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SMi’s Inaugural Conference
Medical Wearables for Biosensors
October 25-26, 2021 | Virtual Conference: Online Access Only
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SMi is proud to present the Medical Wearables for Biosensors Conference, taking place on the 25th - 26th October 2021.

The global wearable biosensors market is a rapidly expanding industry with increasingly growing potential for applications in healthcare and technological advances. With potential in remote patient monitoring, diagnosis and detection of disease, biosensors and wearable devices are gaining substantial interest due to their opportunities to offer continuous and reliable physiological information allowing for better support of patient needs.

 

As part of SMi’s leading series of medical device conferences, this year’s event will be exploring therapeutic applications of connected on-body devices, bringing insights into on-body devices for monitoring and remote diagnostics, device design considerations and wearables in clinical trials. Furthermore, this year’s event will uncover the role that biosensors have played in the response against COVID-19 in addition to a future outlook of the industry, highlighting rapidly growing start-ups and novel developments in the industry.
 

  • Engage in case studies from leading experts on wearable devices for remote diagnostics and patient monitoring 
  • Explore how industry is using on-body biosensors for a patient centric-approach to therapeutics
  • Uncover how medical wearables and digital health technologies are advancing the potential of clinical trials
  • Delve into the evolving research into smart vaccines for COVID-19 and accelerating accessibility of new wearable technologies

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

  • Digital health and connectivity
  • Smart device developers
  • Device manufacturers
  • Biosensors
  • Wearable devices
  • Connected Devices
  • Microneedle Patches
  • Human Factors 
  • Packaging 
  • Regulatory Affairs 
  • Medical Device Data

Conference programme

8:30 Registration & Coffee

9:00 Chairs' Opening Remarks

Andreas Caduff

Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
View Bio

Natalie Wisniewski

Natalie Wisniewski, Principal, Medical Device Consultancy
View Bio

9:10 Bringing medical wearables into people’s homes

Andreas Caduff

Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
View Bio

  • What elements do you need to master to operate a medical wearable ecosystem
  • An outlook into sustainability and connectivity – the meaning of data analyses and illustration
  • The business case challenges for new wearable devices
  • The next steps for providing increased availability of medical wearables for patients
  • 9:50 Digital Innovation within clinical trials

  • How the landscape has changed over the past 12 months
  • How remote technology has improved the patient experience
  • Digital Integration of Clinical Assessments
  • Gary McNamara

    Gary McNamara, Senior Delivery Manager, Aparito
    View Bio

    Sandra Komarzynski

    Sandra Komarzynski, Data Scientist, Aparito
    View Bio

    10:30 Morning Coffee

    11:00 Wearable remote patient monitoring to explore brain-heart links

  • American Heart Association’s health technologies and innovation initiative
  • Examining connections between heart and brain health for dementia and Alzheimer’s disease research
  • How AI and computer analytics are being to monitor early behaviours leading to chronic diseases
  • How passive data collection can enable more sustainable and diverse studies in the future
  • Rhoda Au

    Rhoda Au, Professor, Anatomy and Neurobiology and Neurology, Boston University School of Medicine
    View Bio

    Vijaya Kolachalama

    Vijaya Kolachalama, Assistant Professor, Boston University School of Medicine
    View Bio

    11:40 Liquid Crystal Polymers for Connected Medical Devices

    Philip Wilson

    Philip Wilson, Marketing Director, Engineered Materials, Celanese
    View Bio

  • Liquid Crystal Polymers (LCP) enable miniaturization of connected medical devices.
  • LCP properties are ideally suited to high-volume manufacturing.
  • Electronic properties of LCP can be tailored for use as antenna substrates for electronics integration.
  • Celanese LCP can be provided with regulatory support needed for FDA approvals

     

  • 12:20 On-body biosensors: A human factors development approach

    James Leamon

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

  • What’s new in On-Body Biosensor Technology
  • Meeting the needs by being Patient Centric
  • Updated Human Factors regulation
  • Biosensor Life Cycle Management embraces cutting edge Innovation
  • 13:00 Networking Lunch

    14:00 Technology and design considerations in developing easy-to-adopt user centric digital health products

    Jason Song

    Jason Song, Chief Technology Officer, SureMed Technologies, Inc.
    View Bio

  • Creating easy to adopt user centric products through smart utilization of sensor and technology fundamentals
  • Software update considerations and minimize life cycle management complexity
  • Understand societal and behaviour imprints to develop solutions with easier adoption and simple learning curve for patient
  • User centric design considerations in product design beyond the patient
  • 14:40 Wireless implantable sensors for cardiovascular applications

    William G Hendren

    William G Hendren, CEO, Qura Inc
    View Bio

  • Implantable technologies 
  • QURA’s unique design concept and attributes
  • Application landscape
  • Data driven therapeutics
  • 15:20 Smart patches for COVID-19 vaccine delivery and efficacy monitoring

    Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

  • Examples of microneedle patches currently used for vaccine delivery 
  • Enabling transdermal biomarker monitoring with minimal invasion
  • Data considerations of a real-time platform
  • The potential for future vaccine efficacy trials
  • 16:00 Afternoon Tea

    16:30 Developing smart on-body sensors via on-skin printing

    Huanyu (Larry) Cheng

    Huanyu (Larry) Cheng, Dorothy Quiggle Assistant Professor, Penn State University
    View Bio

  • How a universal fabrication scheme has been developed to enable printing of nanoparticles on the skin
  • Electromechanical performance and monitoring potential
  • Opportunities for symptom monitoring including for COVID-19
  • Challenges in altering the technology for specific and precise target applications
  • 17:10 Utilising connected devices to combat COVID-19: Case studies

    Alex Gilbert

    Alex Gilbert, Digital Medicine, Huma
    View Bio

  • Huma’s experience tackling COVID-19
  • Integration of spirometry and connected thermometers
  • Procurement and distribution during a pandemic
  • Outcomes of utilising digital health and connected devices
  • 17:50 Chairs' Closing Remarks and Close of Day One

    Andreas Caduff

    Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
    View Bio

    Natalie Wisniewski

    Natalie Wisniewski, Principal, Medical Device Consultancy
    View Bio

    8:30 Registration & Coffee

    9:00 Chairs' Opening Remarks

    Andreas Caduff

    Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
    View Bio

    Natalie Wisniewski

    Natalie Wisniewski, Principal, Medical Device Consultancy
    View Bio

    9:10 Evolving digital clinical evidence generation: A series of step changes

    Janeta Nikolovski

    Janeta Nikolovski, Director, Innovation, Janssen R&D
    View Bio

  • The pathway to the Heartline study
  • How the remote study is working towards a fundamental change in our understanding of digital tools through direct patient engagement
  • Applying behavior science in designing an integrated user experience
  • Beyond Heartline – what is next and emerging?
  • 9:50 Night-time scratching and sleep: The use of digital health technology to quantitatively measure key components of atopic dermatitis

    Carrie Northcott

    Carrie Northcott, Director and Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD), Pfizer Inc
    View Bio

  • Digital Health Technologies (DHT) provide an opportunity to gain perspectives on endpoints that have been traditionally difficult to measure using standard measures, such as night-time scratch and sleep.
  • The validation of electronic data capture system and software facilitated the development of wrist worn sensor(s) and novel analytical approaches that have enabled sleep and scratch patterns to be measured remotely and quantified based on sensor recordings of patient behaviors. 
  • The overall goal of this research is patient focused; measuring endpoints meaningful to patients that they cannot directly report due to the fact the symptoms (night-time scratch and sleep disturbances) occur during the nighttime period; moreover, the need to enable better treatments and understanding of the condition.
  • 10:30 Morning Coffee

    11:00 Medical grade wearables for continuous health monitoring and clinical intelligence

    James Mault

    James Mault, Founder and CEO, BioIntelliSense, Inc.
    View Bio

  • The new era of continuous health monitoring and the tenants for making remote patient monitoring ubiquitous and scalable
  • Medical grade clinical accuracy matters 
  • The power of data science to enable early detection
  • How advanced biosensor technology and analytics is enabling medical grade care at home
  • 11:40 Connected health value creation

    David Braun

    David Braun, Global Head of Connected Health and Devices Business Solutions, Merck Group KgAa
    View Bio

  • Connected health and devices examples
  • Design thinking and value creation
  • Lessons learned, challenges and opportunities
  • 12:20 Networking Lunch

    13:20 When Biosensors Meet Clothing: Truly Wearable Sensors Improve Women's Cardiovascular Health

    Alicia Chong Rodriguez

    Alicia Chong Rodriguez, CEO, BloomerTech
    View Bio

  • The landscape of cardiovascular diseases and diagnosis
  • The lack of female patient data and the power of data to improve diagnosis
  • An insight into Bloomer Tech’s sensor technology for personalized healthcare
  • How can we expect sensor technology to further accelerate progress in women’s health?
  • 14:00 Digital therapeutics at MedRhythms: Targeting the motor system to improve walking

    Owen McCarthy

    Owen McCarthy, President, MedRhythms
    View Bio

  • Discover how you combine sensors, software, and music to drive therapeutic outcomes
  • Review initial data from the MedRhythms chronic stroke product 
  • Discuss applicability across a pipeline of neurologic injuries and diseases
  • 14:40 Afternoon Tea

    15:10 Vibrant Aging: On the Forefront of Connected Health for Seniors

    Andrew Broderick

    Andrew Broderick, Research Director, Center for Aging Research and Accessibility, Focus Academy
    View Bio

  • Bridging the digital divide in an era of age-friendly tech and challenging care needs
  • Real-world technology use and design factors with developing age-friendly solutions
  • From wearables to hearables: future outlook for age-friendly connected health technologies
  • Strategies to advance age-friendly innovations toward commercialization
  • 15:50 ASSIST On the Cutting Edge: Advanced Self-Powered Systems of Integrated Sensors and Technologies

    Veena Misra

    Veena Misra, Distinguished Professor, Director , NSF Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies(ASSIST)
    View Bio

  • An introduction to the Assist Centre’s mission to create self-powered sensing systems
  • Insights into the advanced power of harvesting technologies and ultra-low power electronics and sensors
  • Benefits of self-powered wearable sensor devices to increase adoption, compliance and advance long-term sensing for chronic conditions
  • How can we expect advanced self-powered systems to feature in future medical wearable device technologies?
  • 16:30 Panel Discussion: Evolving digital medicine opportunities for connected devices

  • With growing adoption of on-body wearable technology and medical biosensors we are seeing evolving therapeutic applications for this technology
  • An outlook of the growing opportunities of data in enhancing patient care and diagnostics
  • Insights into new therapeutical applications of biosensors and emerging uses for connected devices
  • How industry can accelerate connected device potential with patients at the forefront
  • Andreas Caduff

    Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
    View Bio

    Natalie Wisniewski

    Natalie Wisniewski, Principal, Medical Device Consultancy
    View Bio

    Owen McCarthy

    Owen McCarthy, President, MedRhythms
    View Bio

    Andrew Broderick

    Andrew Broderick, Research Director, Center for Aging Research and Accessibility, Focus Academy
    View Bio

    Alicia Chong Rodriguez

    Alicia Chong Rodriguez, CEO, BloomerTech
    View Bio

    Veena Misra

    Veena Misra, Distinguished Professor, Director , NSF Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies(ASSIST)
    View Bio

    17:10 Chairs' Closing Remarks and Close of Day Two

    Andreas Caduff

    Andreas Caduff, Strategic Advisory Board, Digital Medicine Society
    View Bio

    Natalie Wisniewski

    Natalie Wisniewski, Principal, Medical Device Consultancy
    View Bio

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    FEATURED SPEAKERS

    Alex Gilbert

    Alex Gilbert

    Digital Medicine, Huma
    Alicia Chong Rodriguez

    Alicia Chong Rodriguez

    CEO, BloomerTech
    Andrew Broderick

    Andrew Broderick

    Research Director, Center for Aging Research and Accessibility, Focus Academy
    Carrie Northcott

    Carrie Northcott

    Director and Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD), Pfizer Inc
    Daniel Lewi

    Daniel Lewi

    Head of Business Development, Aparito
    David Braun

    David Braun

    Global Head of Connected Health and Devices Business Solutions, Merck Group KgAa
    Gary McNamara

    Gary McNamara

    Senior Delivery Manager, Aparito
    George Cusatis

    George Cusatis

    Director, Regulatory Affairs, Merck
    Huanyu (Larry) Cheng

    Huanyu (Larry) Cheng

    Dorothy Quiggle Assistant Professor, Penn State University
    James Leamon

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    James Mault

    James Mault

    Founder and CEO, BioIntelliSense, Inc.
    Janeta Nikolovski

    Janeta Nikolovski

    Director, Innovation, Janssen R&D
    Jason Song

    Jason Song

    Chief Technology Officer, SureMed Technologies, Inc.
    Natalie Wisniewski

    Natalie Wisniewski

    Principal, Medical Device Consultancy
    Owen McCarthy

    Owen McCarthy

    President, MedRhythms
    Philip Wilson

    Philip Wilson

    Marketing Director, Engineered Materials, Celanese
    Rhoda Au

    Rhoda Au

    Professor, Anatomy and Neurobiology and Neurology, Boston University School of Medicine
    Sandra Komarzynski

    Sandra Komarzynski

    Data Scientist, Aparito
    Sanjiv Sharma

    Sanjiv Sharma

    Senior Lecturer in Medical Engineering, Swansea University
    Veena Misra

    Veena Misra

    Distinguished Professor, Director , NSF Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies(ASSIST)
    Vijaya Kolachalama

    Vijaya Kolachalama

    Assistant Professor, Boston University School of Medicine
    William G Hendren

    William G Hendren

    CEO, Qura Inc

    Alex Gilbert

    Digital Medicine, Huma
    Alex Gilbert

    Alex has worked within the Digital Health industry for a number of years alongside healthcare, pharmaceutical and tech organisations. He joined Huma as one of their first employees and currently manages global Life Sciences Partnerships. Huma is one of the UK’s highest-growth digital health companies, having raised over 50 Million in funding, whilst partnering with Apple and Tencent. His passion is the use of technology to empower and engage the patient to take control of their care.

    Alicia Chong Rodriguez

    CEO, BloomerTech
    Alicia Chong Rodriguez

    Alicia Chong Rodriguez is the CEO at Bloomer Tech. She graduated from the MIT Electrical Engineering & Computer Science program and MIT IDM, where her research focused on sex-specific, computationally-generated, cardiac biomarkers at the MIT Computational Cardiovascular Research Group. She received the MIT Legatum Fellowship and the MIT Graduate Women of Excellence Award. She has also been recognized as a 2018 Medtech Boston 40 under 40 Healthcare Innovator, and in the top 100 Female Founders across the U.S. by Inc Magazine. Prior to MIT she worked in the semiconductor industry at companies such as HP and Teradyne and co-founded MenTe en Acción (Mujeres en Tecnología) where she currently serves on the board as a technical advisor

    Aceil Halaby is the COO at Bloomer Tech. She has a Bachelor of Fine Arts degree in industrial design from RISD and graduated from the MIT Integrated Design & Management master's program. Her thesis at the MIT Center for Collective Intelligence focused on highly productive product teams. She has won the Harvard Arab pitch competition, HITLAB's Women's Health Tech Challenge, and led Bloomer Tech to become part of the top 20 of MassChallenge finalists. She has also been recognized and interviewed by Forbes, MIT Tech Review, Cheddar and Bostinno.

    Aceil Halaby and Alicia Chong Rodriguez are the founders of Bloomer Tech. The company is ushering in a new age of personalized healthcare, disease prevention, and management. Using patented augmented clothing and novel digital biomarkers, Bloomer Tech works with providers to reduce high rates of hospital readmissions, undertreatment, and underdiagnosis that can cause sudden deaths in often overlooked populations. Their vision is to increase access and inclusivity in cardiovascular research and treatment without changing a woman's lifestyle or leaving her health to chance.

    The Bloomer Tech founders met at MIT and became the first venture funded startup focused on solutions for cardiovascular disease and stroke in women. Their patented technology platform leverages more than 20 years of evidence-based research showing sex and ethnicity-related differences in the cardiovascular system. This enables women, researchers, and care providers to learn from each individual's unique physiology and provide data-driven care remotely. The company was named to the Forbes list of 50 Women-Led Startups That Are Crushing Tech.
     

    Andreas Caduff

    Strategic Advisory Board, Digital Medicine Society
    Andreas Caduff

    Andreas Caduff has been a driving force in the development of non-invasive and contextualized physiological monitoring. He was serving as CTO of Solianis where he orchestrated the development of non-invasive glucose monitoring. He then founded Biovotion and served for 7 years as CEO, offering a state of the art user-centric, analytics driven ecosystem, powered by medical wearable technology. Biovotion received several international awards and high calibre endorsements for its innovations, including an award from the XPrize Foundation. Today he is working at the interface of secured medical technology, physiological monitoring and data science, towards a more holistic view of health.

    Andrew Broderick

    Research Director, Center for Aging Research and Accessibility, Focus Academy
    Andrew Broderick

    Andrew’s research interests focus specifically on the transformation of consumer health through innovation, technology and strategy. Andrew currently serves as Research Director at Focus Academy, a thriving startup community designed to move innovation forward and works with the San Francisco Tech Council to advance its work to promote digital inclusion for older adults. Andrew’s extensive experience includes the evaluation and assessment of digital health solutions for underserved populations, leading user experience research, and conducting focus groups and interviews with key opinion leaders across the healthcare continuum. Previously, Andrew served as Research Director at the Health Technology Center in San Francisco where he was responsible for tracking and assessing emerging technologies and their long-term clinical and financial impact on hospital operations. Prior to that, Andrew led consulting projects at SRI International for Fortune 500 clients.

    Carrie Northcott

    Director and Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD), Pfizer Inc
    Carrie Northcott

    Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer. She leads a driven and diverse team that is evaluating and validating the use of wearable digital devices to more fully understand and characterize physiological endpoints, such as quantitatively measuring night-time scratch and sleep. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides unique insight into understanding how these novel digital endpoints provide meaningful information to patients, doctors and researchers to better treat and understand diseases.

    Daniel Lewi

    Head of Business Development, Aparito
    Daniel Lewi

    Daniel has first-hand experience of caring for a family member with a rare disease after his daughter was diagnosed with Tay-Sachs in 2011. As the founder of the rare disease charity The Cure & Action for Tay-Sachs (CATS) Foundation, he is fully aware of the challenges that many families face when taking part in clinical trials whilst also juggling their day to day life.

    David Braun

    Global Head of Connected Health and Devices Business Solutions, Merck Group KgAa
    David Braun

    David Braun is Global Head of Medical Device Business Solution for Merck Healthcare. David is an executive leader that has 20 years of experience in research and development, operations, strategy and business management working in Europe, USA and Asia, in startups and large multinational companies. Through his career David gained significant experience designing winning organizations, leading and coaching cross functional teams bringing innovative products from ideation to launch. David is actually a Board director of Cellect, a biotech startup active in the field of stem cells and medical devices.

    Before joining Merck, David served as Head of Operations and Global R&D of the Technology Business unit at Newell Brands, a Fortune 500 company, where he led key growth initiatives and multimillion dollar projects.

    Prior to that, he worked as Vice President of R&D and Operations at Biosafe SA a medical device company recently acquired by GE, developing and launching products in the field of stem cell banking and cellular therapies. Previously, David also held various senior management and engineering roles in the aerospace and high tech industry.

    David holds a Master degree in applied physics from the Louis Pasteur University and a Degree in Electro-Optical Engineering from the Jerusalem College of Technology. He has participated in Executive leadership and general management programs at the Harvard Business School and IMD.
     

    Gary McNamara

    Senior Delivery Manager, Aparito
    Gary McNamara

    Prior to this role Gary served 15 years in the British Army. His career started in Bomb Disposal before retraining to become an exercise rehabilitation instructor at the Defence Medical Rehabilitation Centre Headley Court. Gary has vast experience in seeing the stress that traveling too and from medical appointments can bring and the effect this can cause on a patients care pathway.

    George Cusatis

    Director, Regulatory Affairs, Merck
    George Cusatis

    George Cusatis is Director of Merck’s Device & Digital Health team, part of Global Regulatory Affairs & clinical Safety based in Upper Gwynedd, PA. In this role, he supports the Medical Device and Combination Product (MDCP) and digital health solutions business across Merck. George provides guidance and support for more than 40 products, including auto injectors, prefilled syringes, digital health software, and contraceptives.
    George has extensive experience with the Product Development Lifecycle, including product safety, regulatory submissions, quality assurance, and clinical affairs. Prior to joining Merck, he worked at Sanofi in Swiftwater, PA, as a Pharmacovigilance Scientist for postmarket and clinical vaccine and drug products, and as a Research Associate focused on clinical pharmaceutical and vaccine applications and discovery. George also has extensive experience as a research scientist, managing research and clinical teams at Johns Hopkins University and SUNY Upstate Medical University.
    George received a M.S. in Regulatory Affairs / Quality Assurance from Temple University in Philadelphia, a M.S. in Bioengineering from Syracuse University in New York, and a B.S. in Biology from Wilkes University in Wilkes Barre, PA. He is a member of RAPS to which he holds the RAC certification, ASQ, and DIA professional societies and holds ISO certifications in Quality Management Systems Requirements (ISO 9001), Information Security Management (ISO 27001), Service Management Systems (ISO 20000), and Medical Devices Quality Management Systems (ISO 13485). He is also an author on 14 peer-reviewed publications.
     

    Huanyu (Larry) Cheng

    Dorothy Quiggle Assistant Professor, Penn State University
    Huanyu (Larry) Cheng

    Dr. Huanyu “Larry” Cheng is an Assistant Professor of Engineering Science and Mechanics with courtesy appointments in the Department of Biomedical Engineering, Department of Mechanical Engineering, Department of Architectural Engineering, Department of Industrial and Manufacturing Engineering, and the Department of Materials Science and Engineering at Penn State University. His research group focuses on the design, fabrication, and application of stretchable and dissolvable multimodal sensors for biomedicine. Larry has co-authored more than 100 peer-reviewed publications with total citations >13,000 and an H-index of 45 according to Google Scholar. His work has been recognized through the reception of numerous awards, including the 2021 NIH Trailblazer Award, 2021 Scialog Fellow in Advancing BioImaging, 2021 Frontiers of Materials Award from the Minerals, Metals & Materials Society (TMS), First Place in the Ben Franklin TechCelerator Pitch in 2020, ACS Petroleum Research Fund New Investigator in 2018, Forbes 30 Under 30 Science category in 2017, elected member of the Global Young Academy for scientists under age 40 in 2016, among others. He also serves as the associate editor for 7 journals and reviewer for 175 international journals.

    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.
     

    James Mault

    Founder and CEO, BioIntelliSense, Inc.
    James Mault

    James Mault, MD, FACS, is the Founder and Chief Executive Officer of BioIntelliSense, a Data-as-a-Service (DaaS) platform company, delivering breakthrough medical-grade biosensor technology with unique clinical intelligence for scalable remote patient monitoring.

    Prior to BioIntelliSense, Dr. Mault served as Senior Vice President and Chief Medical Officer of Qualcomm Life for over five years, where his leadership responsibilities included Strategic Planning and Business Development, Mergers and Acquisitions, New Product Innovation, Clinical Program and Regulatory Oversight, Health Policy and Government Affairs, Global Spokesperson and Public Relations. Dr. Mault came to Qualcomm Life through its 2013 acquisition of HealthyCircles, a Care Coordination and Remote Patient Monitoring Platform Company founded and led by Dr. Mault in 2009. Prior to starting HealthyCircles, he was the Medical Director of the Health Solutions Group at Microsoft.

    Dr. Mault has more than 35 years of experience in senior executive positions in the Health IT and Medical Device industry as well as clinical medicine. He has founded five Health IT and medical device companies, raising over $150 million in working capital and leading these companies to develop novel devices and software technologies, FDA approvals, strategic partnerships with numerous Fortune 500 companies, culminating in M&A or IPO exit transactions. He is the named inventor of over 80 issued and pending patents for a variety of novel health IT and medical device innovations. He has been board-certified in both General Surgery and Cardiothoracic Surgery, having specialized in heart and lung transplantation, thoracic oncology and critical care. He has conducted academic medical research under grant awards from the National Institutes of Health, American Cancer Society, and others. He is the author of more than 60 scientific articles, chapters and books in the published medical literature.

    Dr. Mault received his B.S. in Biology and Medical Degree from the University of Michigan and conducted his General Surgery and Cardiothoracic Surgery residency training at Duke University Medical Center. Dr. Mault provides global thought-leadership on the future of technology and healthcare delivery, serving on numerous Boards and leadership positions including the Board of Directors of Bose Corporation, Executve Board of the Consumer Technology Association’s (CTA), Chairman of the American Telemedicine Association Clinical Trials Board and the Board of Trustees for the Astronaut Scholarship Foundation.
     

    Janeta Nikolovski

    Director, Innovation, Janssen R&D
    Janeta Nikolovski

    Janeta is an innovation leader with over 20 years of experience in Research & Product Development. She is Director of Innovation in the World Without Disease Accelerator at Janssen and is co-leading a large digital and device-based cardiovascular clinical trial. Her career has spanned the Pharmaceutical, Consumer, and Device sectors, having worked on strategy and product development, clinical study design and execution, behavioral science related to digital health and solution development, and external partnerships. Janet holds a Ph.D. in Biomedical Engineering and B.S. in Chemical Engineering from the University of Michigan.

    Jason Song

    Chief Technology Officer, SureMed Technologies, Inc.
    Jason Song

    Jason Song is Chief Technology Officer and cofounder of SureMed Technologies, Inc. that develops holistic novel technologies and products to meet the needs of patients, industry and society for easy deployment. Prior to SureMed Tech, he held various technical and leadership positions at Amgen, Eli Lilly, GE Healthcare, Motorola and Novo Nordisk in areas including injectable & inhaled drug delivery device development, fill and finish, packaging and assembly automation, biochips, and establishing new production sites. Jason's experience includes in US, Europe and Asian. Jason is a certified licensed Professional Engineer (P.E.) and holds BS & MS in Mechanical Engineering, MS in Automation MFG, and MBA.

    Natalie Wisniewski

    Principal, Medical Device Consultancy
    Natalie Wisniewski

    Dr. Wisniewski currently advises companies, academia and government organizations on technical developments and growth strategy for wearables, diagnostics, and home health. She cofounded Profusa, Inc. to develop tissue-integrating biosensors for mobile health monitoring. She has over 100 patents, papers and invited lectures n the field. Dr. Wisniewski was awarded the NIH Transformative Research Award for her work on mobile health monitoring and her company was named Global Entrepreneurial Company of the Year in 2019 by Frost and Sulliven. She holds a BS in chemical engineering from Purdue University and a PhD in biomedical engineering from Duke University.

    Owen McCarthy

    President, MedRhythms
    Owen McCarthy

    Owen McCarthy is the President and co-founder of MedRhythms, a digital therapeutics company that uses sensors, music, and software to build evidence-based, neurologic interventions to measure and improve walking. Owen is passionate about solving problems, seeking out challenges, and helping people.

    As the President and co-founder of MedRhythms, Owen has become a leader in the field of digital therapeutics. MedRhythms, a member of the Digital Therapeutics Alliance, is developing evidence-based, FDA-regulated devices to treat, manage, and diagnose neurologic injuries and diseases. Since founding MedRhythms in 2016, Owen has been invited to speak at digital therapeutics conferences and events across the country, including DTx West, DTx East, Neurotech Investing and Partnering Conference, Partners Connected Health Conference, and HLTH Evercore ISI Panel.
     

    Philip Wilson

    Marketing Director, Engineered Materials, Celanese
    Philip Wilson

    Philip Wilson is a Marketing Director with the medical polymers business of Celanese Engineered Materials. Phil has a PhD in Physics from the University of Texas at Austin and has worked for 20 years in a wide range of roles in the materials and chemical industry. He enjoys learning about new areas of technology to identify new opportunities for innovation.

    Rhoda Au

    Professor, Anatomy and Neurobiology and Neurology, Boston University School of Medicine
    Rhoda Au

    Rhoda Au is Professor of Anatomy & Neurobiology, Neurology and Epidemiology at Boston University Schools of Medicine and Public. She also serves as Director of Neuropsychology at the Framingham Heart Study, where she is using technologies to develop digital cognitive biomarkers as surrogate indices of fluid and imaging biomarkers. Her long-term research objective is to enable solutions that move the primary focus of health technologies from precision medicine to a broader emphasis on precision brain health.

    Sandra Komarzynski

    Data Scientist, Aparito
    Sandra Komarzynski

    Sandra is a Data Scientist at Aparito where she works primarily on developing analytical algorithms for physiological data (such as sleep, heart rate, physical activity) gathered from wearables to support the company’s product Atom5TM features. Her passion is the use of wearable digital devices to help patients gain greater control over decisions and actions affecting their health.
    Prior to Aparito, Sandra was a research fellow at Warwick Medical School within the Chronotherapy group where she was involved in cancer clinical studies which aimed to monitor cancer patients at home using wearable digital devices to identify causes of alteration in their circadian rhythms.
    Sandra has a scientific background in Medical and Health Engineering.
     

    Sanjiv Sharma

    Senior Lecturer in Medical Engineering, Swansea University
    Sanjiv Sharma

    Dr Sanjiv Sharma received his PhD on the development of analytical methods for determination of certain pharmaceuticals and their metabolites using miniaturised separation system in 2001. His PhD supervised by Dr Sunil Kumar Sanghi, was part of an Indo- European Community joint research project on miniaturised separation system in collaboration with University of Amsterdam. He then performed postdoctoral research in the areas of high throughput sequencing, clinical proteomics and miniaturised analytical systems in France and Germany from 2001-2004. In 2004, he was awarded a Chevening Technology Fellowship to work with Professor Andrew deMello on microfluidic microreaction systems in the Department of Chemistry at Imperial College London.

    On completion of his fellowship he joined the Institute of Biomedical Engineering, Imperial College London to work with Professor Tony Cass in the area of Bionanotechnology and Biosensors. Here he developed minimally invasive microneedles, from photolithographic fabrication to high throughput fabrication, taking these microneedles from the lab to the clinic. Sanjiv was involved in a NIHR (i4i) funded research project involving clinical studies in healthy volunteers and participants with T1D with renowned Endocrinologist Clinicians; Professor Desmond Johnston and Professor Nick Oliver. He has published over 50 research articles and has patents filed in Germany, UK and the United States.
     

    Veena Misra

    Distinguished Professor, Director , NSF Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies(ASSIST)
    Veena Misra

    Veena Misra is the Director of the National Science Foundation Nanosystems Engineering Research Center on Advanced Self-Powered of Integrated Sensors and Technologies (ASSIST). She is a Distinguished Professor of Electrical and Computer Engineering at North Carolina State University and a 2012 IEEE Fellow. She is also a distinguished lecturer for IEEE Sensors. She received the B.S., M.S., and Ph.D. degrees in electrical engineering from North Carolina State University, Raleigh. After working at the Advanced Products Research and Development Laboratories, Motorola Inc., Austin, TX she joined the faculty of North Carolina State University in 1998. She has authored or coauthored over 200 papers. Dr. Misra was the recipient of the 2001 National Science Foundation Presidential Early CAREER Award, the 2011 Alcoa Distinguished Engineering Research Award, and 2007 Outstanding Alumni Research Award and the 2016 R.J. Reynolds Award. She also served as the general chair of the 2012 IEEE International Electron Device Meeting.

    Vijaya Kolachalama

    Assistant Professor, Boston University School of Medicine
    Vijaya Kolachalama

    Vijaya Kolachalama is an Assistant Professor within the Department of Medicine, Boston University School of Medicine and the Department of Computer Science, Boston University, and a founding member of the Faculty of Computing & Data Sciences at Boston University. Research in his group is focused on developing advanced machine learning algorithms that have diagnostic relevance. His laboratory is funded by multiple awards from the National Institutes of Health, American Heart Association, private foundations and the pharmaceutical industry. His course entitled Machine Learning for Biomedical Applications attracts a diverse set of individuals with little to no background in computer science. Before joining Boston University, Dr. Kolachalama held appointments as a Postdoctoral Associate at MIT, as an ORISE Fellow at the US Food and Drug Administration, and as a Principal Member of Technical Staff at the Charles Stark Draper Laboratory. He was recently elected as a Fellow of the American Heart Association. He also won a few honors and awards including the Hariri Institute of Computing Junior Faculty Fellowship, Toffler Scholarship in Neuroscience from the Karen Toffler Charitable Trust, ORISE Fellowship at the US Food and Drug Administration, and a Young Researcher Fellowship at MIT.

    William G Hendren

    CEO, Qura Inc
    William G Hendren

    Dr. Hendren is an accomplished surgeon and healthcare business professional with extensive clinical, medical device, consulting, strategic and leadership experiences. He held leadership positions in cardiovascular surgery prior embarking on a focus on the business of healthcare that includes a multi-decade experience in commercialization of novel healthcare technologies. He is directing the development and commercialization efforts at Qura, Inc., a preclinical stage company with disruptive implantable sensor technology. He is a summa cum laude graduate of Dartmouth College, Harvard Medical School and Marshall Business School at the University of Southern California.

    Exhibitors

    Key Media Partners

    Supporting Media Partners

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

    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.
    HOTEL BOOKING FORM

    Preliminary Attendees 2021

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    Speaker Interview - Alex Gilbert, Huma

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    Speaker Interview - Natalie Wisniewski, Medical Device Consultancy

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    Speaker Interview - David Braun, Merck Group KgAa

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    Speaker Interview - Rhoda Au, Boston University School of Medicine

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    Speaker Interview - Janeta Nikolovski, Janssen R&D

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    Speaker Interview - Larry Cheng, Penn State University

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    Speaker Interview - Andreas Caduff, Digital Medicine Society

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    Workshop A

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    Workshop B

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    Speaker Bios 2021

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    Full Programme

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    Short Programme

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    Brochure 2021

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    Exhibitors


    Celanese

    Exhibitors
    https://healthcare.celanese.com/

    Celanese combines 40+ years of demonstrated success providing advanced, high-performance polymers and thermoplastics with in-house development services, GMP material supply and regulatory support for medical applications. Celanese’s customized solutions, including sustainable options, help our customers innovate in drug delivery, medical devices, orthopedics, advanced surgical instruments and connected devices applications.

    Media Partners


    ONdrugDelivery Magazine

    Key Media Partners
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    Pharma Journalist

    Key Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    American Pharmaceutical Review

    Key Media Partners
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Medical Design Briefs

    Key Media Partners
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

    Media Partners


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmavision

    Supporting Media Partners
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Pharmaceutical Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Pharmaceutical Outsourcing

    Supporting Media Partners
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Pharmiweb

    Supporting Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    ASD MEDIA

    Supporting Media Partners
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Contract Biotechnology

    Supporting Media Partners
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.

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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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