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Informa
Jun 17
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07:50 - 09:00

Registration

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Showing of Streams
11:00 - 11:40

Morning coffee and networking break

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Showing of Streams
13:00 - 14:20

Networking Lunch

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Showing of Streams
15:50 - 16:30

Afternoon tea and networking break

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Showing of Streams
17:50 - 17:55
Chair’s closing remarks and end of conference day one

Chair’s closing remarks and end of conference day one

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07:50 - 09:00 70 mins
Registration
09:00 - 09:10 10 mins
EU Medical Device Regulation
Chairperson’s opening remarks
  • Amanda Maxwell - Medtech Regulatory Affairs Editor, Medtech Insight, Pharma Intelligence, Informa, UK
09:00 - 09:10 10 mins
EU Medical Device Law
Chairperson’s opening remarks
  • Amanda Maxwell - Medtech Regulatory Affairs Editor, Medtech Insight, Pharma Intelligence, Informa, UK
09:10 - 09:45 35 mins
Info
EU Medical Device Regulation
Transitioning from the MDD to the MDR: a year to go
  • Speaker Invited: Graeme Tunbridge - Group Manager – Devices Regulatory Affairs, MHRA, UK
  • Outlining key MDR implementation activities taking place at an EU level
  • The current areas of focus for the MHRA in implementing the MDR
  • Addressing the challenges with notified body capacity
09:10 - 09:45 35 mins
Info
EU Medical Device Law
Transitioning from the MDD to the MDR: a year to go
  • Speaker Invited: Graeme Tunbridge - Group Manager – Devices Regulatory Affairs, MHRA, UK
  • Outlining key MDR implementation activities taking place at an EU level
  • The current areas of focus for the MHRA in implementing the MDR
  • Addressing the challenges with notified body capacity
09:45 - 10:20 35 mins
Info
EU Medical Device Regulation
Notified Body feedback: The EU Medical Device Regulation and preparing for implementation
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
  • Key learnings from the joint assessments
  • Assessing different Notified Body interpretations of MDR: How can we ensure a harmonised approach?
  • Understanding Notified body priorities for MDR implementation: when will industry be able to start submissions for certification according to the new rules? And with which product to start first?
  • Period between now and Date of Application: How long will Notified Bodies be accepting submissions according to the old MDD/AIMDD Rules?
09:45 - 10:20 35 mins
Info
EU Medical Device Law
Notified Body feedback: The EU Medical Device Regulation and preparing for implementation
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
  • Key learnings from the joint assessments
  • Assessing different Notified Body interpretations of MDR: How can we ensure a harmonised approach?
  • Understanding Notified body priorities for MDR implementation: when will industry be able to start submissions for certification according to the new rules? And with which product to start first?
  • Period between now and Date of Application: How long will Notified Bodies be accepting submissions according to the old MDD/AIMDD Rules?
10:20 - 10:55 35 mins
Info
EU Medical Device Regulation
Practically implementing the MDR: Large medical device manufacturer
  • Søren Holck - Director for Compliance & Systems, Coloplast AS
  • Undertaking a gap analysis to assess where additional resource and time and cost should be invested
  • Structure, timing and governance are essential
  • Strategies for continually monitoring the latest requirements and ensure progress despite uncertainty
  • Scoping resources internally to ensure compliance from a QMS and technical file perspective
  • Training and explaining: Communicating the key differences between the MDD and the MDR to staff in a meaningful way and explaining the new associated processes
10:20 - 10:55 35 mins
Info
EU Medical Device Law
Practically implementing the MDR: Large medical device manufacturer
  • Søren Holck - Director for Compliance & Systems, Coloplast AS
  • Undertaking a gap analysis to assess where additional resource and time and cost should be invested
  • Structure, timing and governance are essential
  • Strategies for continually monitoring the latest requirements and ensure progress despite uncertainty
  • Scoping resources internally to ensure compliance from a QMS and technical file perspective
  • Training and explaining: Communicating the key differences between the MDD and the MDR to staff in a meaningful way and explaining the new associated processes
10:55 - 11:00 5 mins
EU Medical Device Regulation
Question & Answer session
10:55 - 11:00 5 mins
EU Medical Device Law
Question & Answer session
11:00 - 11:40 40 mins
Morning coffee and networking break
11:40 - 11:45 5 mins
EU Medical Device Regulation
Opening remarks from the Chairperson
  • Amanda Maxwell - Medtech Regulatory Affairs Editor, Medtech Insight, Pharma Intelligence, Informa, UK
11:40 - 11:45 5 mins
EU Medical Device Law
Opening remarks from the Chairperson
  • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
11:45 - 12:15 30 mins
EU Medical Device Regulation
EU Medical Device Regulations, Notified Body overview and update from BSI
  • Jayanth Katta - Regulatory Lead, BSI UK Notified Body
12:15 - 13:00 45 mins
Info
EU Medical Device Regulation
Panel discussion: Beyond October 2019: Brexit and the MDR – what does it mean for implementation?
  • Thomas Wejs Møller - Section Manager - Medical Devices, Danish Medicines Agency, Denmark
  • Gert Bos - Executive Director & Partner, Qserve, Netherlands
  • Jayanth Katta - Regulatory Lead, BSI UK Notified Body
  • Graeme Tunbridge - Group Manager – Devices Regulatory Affairs, MHRA, UK
  • Understanding how Competent Authorities will approach Brexit
  • Understanding how Brexit will impact industry’s relationship with Competent Authorities 
  • Clarifying Notified Body procedures and the role of representatives based in the UK
  • Providing clarification on the position of Authorised Representatives based in the UK
  • Examining the extent to which Brexit is changing the way industry are preparing for implementation
12:15 - 12:45 30 mins
Info
EU Medical Device Law
Managing New Requirements for the Economic Operators Regime: Drafting and Negotiating Agreements
  • Erik Vollebregt - Partner, Axon Lawyers LLP, The Netherlands
  • Assessing legal obligations of manufacturers, authorised representative’s importers and distributors
  • Managing risk: documenting duties for your supply chain and managing ongoing obligations
  • Legal tools to manage and demonstrate compliance
  • Implementing and updating standard operating procedures
13:00 - 14:20 80 mins
Networking Lunch
14:20 - 15:20 60 mins
Info
EU Medical Device Regulation
NOTIFIED BODY PANEL DISCUSSION: An update on Notified Body designation: Scope, resource and timelines
  • Gert Bos - Executive Director & Partner, Qserve, Netherlands
  • Jayanth Katta - Regulatory Lead, BSI UK Notified Body
  • Bassil Akra - Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical), TÜV SÜD Product Service GmbH, Germany
  • Clarifying the timelines for Notified Body designation
  • Assessing Notified Body capacity and resource: how big is the window and will MDD certificates be extended?
  • Will your Notified Body have the scope? Understanding if and when your Notified Body will be able to re-certify your products
  • How will Notified Body delays impact certificates up for renewal and clarifying what will happen if certificates don’t get issued in time
  • What happens if your Notified Body goes out of business? When and how to switch your notified body
14:20 - 15:05 45 mins
Info
EU Medical Device Law
DUAL DIALOGUE Understanding and Managing Product Liability and Risks in the Supply Chain
  • Andrew Austin - Partner, Freshfields Bruckhaus Deringer LLP, UK and Member, EU Commission Expert Group on Liability and New Technologies
  • Amelie Chollet - Legal Regulatory Counsel, EMEA, Abbott Laboratories UK Ltd, UK
  • Overview of the European product liability regime and case law, and how these relate to wider regulation of medical devices
  • Guidance on identifying your potential liability and mitigating risks
  • Future developments: the Commission’s proposals to reform the Product Liability Directive and the draft Directive on consumer collective redress
15:05 - 15:50 45 mins
Info
EU Medical Device Law
DUAL DIALOGUE New Regulatory Requirements for Advertising and Promotion
  • Alison Dennis - Medical Device and Pharmaceuticals Lawyer, Head of Life Sciences Sector Group, Fieldfisher LLP, UK
  • Wojciech Olszewski - Senior Legal Counsel EMEA, Align Technology, B.V., The Netherlands
  • Update on regulations, promotion and advertising for medical devices across Europe
  • Provision of public information: guidance on listing adverse events, side effects and risk
  • Practical approach and scenarios: the do’s and don’ts of advertising
15:20 - 15:50 30 mins
Info
EU Medical Device Regulation
Countdown to the European Medical Device Regulation (MDR)
  • Oliver P. Christ, Dipl.-Ing. - Executive Vice President, PROSYSTEM GmbH, Germany
  • Access to Notified Body services is like a modern art of gambling (50:50 chance)
  • Implementing & Delegating acts make the MDR a moving target (with a deadline)
  • Overhaul of Labelling (UDI) & Technical Documentation cost can “kill” a Medical Device Company
  • The macro-economic consequences of MDR for European Consumer & Economic Operator
  • Lawsuits as last resort to restore fair competition for Medical Device(s) in Europe
15:50 - 16:30 40 mins
Afternoon tea and networking break
16:30 - 17:15 45 mins
Info
EU Medical Device Regulation
Software classification: Examining the new rule for medical device software
  • Koen Cobbaert - Senior Manager - Quality, Standards & Regulations, COCIR, Belgium
  • Clarifying and interpreting MDR Annex VIII: Section 6.3. Rule 11 and the requirements surrounding diagnostic decisions 
  • Understanding the different requirements for standalone and integrated software
  • Software apps and wearables: clarifying when a clinical investigation should be carried out to gain a CE mark
  • Industry case study
16:30 - 17:10 40 mins
Info
EU Medical Device Law
Own Brand Labelling and Virtual Manufacturing
  • Andreas Balsiger Betts - Senior Advisor, Sidley Austin LLP, Switzerland
  • Josefine Sommer - Senior Associate, Sidley Austin LLP, Belgium
  • Examining the changing contractual arrangements and liability under the MDR
  • Contractual measures to protect own brand labelling
17:10 - 17:20 10 mins
EU Medical Device Law
Questions & Discussion Session
17:15 - 17:50 35 mins
Info
EU Medical Device Regulation
ISO13485:2016 – Quality Management Systems (QMS) and the MDR: what’s new and how can industry prepare?
  • Vanessa Windscheid - Quality & Clinical Affairs Manager, Nipro Europe NV, Belgium
  • Assessing the role of the Quality Management Systems in ensuring compliance with the MDR
  • Organising Quality Management Systems internally and understanding how and why it is key to supporting MDR compliance
  • Understanding how quality and regulatory teams can collaborate to ensure safety and performance throughout the device lifecycle
17:50 - 17:55 5 mins
Chair’s closing remarks and end of conference day one