authority viewpoint on key challenges faced by industry
  • Exploring recent and upcoming challenges
10:00 - 10:20 20 mins
Opening Plenary Session
Perspective on Notified Bodies: Preparing for EU MDR implementation and expectations for industry
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
more
  • Discussing status of preparation and implementation
  • Understanding the impact of implementing and delegated acts on Notified Bodies
  • Clarifying expectations for how industry should be preparing
  • Practical advice for industry operating under a potential shortage of Notified Bodies
  • Outlining key challenges already faced and future concerns
10:20 - 11:00 40 mins
Opening Plenary Session
IMPLEMENTATION PANEL DISCUSSION: Sharing experiences with interpreting and implementing the EU MDR in practice
  • Gert Bos - Executive Director & Partner, Qserve Group, The Netherlands
  • Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
  • Hans-Heiner Junker - Senior International Affairs Manager, TÜV SÜD Product Service, Germany
  • Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
  • Alexander Natz - Director General, EUCOPE, Belgium
  • Rainer Voelksen - VP Regulatory & Quality Affairs, Occlutech, Germany
  • Lincoln Tsang - Partner, Arnold & Porter, UK
more

During this interactive session, Notified Body and industry experts will comment on their key experiences and challenges faced to date with interpreting and implementing the new EU MDR. Attendees will then have the opportunity to ask questions and take part in group discussion addressing some of the following topics:

  • How are different companies progressing with implementing the new MDR?
  • What are they key advantages and positive experiences seen so far?
  • What challenges lie ahead and what still needs to be addressed?
  • Comparing requirements and implementation requirements of the EU MDR and IVDR
  • Brexit – what is the latest status and impact on manufacturers, Notified Bodies and Competent Authorities?
11:00 - 11:40 40 mins
Morning coffee and networking break
11:40 - 12:15 35 mins
EU Medical Device Regulation
Notified Body perspective: Preparing for re-designation and latest status of the application process
  • Julien Sénac - Certification Project Manager, LNE/G-MED, USA
more
  • Discussing timelines: What is the current status of the re-designation process and are there any delays?
  • Reviewing how the application process is going, which NBs have applied and which have withdrawn
  • Exploring strategies and coordinated approaches taken to apply for re-designation
  • Understanding how the EU Commission and Competent Authorities are managing the review of applications
  • Sharing first practical experiences and challenges with recertification under the new EU MDR
  • Examining the impact re-designation will have on the issuing of MDD and MDR certificates
11:40 - 12:15 35 mins
EU Medical Device Law
Practical implications of the new regulations and case law on commercial relationships
  • Jackie Mulryne - Counsel, Arnold & Porter, UK
  • Ewan Townsend - Counsel, Arnold & Porter, UK
more
  • Impact on existing and future commercial relationships and deal structure
  • The need to consider regulatory compliance
  • Management and implementation of increased oversight and obligations on economic operators
  • Contractual enforcement with commercial partners, and implications on liability and risk sharing
12:15 - 12:50 35 mins
EU Medical Device Regulation
PANEL DISCUSSION: Sharing latest experiences and concerns on the Notified Body re-designation process
  • Guy Buijzen - RA Manager/Senior Project Manager, DEKRA, The Netherlands
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
  • Julien Sénac - Certification Project Manager, LNE/G-MED, USA
more
  • What are the first practical experiences for NBs and manufacturers following the re-designation process?
  • Are any manufacturers at an advantage/disadvantage following the re-designation process?
  • What are the main concerns?
  • How will the re-designation process impact SME companies and how can they be prepared?
12:15 - 12:50 35 mins
EU Medical Device Law
Understanding new liability rules under the MDR
  • Sean Fahey - Partner, Pepper Hamilton LLP, USA
more
  • Outlining specific provisions for manufacturers and authorised representatives
  • Reviewing the provisions related to product liability and product liability case law
  • Exploring where economic operators will have liability for defective products
  • Understanding the role of Competent Authorities in facilitating liability claims for defected devices
  • Clarifying sanctions for non-compliance and examples of enforcement
12:50 - 14:00 70 mins
Networking Lunch
14:00 - 14:35 35 mins
EU Medical Device Regulation
Outlining significant changes in the responsibilities and obligations of economic operators under the EU MDR
  • Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
more
  • Discussing the requirements for economic operators in the new EU MDR
  • Reviewing contractual considerations to be aware of
  • Examining any new risks for manufacturers that come with new obligations of economic operators
  • Clarifying who and at what stage has responsibility for UDI
14:00 - 14:35 35 mins
EU Medical Device Law
Person Responsible for Regulatory Compliance
  • Bjorn Delbeecke - Regulatory Affairs Specialist EMEA, Agfa HealthCare, Belgium
more
  • Determining where the Person Responsible for Regulatory Compliance can reside 
  • Understanding the personal liability of the Person Responsible for Regulatory Compliance
  • Discussing whether the role of Person Responsible for Regulatory Compliance can be outsourced
  • Addressing how a Person Responsible for Regulatory Compliance could be insured 
14:35 - 15:10 35 mins
EU Medical Device Regulation
Latest updates on the MDSAP program including Canada’s 1 January 2019 deadline and impacts on industry
  • Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
more
  • Understanding what MDSAP involves and who the key stakeholders are
  • Reviewing how MDSAP can impact auditing time and market access
  • Latest updates on Canada’s 1 January 2019 deadline for companies to transition from CMDCAS to MDSAP certificates
  • Practical advice for industry preparing to get certificates in place
14:35 - 15:10 35 mins
EU Medical Device Law
Presentation to be delivered by White & Case LLP
  • Axel Schulz - Partner, White & Case LLP, Belgium
more
15:10 - 15:50 40 mins
Afternoon tea and networking break
15:50 - 16:25 35 mins
EU Medical Device Regulation
Understanding the role of CEN and CENELEC (and their European standards) in the context of the new EU MDR and their priorities for ensuring a smooth transition
  • Catherine Vigneron - Customer Service Specialist, Standardization and Digital Solutions, CEN-CENELEC Management Centre
more
  • Discussing the link between standards and the existing Directives
  • Reviewing how standards will need to respond and revise under the new Regulations
  • Presenting a timeframe for the delivery of harmonised standards under MDR
  • Ensuring a smooth transition to the new Regulations for all key stakeholders
16:25 - 17:00 35 mins
EU Medical Device Regulation
End of conference day one
17:00 - 17:05 5 mins
Chair's closing remarks and end of conference day