Date: 17 & 18 October 2023

Timing: 08.30 to 19.00 on Day 1/ 08.30 – 16.30 on Day 2

Venue: The Hilton Paddington, London

What’s this BSI/AAMI International Standards & Regulation Conference about?

This two-day in-person and online event will give delegates important updates on a wide range of issues affecting the global medical devices/healthcare market.

With a focus on patient safety, we’re covering most of the sector’s current ‘hot topics’ from AI regulations in Europe and the UK, to an update on the EU MDR transition proposal. Our top speakers include global regulators, clinical professionals, medical device company experts and consultants, plus representatives from notified/approved bodies and national standards bodies.

At the end of Day 1, delegates can join a networking reception.

Who should attend the BSI/AAMI International Standards & Regulation Conference?

Everyone operating in the global healthcare/medical devices space and in adjacent disciplines, e.g. Artificial Intelligence.

What will participants gain?

• the latest information on key topics impacting the medical devices sector
• expert knowledge and insights including from regulators and notified bodies
• in-person networking opportunities to establish professional contacts and build relationships
• a post-event copy of all presentations and a recording for future reference.

Agenda

Tuesday 17th October 2023

08.00 – 08.30 Registration/Coffee/Tea                            

08.30 – 08.45 Welcome & Opening remarks

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

08.45 – 09.30 Global regulatory outlook – current issues & future challenges

Graeme Tunbridge, SVP Global Regulatory and Quality, Regulatory Services

09.30 – 10.45  Artificial Intelligence/Machine Learning, AI Regulation, AI Standards – What Next?        

Aris Tzavaras, RS Head of AI Notified Body, BSI

Graeme Tunbridge, SVP Global Regulatory and Quality, Regulatory Services, BSI

Alastair Denniston, Consultant Ophthalmologist, Professor, University of Birmingham

Carlos Muñoz Ferrandis, AI Governance & Regulation Counsel

Daniela Seneca, RS Regulatory Lead AI Notified Body, BSI

10.45 – 11.15  Networking Tea/Coffee Break

11.15 – 12.00  Update on the EU MDR Transition Proposal NB Resource

Dr Purvi Patel, RS Regulatory Lead, BSI

12.00 – 13.00   UK Medical Device Regulations update 

Dr Purvi Patel, RS Regulatory Lead, BSI

Lynn Heaver, Director, Regulatory Affairs, UK/Ireland, Johnson & Johnson 

Paul Campbell, Head of Software and AI, Innovative Devices Division, MHRA 

13.00 – 14.15  Networking Lunch

14.15 – 15.30  Clinical data & Clinical Investigations    

Richard Holborow, RS Head of Clinical Compliance, BSI

Rachel Mead, RS Clinical Regulatory Lead, BSI

Dr Amie Smirthwaite, Senior. VP, Global Intelligence & Innovation, RQM+

15.30 – 16.00 Networking Tea/Coffee break

16.00 – 17.00  FDA briefing, Implementing Rule QSR’s/ISO 13485 MDSAP International Affairs updates

Davina R Marano, Senior Regulatory Counsel, FDA International affairs Office 

Neil A Mafnas, Senior Program Management Officer, FDA International affairs

17.00 – 17.10 Chair’s Concluding Remarks

17:15 – 18.15 Networking Reception

Wednesday 18^th October 2023    

08.00 – 08.30  Registration Coffee/Tea                              

08.30 – 08.45  Chairman’s welcome & Opening remarks            

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

08.45 – 09.30 Keynote address, questions & answers

Wendy Rayner, Head of NHS Circular Economy Program, Scottish Government

09.30 – 11.00 Sustainability, single use, reprocessing, re-use, remanufacture, conformity assessment, circular economy/life cycle analysis             

Lena Cordie-Bancroft, KS Sector Lead, Medical Devices, BSI

Heidi Barnard, Head of Sustainability, NHS Supply Chain

Clare Atkinson, Director of research & Development, NuGreen

Tracy Parker, Head of shortage management, liaison and transformation, Medical Technologies Directorate, Department of Health and Social Care                                             

Samantha Smith, Director, Product Stewardship & Sustainability, Medtronic

Wendy Rayner, Head of NHS Circular Economy Program, Scottish Government

11.00 – 11.30 Networking Tea/Coffee break

11.30 – 12.15 UK Designated Standards Update, Other Relevant standards e.g. Symbols, Sterilisation, etc

EU Annex Z’s/Standardisation Request/Harmonisation 

Lena Cordie-Bancroft, KS Sector Lead, Medical Devices, BSI

Richard Bancroft, Senior Director, Scientific           

12.15 – 12.45 University Partnerships/Academia         

Emma Glass, University Partnerships Manager - Healthcare, BSI

Dr Irina Brass, Associate Professor, University College London

12.45 – 14.00 Networking Lunch

14.00 – 15.00 Supply Chain, Security of Supply, Multiple marks ie CE, UKCA etc, Economics,        

Helen Forsdyke, Senior Director Enterprise Regulatory Compliance, EMEA, Johnson & Johnson

Sharon Connor, Director Environmental Sustainability, Johnson & Johnson

15.00 – 15.45  Innovation UK plans for future

Dr Camilla Fleetcroft, Strategy & Innovation Director, BSI

15.45 – 16.15  Exploring the MHRA Software Change Programme

Rob Turpin, KS Head of Sector – Healthcare, BSI

Paul Campbell, Head of Software and AI, Innovative Devices Division, MHRA 

Russell Pearson, AI Regulation and Policy Specialist, Innovative Devices Division, MHRA

16.15 – 16.30 Close of Conference              

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

CLOSE OF CONFERENCE  

Pricing

Member ticket: £500

Non member ticket: £1000

BS AAMI 34971:2022 helps medical AI software developers and manufacturers to manage the risks of AI in medical devices effectively and efficiently.

Michael is Director, Medical Technologies EMEAA for Element Materials Testing which is a global testing, inspection, calibration and certification business.  Element work with a broad range of health technology businesses to proactively support them to get to market and manufacture products that are as safe as practically possible.  

Michael is a Director and President Elect of TOPRA (The Organisation for Professionals in Regulatory Affairs).  He is also involved in standards development and member of BSI committee CH/194 Biological evaluation of medical devices.

Graeme is Senior Vice President, Global Regulatory and Quality, Medical Devices at BSI. He has responsibility for BSI’s regulatory compliance to undertake a range of global medical device certification and accreditation activities.

Prior to joining BSI, Graeme was Director of Devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA), where he was responsible for ensuring the safety and performance of medical devices in use in the UK. Graeme first joined the MHRA in 2011 and spent much of his time at the MHRA negotiating and implementing a package of measures to strengthen the regulation of medical devices.

Graeme was a civil servant for nearly 20 years and spent his early career working on healthcare policy. He has previously held Deputy Director roles at the Department of Health and Social Care and spent 18 months as Private Secretary to the Secretary of State for Health.

Graeme has a Master’s degree in biochemistry from the University of Oxford.

Dr. Aris Tzavaras is the Head of Artificial Intelligence NB, BSI group. He has been with BSI since 2018, worked as a BSI Senior Technical Specialist and Scheme Manager within the Active Medical Devices team. As part of his work as Technical Specialist, he has reviewed MDR and MDD active devices including AI software devices. He has more than 20 years’ experience in Medical Devices including Academic lecturing for BSc and MSc Biomedical Engineering programs. He holds a PhD in Health Informatics from City London University on Artificial Intelligence.

Richard is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

A professional with 40 year’s work experience in a scientific background, with 28 years having been spent in Life Sciences, particularly medical devices. Of which 25 years have also been spent in Regulatory Affairs.

And during that time has worked in Research and Development in a pure research facility and a manufacturing facility. Transferring products from an R&D stage into full production. Worked in a joint function of Regulatory and Quality, performed the analysis and interpretation of the MDD, AIMDD, IVD, Medicines, Human Tissues, Biocides and Environmental legislation. Set up new quality systems to meet the impacts & requirements of these regulations. Worked in the external environment with country and regional industry associations, competent authorities and notified bodies to shape the current and future regulatory legislation. Served as the principle contact and spokesperson for communication with Regulatory Agencies and ensure all Regulatory policies, procedures and practices are complaint.

Rachel began her career twenty years ago as a research scientist. Since then, she has held various research and development positions in medical device companies and has experience with clinical investigations.

Joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel holds the position of Clinical Regulatory Lead, where she has a particular focus on the clinical evaluation of active medical devices.

Dr Amie Smirthwaite is SVP, Intelligence & Innovation, for RQM+, the world’s leading MedTech service provider, offering consulting, clinical trial, lab, reimbursement and software solutions.

Amie joined RQM+ in May 2020, following 12 years at BSI, where she was Global Head of Clinical Compliance. She established BSI’s clinical compliance team and led clinical aspects of BSI’s successful designation under MDD, MDR and IVDR. Amie has been involved in numerous expert working groups within the EU, determining requirements for the interpretation and implementation of clinical evidence and postmarket surveillance, and has contributed to many MDCG and MedDev guidance documents, including SSCP, “sufficient clinical evidence”, equivalence, PMCF, and PSURs. She is contributing as Committee Expert for the European Commission Clinical Investigations and Evaluations Working Group.

Lena is the Sector Lead for Medical Devices on BSI’s Knowledge Solutions division, where she is responsible for working with industry and government stakeholders to address challenges surrounding the development and designation of medical devices standards; providing subject matter expertise and thought leadership to strengthen and promote the use of standards to support regulation; and influencing the strategy of healthcare standards through innovation and collaboration with other sectors. Her areas of focus include reprocessing of medical devices, sustainability and circular economy, and artificial intelligence and software as medical devices.

Clare Atkinson is Founder and Director of Research & Development at NuGreen Ltd. Clare is passionate about driving sustainability in healthcare through data driven decisions, specialising in finding ways to measure and monitor scope 3 activities and driving decarbonisation and cost reductions in healthcare by focussing in on the detail of our everyday activities. Clare has a background in science education, corporate sales and medical device distribution.

Emma Glass is the University Partnerships Manager for Healthcare Technologies in the Knowledge Solutions division of the British Standards Institute (BSI). She is responsible for engaging with universities in healthcare technology research and innovation to promote participation and raise awareness of standards and standards development. Recent work includes creating and delivering an interactive workshop for Biomedical Engineering students on the value of standards in healthcare and collaborating with leading healthcare universities on innovative research projects. Prior to working at BSI, Emma launched new open-access science journals in digital health, nuclear medicine and radiology. She also authored CBP’s Big Data Focus Report in 2016 and 2017. Emma has a degree in English Literature from the University of Exeter.

Camilla bringing a wealth of knowledge and experience across the MedTech sector. After qualifying as a medical doctor, she worked for 9 years at the Medicines and Healthcare products Regulatory Agency (MHRA) and recently joined BSI to lead on strategy and innovation within the regulatory Services team. Earlier in the year she supported the UK Government as a champion for the Pro-Innovation Regulation of Technologies Review. Working hand-in- hand with Sir Patrick Vallance & Sir John Bell, the review set out key recommendations to accelerate development and deployment of emerging tech in the UK. 

Russell holds a PhD in bionanotechnology with a focus on the manufacturing and analysis of nanoparticles for drug delivery. For the past 10 years Russell has worked both in the public and private sector with a focus on bringing innovative medical device technologies to the regulated healthcare market. In his role at the Medicines and Healthcare products Regulatory Agency (MHRA) Russell focuses on the regulation of Artificial Intelligence as a Medical Device (AIaMD) for the UK market and the collaboration and alignment with other regulators domestically and internationally as co-chair of the IMDRF AI/ML Working Group with the US FDA.

Paul is a highly respected clinician and expert in the field of healthcare information technology and regulations. After starting his career as a Pharmacist, he transitioned to Medicine and became a Consultant Anaesthetist with over 25 years of experience across multiple clinical and digital domains. 

He has held several clinical NHS and eHealth roles, including as a Clinical Director within the Clinical Informatics team at NHS National Services Scotland and a Clinical Advisor to the Scottish Government Digital Health & Care Department. He is a Founding Fellow of the UK Faculty of Clinical Informatics and a past member of several key regulatory groups, including the Scottish Health Technologies Council.

Having started with the MHRA as the Senior Clinical Advisor at the Software and AI Group, Paul is now the new Head of Software and AI at the MHRA. With his multiple combined backgrounds across industry, the NHS, government and regulations, Dr Campbell is well-equipped to navigate the complex landscape of software and AI regulation within healthcare.

A professional with 40 year’s work experience in a scientific background, with 28 years having been spent in Life Sciences, particularly medical devices. Of which 25 years have also been spent in Regulatory Affairs.

And during that time has worked in Research and Development in a pure research facility and a manufacturing facility. Transferring products from an R&D stage into full production. Worked in a joint function of Regulatory and Quality, performed the analysis and interpretation of the MDD, AIMDD, IVD, Medicines, Human Tissues, Biocides and Environmental legislation. Set up new quality systems to meet the impacts & requirements of these regulations. Worked in the external environment with country and regional industry associations, competent authorities and notified bodies to shape the current and future regulatory legislation. Served as the principle contact and spokesperson for communication with Regulatory Agencies and ensure all Regulatory policies, procedures and practices are complaint.

Helen Forsdyke has been part of for Johnson & Johnson for over 20 years and is currently the Senior Director, Regulatory Compliance, partnering with the Johnson & Johnson commercial entities in EMEA and distribution centres globally to ensure End-2-End Quality Compliance.  As part of the J&J Regulatory Compliance organization, Helen has responsibility for monitoring the external environment, with focus on changing regulations impacting Quality & Compliance, partnering with Regulatory, and Government Affairs in advocacy, and partnering with the business on implementation.

Helen has a strong background in Quality Management Systems, working in Pharmaceutical, Medical Device and Combination Product areas to gain the widest experience of the applicability of Quality System requirements to our products.  Helen has a degree in Applied Biology from The University of Hertfordshire, UK, and has a background in industrial microbiology.  

Richard has over 33 years’ experience in sterilization and medical devices, and is a IHEEM-Registered Authorising Engineer (Decontamination) (AE(D)), has a BSc (Hons) Degree in Applied Chemistry and is a Fellow of the Royal Society of Biology (FRSB) and has been granted 5 patents in USA and other countries.

He is Chairman of ISO/TC 198 and has actively driven international standards for over 25 years. He is the convenor of ISO/TC 198 WG 6, CEN/TC 102 WG 7 and AAMI/ST WG06. He was awarded AAMI’s 2014 Standards Developer Award.

Rob Turpin joined the British Standards Institution (BSI) in 2001 and is currently Head of Sector for Healthcare in the Knowledge Solutions stream.  He leads on the strategic standardization approach for the role that BSI has in supporting policy, productivity and innovation in the healthcare system.  His key area of focus include medical technology, NHS policy and innovation and population health. 

Previously, Rob has been involved in managing national and international standards development programmes across a variety of subject sectors.  He has a degree in Chemical Engineering from the University of Teesside, UK.

Commander (CDR) Neil A. Mafnas is a Senior Program Management Officer on the International Affairs Team, Office of the Center Director, Center for Devices and Radiological Health (CDRH).

As a member of the International Affairs Team, CDR Mafnas collaborates with international stakeholders and CDRH staff to develop and implement harmonized best practices and meaningfully inform one another’s approach to regulatory decision-making.

CDR Mafnas also serves as a subject matter expert on the Medical Device Single Audit Program for CDRH.

Tracy began her Civil Service career as an Internal Auditor, working in the Property Services Agency and the Department of Environment before moving to the Department of Health.  She subsequently spent many years working in the Department’s Cancer Policy Team, managing equipment programmes and as Treatment lead. Moving to Health Protection, Tracy led development and implementation of the UK’s Antimicrobial Resistance Strategy. After a spell supporting development of the Adult Social Care data strategy, she joined the Medtech Directorate in 2021 where she is Head of Shortage Management and Transformation.

This event contributes to UN Sustainable Development Goal 3 on good health and well-being and Goal 12 on responsible consumption and production.