MEDICAL DEVICES PROGRAMME

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1 MEDICAL DEVICES PROGRAMME 3-4 October 2017 Medical Devices Symposium, updated 29August 2017, external Page 1

2 Working Party Margareth Jorvid LSM Group, Sweden (Chair) Michael Kipping MHRA, UK Janine Jamieson JCombinations AB, Sweden Tim Chesworth AstraZenenca, UK Gert Bos, Qserve Group BV, the Netherlands Nick Baker LRQA, UK Theresa Jeary LRQA, UK Medical Devices Symposium, updated 29August 2017, external Page 2

3 Tuesday 3 October 2016 Medical Devices Symposium Registration, exhibition and refreshments Introduction to Medical Devices Symposium Margareth Jorvid Methra Uppsala AB, LSM Group, Sweden Medical Devices Symposium, updated 29August 2017, external Page 3

4 SESSION 1: Optimising the implementation of the new MDR Leader: Margareth Jorvid Methra Uppsala AB, LSM Group, Sweden An overview of the future regulatory framework and the key changes in the new Medical Device Regulation (MDR). What will their impact be on industry and how can organisations best prepare to deliver the new requirements within the timelines? Chair: Margareth Jorvid Methra Uppsala AB, LSM Group, Sweden Introduction The new Medical Device Regulation Erik Hansson Deputy Head of Unit, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, Health Technology and Cosmetics, European Commission The new MDR What does the new Regulation include? Timelines for implementation Development of guidelines Implementation challenges, how to prepare Céline Bourguignon Director Global Regulatory Policy, Johnson and Johnson, Belgium Consequences for industry Preparation Transition period Panel discussion: How to work together moderated by Margareth Jorvid This session s speakers and speakers from Session 2 (Notified Body + Competent Authority) will take questions from the floor Lunch in Exhibition Hall Medical Devices Symposium, updated 29August 2017, external Page 4

5 SESSION 2: Implications of new regulatory oversight requirements Leader: Gert Bos, Qserve Group BV, the Netherlands The new MDR changes supervision requirements both for notified bodies (NBs) and competent authorities (CAs). There are changes to setting up as an NB, conformity assessment routes and methods of practice. For CAs there are more specific requirements on supervision of NBs, market surveillance, and formulating and approving delegated and implementing acts, as well as common specifications. Chair: Gert Bos Qserve Group BV, the Netherlands Introduction In recent years, additional instructions and guidance to notified bodies have been issued, resulting in stricter conformity assessment routes. In addition, the 2016 publication of the MEDDEV 2.7/1 rev.4 guidance on clinical evaluation has further enhanced the expectations to keep products on the market. Key players from CAs and NBs will explore their new level of expectations, and will provide guidance and explanations to the audience Impact on Notified Body Bassil Akra Vice President Global Focus Teams Cardiovascular, Orthopedic and Clinical, TUEV SUED Product Service, Germany Important steps towards a successful notification according to the new Regulation Impact of the guidance document on the medical device manufacturer portfolio New duties of the notified bodies during the approval process and post-market surveillance activities Impact on Competent Authority John Wilkinson Director of Devices Division, MHRA, UK New responsibilities for competent authorities Expanded or more specific extensions to current responsibilities Role of CAs in more complex set of necessary collaborations across the system and the product lifecycle Panel discussion moderated by Gert Bos This session s speakers and speakers of Session 1 (Commission + Industry) will take questions from the floor Break End of Session 2 Medical Devices Symposium, updated 29August 2017, external Page 5

6 SESSION 3: Embracing the digital healthcare revolution Leader: Tim Chesworth, AstraZeneca, UK The effective use of apps, connected devices and other digital support services has the potential to have a profound and positive impact on patient outcomes. Regulators recognise this and are trying to adapt in a rapidly changing technological environment. Where do regulators and industry need to collaborate further to ensure patients can realise digital health benefits in a timely but safe and controlled manner? Chair: Tim Chesworth, AstraZeneca, UK Introduction The future and challenges of software regulation Valerie Field Head of Devices Software/apps, Devices, MHRA, UK Pace of new technology Challenges for Regulation Future guidance Industry challenges with medical device software Kirsten Paulson Pfizer, US Development costs and timelines Change control across countries and over time MDR implementation Releasing software every week in a regulated environment David Hubanks Propeller Health, US Agile development overview Mapping agile to ISO & 21 CFR 820 Practical results (and the danger of too many doughnuts) Improvement paths & next steps Panel discussion moderated by Tim Chesworth This session s speakers will take questions from the floor End of Session 3 Delegates move to Human Medicines Symposium TOPRA Board update and student poster winners announced Networking drinks in exhibition hall followed by freedom to explore London Medical Devices Symposium, updated 29August 2017, external Page 6

7 Margareth Jorvid LSM Group, Sweden Wednesday 4 October 2017 Session 4: [Combined Human Medicines and Medical Devices] Medicinal products incorporating device components significant change ahead Leader: Janine Jamieson JCombinations AB, Sweden The new Medical Device Regulation will amend medicines regulation to involve notified bodies in review of medicinal products incorporating integral medical devices. At the same time, the EMA is proposing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, highlighting the increasing importance of such combinations in healthcare treatments. Chair: Janine Jamieson JCombinations AB, Sweden Introduction EMA perspective on increasing focus on review of device components of medicinal products Armin Ritzhaupt Regulatory Affairs Officer, EMA Update from CHMP QWP/BWP draft Concept Paper on developing guidance on Quality of drug device combination products The new Medical Device Regulation amending medicines legislation to require review by notified bodies for some integral device components role and responsibilities of EMA Experience from reviews of medicinal products incorporating device components and collaborations with notified bodies Notified body perspective and advice on when and how to engage notified bodies Theresa Jeary LRQA, UK Current reviews of drug delivery devices for conformity with safety and performance requirements How will review of integral devices differ from current procedures? Advice for pharma and device manufacturers on timelines and data expectations for notified body assessment Global perspective update from the FDA Office of Combination Products, including working with other regions towards harmonisation of requirements FDA speaker invited Current focus on combination and complex products at the FDA Combination products Policy Council and the intercenter consult process pilot building relationships between drug and device reviewers FDA Final Rules and Guidances on cgmp and Post-market Combination Product Safety Reporting. Medical Devices Symposium, updated 29August 2017, external Page 7

8 10.05 Panel discussion moderated by Janine Jamieson The speakers will take questions from the floor with invited panelist Elizabeth Baker, Group Manager Licensing Division, MHRA, UK Break Medical Devices Symposium, updated 29August 2017, external Page 8

9 SESSION 5: [Combined Human Medicines and Medical Devices] Personalised medicine: In vitro diagnostics and companion diagnostics Leader: Nick Baker LRQA, UK A look at the new In Vitro Diagnostics (IVD) Regulation and its potential impact on industry, eg, under the new classification and conformity assessments most IVD assays will be reviewed by a notified body. Companion diagnostics also have their own particular conformity assessment requirements requiring notified bodies to consult either with the EMA or competent authorities. How will this work in practice for pharmaceutical and diagnostics manufacturers? Chair: Nick Baker Technical Manager, LRQA, UK Introduction An overview of the new In Vitro Diagnostics Regulation (IVDR) Nick Baker LRQA, UK New classification system Consultation process Workload challenges Competent authority perspective Daryl Colombage - Senior Medical Device Specialist, MHRA, UK IVDR and companion diagnostics Performance studies and evaluation Current situation Challenges for industry Peter Martin Roche Diagnostics Panel discussion moderated by Nick Baker, with this session s speakers and invited panelist Armin Ritzhaupt, Regulatory Affairs Officer, EMA, taking questions from the floor Light lunch Continue in Human Medicines Symposium: SESSION 6: UK Exit From the EU Leader: David Jefferys, Eisai Medical Devices Symposium, updated 29August 2017, external Page 9

10 The impact of the UK s decision to leave the EU will be significant for the pharmaceutical and medical devices industry as well as the EMA and the MHRA. The process to withdraw will be complex and will take at least two years to complete. Although the final outcomes are as yet unknown, this session will consider preparations being made by the MHRA and EMA. Potential impacts on the UK and European industries will also be discussed in the light of emerging scenarios. Chair: David Jefferys Senior Vice President, Eisai, UK Introduction David Jefferys Senior Vice President, Eisai, UK What is known to date and what is still to be determined MHRA preparations made to date and the process for future discussions Jonathan Mogford Director of Policy and Andy Gregory Head of EU, International Policy and Strategy, MHRA An overview of preparations the MHRA has made to date, given the remaining uncertainties. To provide the audience with information on what process and communication from the MHRA can be anticipated in the coming months How the EMA is preparing and what has been decided so far Noel Wathion Deputy Executive Director, EMA Pharmaceutical industry views and the possible future impact for the pharmaceutical industry Virginia Acha Executive Director Research, Medical & Innovation, The Association of the British Pharmaceutical Industry (ABPI), UK Medical device industry views and the possible future impact for the devices industry Neil R Armstrong CEO, MeddiQuest, UK Panel discussion moderated by chair This session s speakers will take questions from the floor Closing remarks by MHRA Close of Symposium by TOPRA President End of Symposium Medical Devices Symposium, updated 29August 2017, external Page 10

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