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SMi is proud to announce the launch of their Medical Devices and IVD conference to be held in London in November 2021.

The MDR and IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance. What does this mean for the future of the Medical Devices and IVD industry?

SMi's inaugural Medical Devices and IVD conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these new regulations. In addition, the conference will examine MHRA Guidance on Post-Brexit IVD Regulations and consider the evolving regulatory landscape for digital health software. Join Europe’s leading Medical Device and IVD Conference which will address post-market surveillance and vigilance, clinical evaluations and investigations, medical device regulatory affairs in global markets, and much more.

  • Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements
  • Gain insights from pharma regulatory experts in compliance and companion diagnostics
  • Understand the latest guidance on Post-Brexit IVD Regulations to overcome common challenges, in addition to considering evolving global regulations
  • Examine post-market expectations for surveillance and vigilance of your medical devices
  • Delve into how COVID-19 has impacted the MDR and IVD regulations 


 

Executives, Directors, VPs, Heads, Principals, Managers of:

  • Device Manufacturing
  • Regulatory Affairs
  • IVDR
  • MDR
  • CMC
  • Compliance
  • Risk Management
  • Traceability
  • Vigilance
  • Product Development
  • PFS
  • Combination Products
  • Previous attendees include:

 Adams Business Associates; Alere International; Alere UK (Rebranded from Inverness Medical UK); AstraZeneca; Bayer A G; BIOAXXESS Technology; Biokit S A; BioKit SA; Boehringer Ingelheim Microparts Gmbh; Cambridge Isotope Laboratories Inc.; Euro Diagnostica; Fleet Bioprocessing Ltd; Index Ventures; Innovate UK (formerly:Technology Strategy Board); Integrated Medicines; Irish Medicines Board; Life Technologies; Medical Device Consultancy; National Genetics Reference Lab, Manchester; NHS Innovations London; NHS Institute for Innovation and Improvement; Pharma Ventures; Point-2-Point Genomics Ltd; QuantumDX; Quotient Bioresearch; Roche Diagnostics Ltd; Royal Free Hospital; Scientia Advisors; Simon-Kucher & Partners; Technology Networks; Unilabs France; University of Birmingham; University of Edinburgh;

Conference programme

9:00 Chair's Opening Remarks

9:10 IVDR implementation: State of play, the Notified Body view

Andreas Stange

Andreas Stange, VP, TUV SUD Japan Ltd
View Bio

  • Status of IVDR implementation: Where do we see the bottlenecks
  • Lessons learnt from IVDR certification projects
  • What should manufacturers consider during the remaining time until DoA
  • 9:50 Combination Products: End-to-End Risk Management

    Susan Neadle

    Susan Neadle, Executive Director Head, Combination Products, Devices, IVDs and Digital Health, Amgen
    View Bio

  • Product Development and Lifecycle Management are founded on principles of risk management
  • Key considerations for Risk Management for Combination Products
  • 10:30 Practical implementation of IVDR - learnings on the path towards IVDR readiness

    Julia Riedlinger

    Julia Riedlinger, IVDR Program Lead, Roche Diagnostics
    View Bio

  • Rolling out IVDR across a global company - from IVDR interpretation to placing in the market
  • Establishing teams and processes to deal with a diverse and huge on-market portfolio and continuous product launches
  • Stumbling blocks on the IVDR journey and how they were overcome
  • 11:10 Morning Coffee

    11:40 Preparing for the IVDR

    Claudia Dollins

    Claudia Dollins, Head, Precision Medicine & Companion Diagnostics, Bristol Myers Squibb
    View Bio

  • Preparing for the IVDR: how to best comply with the new regulations
  • How will the pharma industry be affected?
  • Changes to regulatory classification under the IVDR
  • IVDR and clinical trial designs
  • 12:20 Requirements and challenges under the new IVD regulation

    Rolf Thermann

    Rolf Thermann, Teamlead CDx, TÜV Rheinland LGA Products GmbH
    View Bio

  • Regulatory challenges of Companion Diagnostic/Medicine co-development
  • Consultation process: Data requirements to be provided to the Medicinal Authority
  • CDx tumor profiling NGS tests: Many biomarkers, new biomarkers, clinical evidence
  • 13:00 Networking Lunch

    14:00 Regulatory Aspects of Codevelopment of an In Vitro Diagnostic Companion Diagnostic Test with a Therapeutic Product

    Mike Benecky

    Mike Benecky, Senior Director Regulatory Affairs, UCB-group
    View Bio

  • Best Rx/Dx Co-Development Practices
  • IDE regulation of Investigational CDx Tests
  • CDx Test Up-regulation in the EU
  • 14:40 Notified body panel discussion: Reflecting on the EU MDR and IVDR: challenges and opportunities

  • Overview of recent updates in regulation: what are the key changes?
  • Where can bottlenecks be expected?
  • Analysing hurdles to reaching compliance
  • Updates in regulation for clinical investigations
  • Strategies for implementing post-market surveillance
  • Yvonne Ndefo

    Yvonne Ndefo, Chief Clinical Evaluator, NSAI
    View Bio

    Andreas Stange

    Andreas Stange, VP, TUV SUD Japan Ltd
    View Bio

    Stefan Strasser

    Stefan Strasser, Head of Department, Austrian Medicines and Medical Devices Agency (AGES MEA)
    View Bio

    15:20 Afternoon Tea

    15:50 Post-Market Expectations/Surveillance and Vigilance

    Marta Carnielli

    Marta Carnielli, IVD Technical Officer, TUV Sud Gmbh
    View Bio

  • Stricter post-marketing surveillance to fulfil traceability and ensure patient safety 
  • What are the key changes in requirements for post-marketing surveillance and how this should be implemented? 
  • Post-marketing performance follow-up (PMPF) 
  • Incident reporting to competent authorities
  • 16:30 Vigilance under the MDR/IVDR

    Christophe Driesmans

    Christophe Driesmans, Head of the Materiovigilance Entity, Federal Agency For Medicines and Health Products (FAMHP)
    View Bio

  • Modified vigilance/PMS obligations in the MDR/IVDR 
  • New vigilance/PMS obligations in the MDR/IVDR 
  • Eudamed vigilance module
  • National vigilance/PMS obligations (BE example)
  • 17:10 Chair’s Closing Remarks and Close of Day One

    9:00 Chair's Opening Remarks

    9:10 Practical considerations for implementing the MDR updates

    Vikas Jaitely

    Vikas Jaitely , Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck
    View Bio

  • Overview of key changes in the EU MDR
  • Practical considerations for implementing changes
  • Achieving sufficient clinical evidence for future EU MDR compliance
  • Reflecting on the 2021 EU MDR update: lessons learnt
  • Strategies for working alongside global regulators
  • 9:50 Transitioning from MDD to MDR – opportunities and challenges

    Melanie Donguy

    Melanie Donguy, Head Of Regulatory Affairs EMEA, Bayer Radiology
    View Bio

  • Implementation of the economic operators structure- Organizational impact
  • Labelling updates and product supply management
  • Stakeholders challenges and relationship (EU commission/CA/NBs/ manufacturers) 
  • Common approaches, harmonization, 1 EU repository for medical devices?
  • 10:30 Impact of Article 117 on Non-Integral Drug Device Combinations

    Louise Place

    Louise Place, Director, Devices, GlaxoSmithKline
    View Bio

  • How does Article 117 impact Non-Integral Drug Device Combination products that are ‘Co-packed’ or ‘Cross-Labelled’
  • Available EMA guidance
  • Labelling Requirements and other considerations
  • 11:10 Morning Coffee

    11:40 Impact of Article 117 MDR on medicinal products with an integral medical device

    Silke Conrad

    Silke Conrad, Quality Project Lead Medical Devices, Novartis Pharma AG
    View Bio

  • Impact on new marketing authorization applications
  • Available EMA guidance related to Article 117
  • How much clinical data is required?
  • 12:20 Regulation (EU) No. 2017/745 – Changes for clinical investigations

    Stefan Strasser

    Stefan Strasser, Head of Department, Austrian Medicines and Medical Devices Agency (AGES MEA)
    View Bio

  • Transitional provision and managing the change from MDD to MDR
  • Strategy for the National process and interaction with Ethics Committees
  • Key changes in study types and submission processes
  • Changes for amendments, notifications and safety reporting in the study life-cycle

     

  • 13:00 Networking Lunch

    14:00 Medical Device regulations: strategies for compliance

    James Leamon

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
    View Bio

  • Working with Notified Bodies and External SMEs propels the end point expectations for MDR 2017/745 Article 117 compliance 
  • Related guidance for combination products: ICH Q1A/Q6A/Q8/Q9/Q10; ISO 10993/11135/11608/14971; FDA Guidance and 21 CFR Part 4, 820
  • Integral/Cross-Labelled/Co-Packaged device/drug Combination Product: What do I have?
  • Jazz Pharmaceutical’s initial strategies to expand the QMS to meet regulations
  • 14:40 Engaging the workforce in a successful MDR journey: Discover how Merck Connected Health & Devices engaged its entire workforce into the MDR journey and their successful path to CE mark

    Marc Moal

    Marc Moal, Director, Head of Product Delivery & Project Management Officer at Connected Health & Devices, Merck Group
    View Bio

  • Engaging beyond the quality function
  • Engaging leadership & middle management
  • Engaging 3rd parties successfully
  • Engaging supporting functions
  • Engaging in the physical implementation
  • 15:20 Afternoon Tea

    15:50 Cybersecurity Updates from the FDA

    Jessica Wilkerson

    Jessica Wilkerson, Cyber Policy Advisor, FDA
    View Bio

  • Discussion of the following priority issues that FDA is working on:
  • Legacy devices/technologies: old, outdated, or otherwise unsupported technologies in healthcare are difficult, if not impossible to secure. FDA is working internally and externally on strategies to address.
  • SBOM/Software Supply-Chain: medical devices, like all technology products, inherit risks and vulnerabilities from their supply-chains. These risks and vulnerabilities must be address, and the sector is working to develop and deploy strategies.
  • Vulnerability Communications: while the sector is maturing in its handling of cybersecurity issues generally, its ability to communicate about its maturity and the way that its handling vulnerabilities can be lacking. Patients, industry, and the FDA all recognize that we must improve, and are working to do so.
  • 16:30 Development of Medical Devices: A Toxicologists Perspective

    Clemens Gunther

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG
    View Bio

  • Mastering the biocompatibility program 
  • How to comply with requirements on Extractable & Leachable testing
  • Strategies to generate the Toxicological Risk Assessment
  • 17:10 Chair’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andreas Stange

    Andreas Stange

    VP, TUV SUD Japan Ltd
    Christophe Driesmans

    Christophe Driesmans

    Head of the Materiovigilance Entity, Federal Agency For Medicines and Health Products (FAMHP)
    Claudia Dollins

    Claudia Dollins

    Head, Precision Medicine & Companion Diagnostics, Bristol Myers Squibb
    Clemens Gunther

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    James Leamon

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    Jessica Wilkerson

    Jessica Wilkerson

    Cyber Policy Advisor, FDA
    Julia Riedlinger

    Julia Riedlinger

    IVDR Program Lead, Roche Diagnostics
    Louise Place

    Louise Place

    Director, Devices, GlaxoSmithKline
    Marc Moal

    Marc Moal

    Director, Head of Product Delivery & Project Management Officer at Connected Health & Devices, Merck Group
    Marta Carnielli

    Marta Carnielli

    IVD Technical Officer, TUV Sud Gmbh
    Melanie Donguy

    Melanie Donguy

    Head Of Regulatory Affairs EMEA, Bayer Radiology
    Mike Benecky

    Mike Benecky

    Senior Director Regulatory Affairs, UCB-group
    Rolf Thermann

    Rolf Thermann

    Teamlead CDx, TÜV Rheinland LGA Products GmbH
    Silke Conrad

    Silke Conrad

    Quality Project Lead Medical Devices, Novartis Pharma AG
    Stefan Strasser

    Stefan Strasser

    Head of Department, Austrian Medicines and Medical Devices Agency (AGES MEA)
    Susan Neadle

    Susan Neadle

    Executive Director Head, Combination Products, Devices, IVDs and Digital Health, Amgen
    Vikas Jaitely

    Vikas Jaitely

    Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck
    Yvonne Ndefo

    Yvonne Ndefo

    Chief Clinical Evaluator, NSAI

    Andreas Stange

    VP, TUV SUD Japan Ltd
    Andreas Stange

    Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line. Based in Japan, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.
    Dr. Stange joined TÜV SÜD in 2001 as medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he was President & CEO of TÜV SÜD in Japan.

    Christophe Driesmans

    Head of the Materiovigilance Entity, Federal Agency For Medicines and Health Products (FAMHP)
    Christophe Driesmans

    Graduated as an electromechanical engineer, Christophe started in July 2014 as an assessor at the FAMHP. Since December 2015, he leads the entity responsible for the vigilance of medical devices. He is the expert on vigilance in FAMHP’s transition towards the medical device regulations.
    Christophe is Belgian’s MDCG Nomenclature and MDCG post-market surveillance & vigilance member. He also participates in the MDCG Eudamed and the ad-hoc Eudamed Vigilance workgroup. He has participated in numerous European working groups that aim to improve and formalize the reporting of vigilance cases and the European cooperation between competent authorities.

    Claudia Dollins

    Head, Precision Medicine & Companion Diagnostics, Bristol Myers Squibb
    Claudia Dollins

    Dr. Dollins currently heads the Global Regulatory Affairs team, Precision Medicine and Companion Diagnostics at Bristol-Myers Squibb. Before joining BMS, she was responsible for the development and implementation of global regulatory strategies of companion diagnostics, medical devices and digital health products in the Merck Healthcare KGaA pipeline.
    She further served as a senior reviewer and acting chief of the hematology branch of the Office of In Vitro Diagnostics and Radiologic Health at the FDA.

    Dr. Dollins holds a PhD in Genetics and Genomics from Duke University Medical Center and completed postdoctoral training in Developmental Biology at the University of North Carolina, Chapel Hill.
     

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Clemens Gunther

    Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
    He started his professional career in 1990 at Schering AG, Berlin-Germany.
    From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
    After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.
    Meanwhile Dr. Clemens Günther has gained over 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products in various medical indications.

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    James Leamon

    Jim is a medical device and drug device combination product development leader, an engineering director, and a manufacturing manager. He is experienced in working across functions and business groups in varying organizations. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control and manufacturing processes. Jim continues to lead product development, and contract engineering teams while working at Jazz Pharmaceuticals. He is highly experienced and proficient in CMC drug-device combination product leadership as well as strategic planning, design engineering, manufacturing sciences and engineering and new product and process development. Currently, he is working with Jazz manufacturing teams to expand the availability of a current small cell lung cancer drug product that is in high demand.

    Jim is also a community leader in social justice and feeding the hungry. As treasurer of a non-profit organization, he has used his strategic planning and financial management skills to help people in need. This correlates well with his career drive to improve the lives of cancer patients and those with other life threatening diseases.

    Jessica Wilkerson

    Cyber Policy Advisor, FDA
    Jessica Wilkerson

    Jessica Wilkerson is a Cyber Policy Advisor with the All Hazards Readiness, Response, and Cybersecurity (ARC) team in the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). As part of ARC, she examines issues and develops policy related to the safety and effectiveness of connected medical devices. She received a B.A. in Policy Studies and minors in Computer Science and Mathematics from Syracuse University, and is currently pursuing a J.D. from the Catholic University of America’s Columbus School of Law.

    Julia Riedlinger

    IVDR Program Lead, Roche Diagnostics
    Julia Riedlinger

    Dr. Julia Riedlinger is leading the IVDR program for Roche Diagnostics. In this role she is responsible for the coordination of all IVDR required activities (processes & product transition) across the different Customer Areas, global functions and sales affiliates. Prior to taking the project leader role, she worked 11 years in R&D for Centralised and Point of Care Solutions (former Business Area of Roche Diagnostics) setting up the biobank for early biomarker discovery and working on internal as well as external biomarker discovery and validation programs. Julia Riedlinger is a pharmacist with a PhD in pharmaceutical biotechnology from the Ludwig-Maximilians University (LMU) in Munich.

    Louise Place

    Director, Devices, GlaxoSmithKline
    Louise Place

    Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
    Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
    With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

    Marc Moal

    Director, Head of Product Delivery & Project Management Officer at Connected Health & Devices, Merck Group
    Marc Moal

    Marc Moal is Director of Product Delivery & PMO at Merck Group leading a team of project directors developing connected injection devices and supporting web platform/mobile applications to support 43% of Merck drug sales. Previously, he held several leading positions in Nespresso such as Global Head of Quality & After Sales and Global Head of Contract Manufacturing managing overseeing the operational aspects of the 10 million coffee machines produced every year for the group. Before Nespresso, he was Engineering Director at Heraeus Medical Components (Stylets, Coils, Stents) and Project Manager of large projects at Medtronic (class 3 medical devices industrialization, new factory in Singapore…).
    He received his Master’s Degree in Electrical Engineering from the ISEN (Institut d’Electronique du Nord – Lille) in 2001 and started his career in the semiconductor industry in the Swatch group, RFID division. He also hold a PMP as well as a Certificate of Advanced Studies in Medtech&Biotech from EPFL – Lausanne.

    Marta Carnielli

    IVD Technical Officer, TUV Sud Gmbh
    Marta Carnielli

    Marta Carnielli works for TUV SUD as IVD Technical Officer; in this role, she is responsible to gather and distribute regulatory information in the IVD field, represent TÜV SÜD in relevant regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group

    Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department.
    In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.

    Melanie Donguy

    Head Of Regulatory Affairs EMEA, Bayer Radiology
    Melanie Donguy

    Mélanie Donguy holds a Pharm D from René Descartes Paris V University and a Master degree in Microbiology . After several years spent in the Pharma Industry within Sanofi, she joined Medtronic in 2010 in regulatory function supporting different business units and being responsible of the implementation of the medical device regulation in EMEA region. She is a subject matter expert in drug device combination products, sterilization and clinical European regulations. Since June 2019 she joined Bayer Radiology as Regulatory Head of medical devices EMEA.

    Mike Benecky

    Senior Director Regulatory Affairs, UCB-group
    Mike Benecky

    Michael Benecky is currently Senior Director, Global Regulatory Affairs at UCB Pharmaceutical located in Research Triangle Park, North Carolina. In his current position, Mike leads the development of IVD/Companion Diagnostic Regulatory strategy for a number of UCB rare disease drug assets that require autoantibody tests for patient selection. Prior to UCB, Mike spent 9 years at GlaxoSmithKline where he was Senior Director, Precision and Digital Medicine developing regulatory strategy for companion diagnostic tests supporting oncology and infectious disease therapeutic products. Mike obtained his Ph.D in biophysical chemistry from Princeton University and his B.A. in Biochemistry from the University of Wisconsin-Milwaukee. Mike also has extensive academic and industrial research and product development experience interfacing biology, chemistry, physics and engineering.

    Rolf Thermann

    Teamlead CDx, TÜV Rheinland LGA Products GmbH
    Rolf Thermann

    Dr. Rolf Thermann is currently a Lead Auditor, Technical Expert and Team Leader Companion Diagnostics at the Notified Body TÜV Rheinland LGA Products GmbH. Within the IVD department he is responsible for regulatory support of Companion Diagnostic products throughout the entire conformity assessment process and interactions with the relevant stakeholders. Dr. Thermann holds a PhD in molecular Medicine and worked in the Pharmaceutical Industry on Antiviral Drug development and in the IVD Industry on the development of PCR-Assays for blood donation testing.

    Silke Conrad

    Quality Project Lead Medical Devices, Novartis Pharma AG
    Silke Conrad

    Silke Conrad is currently Quality Project Lead for Medical Devices at Novartis Pharma AG. In her current role, she mainly supports medical devices and combination products from a QA perspective, negotiates and approves QA agreements and establishes and maintains QA processes for medical device development. Silke joined Novartis in 2011 as Regulatory CMC Associate Director for Biologics from the medical devices company Ypsomed AG/Switzerland, where she was leading the regulatory affairs department.
    Prior to Ypsomed AG, Silke worked for Sanofi-Aventis in Frankfurt/Germany and Holmes Chapel/UK holding different positions in Regulatory Affairs and Quality Assurance with main focus on biotech/biological products and combination products.
    Silke is a food chemist/environmental toxicologist from education and holds a doctorate degree in molecular biology/cancer research from the Technical University of Kaiserslautern/Germany.

    Stefan Strasser

    Head of Department, Austrian Medicines and Medical Devices Agency (AGES MEA)
    Stefan Strasser

    Stefan Strasser trained as a medical doctor at the Medical University of Innsbruck in Tirol, Austria. Since 2009 he works as a clinical assessor for the Austrian Medicines and Medical Devices Agency (AGES MEA). Since 2019 he holds the position of head of the department of clinical trial and is in charge for the operational implementation of the Clinical Trials Regulation and the Medical Devices Regulation for aspects of clinical trials. He further acts as an Austrian representative to several European working groups on clinical trials for medicines and medical devices.

    Susan Neadle

    Executive Director Head, Combination Products, Devices, IVDs and Digital Health, Amgen
    Susan Neadle

    Susan Neadle serves as Head of Combination Products, Devices, Diagnostics & Digital Health Regulatory Affairs at Amgen. Prior to her current role, Susan enjoyed more than 25 years at Johnson & Johnson, where she held integral leadership roles in Research & Development and Quality Engineering, spanning medical devices, pharmaceuticals, consumer products and the Enterprise. In her most recent role there, Sr. Director, Global Value Chain Quality Design, she served as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations at Janssen, J&J’s Pharmaceutical sector. She was awarded the Janssen Supply Chain Inclusion Award in recognition of her global cross-functional leadership and collaboration. Susan is a Design & Process Excellence Blackbelt, and has applied those skills to drive and develop impactful new products and positive business outcomes, for which she was awarded the Johnson Medal, J&J’s highest honor for excellence in Research & Development. She holds numerous patents and publications, and frequently speaks in public venues. Susan is actively engaged in multiple industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, DIA and PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice, and as Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry. Susan has also been very active in Workforce of the Future, collaborating with University of Maryland, FDA, and other cross-industry subject matter experts to establish and teach a curriculum in Combination Products.

    Vikas Jaitely

    Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck
    Vikas Jaitely

    Vikas Jaitely is a pharmacist with a Ph.D. in pharmaceutics and drug delivery systems. He ha more than 17 years of experience working in the pharmaceutical industry. Jaitely joined Merck KGaA,Darmstadt, Germany in 2017 from the UK Medicine and Healthcare products Regulatory Agency (MHRA) where he worked as a senior assessor and team manager. He was awarded the Maplethorpe Fellowship by University College London for his work on drug-delivery systems and has authored 23 original research papers in peer-reviewed journals.

    Yvonne Ndefo

    Chief Clinical Evaluator, NSAI
    Yvonne Ndefo

    Dr Yvonne Ndefo is the Chief Clinical Evaluator of National Standards Authority of Ireland, where she is responsible for the oversight of the clinical assessment of medical devices technical documentation, managing a team of medical doctors who review the clinical evidence submitted by medical device manufacturers.

    Yvonne is a Medical Doctor has been a first-hand end user to a wide range of medical devices. She also holds a Master of Surgery degree from the National University of Ireland, Galway.

    Dr Yvonne is committed to the assessment of Clinical Evaluation Reports, Clinical Investigations, Post Market surveillance data, including Post Market Clinical Follow up data, and other relevant supporting clinical evidence necessary for the demonstration of safety and performance of medical devices.
     

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    Workshops

    Implementing the EU MDR and Article 117, an industry perspective
    Workshop

    Implementing the EU MDR and Article 117, an industry perspective

    Venue To Be Confirmed
    17th November 2021
    London, United Kingdom

    VENUE

    Venue To Be Confirmed

    London, United Kingdom

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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