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DTSTART;TZID=Europe/London:20220202T100000
DTEND;TZID=Europe/London:20220202T113000
DTSTAMP:20260413T112429
CREATED:20211013T074941Z
LAST-MODIFIED:20211013T074941Z
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SUMMARY:WEBINAR: Biocompatibility\, Practical Applications in the new MDR environment
DESCRIPTION:                                                        \n  \n  \n \n \n\n\n\n\n  \nThe next MedTech Regulatory Special Interest Group (SIG)\, hosted by regulatory affairs expert Richard Young\, from AcclaimBiomedical Consulting Ltd\, will provide a review of regulatory requirements and the application of biocompatibility in the new environment. \nRichard will be joined by Philip Clay\, Director and Principal Toxicologist\, Chorley Consulting and they will be covering: \n– Requirements of Annex 1 of the regulation 2017/745\n– A regulatory perspective on existing products\n– ISO 10993 the 2018 issue\n– Biological Evaluation Plans\n– Biological Evaluation reports\n– What Are the interpretations of the requirements being taken by notified bodies?\n– Application and assessment of Biocompatibility for existing products?\n– What are the typical implications for Biocompatibility Rationale and testing?\n– What are the practical constraints?\n– Limitations of existing testing? \nThis free-to-attend event is held as part of the ACTIS programme – a project part-funded by the European Regional Development Fund\, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses\, the value of which is £190\, but is delivered completely free of charge to participants. \nPlease note: whilst this event is held as part of the ACTIS programme\, attendance is not restricted to companies in the SEMLEP area and is open to all. \nDURATION: 1 hour and 30 minutes \nSpeaker Profiles:  \n \nRichard Young\, Managing Director\, AcclaimBiomedical Consulting Ltd\nRichard has an extensive background in regulatory affairs in addition to GMP (quality assurance)\, GLP (laboratory testing)\, and GCP (clinical). Spanning over two decades\, these core skill areas have been developed with experience in products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots\, through electromedical devices such as infusion systems and cardio vascular products. \nRichard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions. \nRichard’s skills and experience includes such areas as the development and implementation of effective quality management systems\, auditing to ISO and FDA QSIT standards\, and operating at national and international level through industry associations including Eucomed\, ABHI and ABHI Technical Policy Group. \n\nPhilip Clay\, Director and Principal Toxicologist\, Chorley Consulting\nPhilip is a UK and European registered toxicologist and specialises in safety assessment with over 30 years experience. He has published and presented widely in his expert field of genetic toxicology and also in the wider area of safety assessment. Chorley Consulting designs safety assessment programmes for medical devices and also provides toxicological advice for a range of product types. Philip is presently a BSI committee member for CH/194 (Biological evaluation of medical devices).\nChorley Consulting works with a number clients ranging from multinational manufacturers to single product start-ups. They have experience with assessing the biological safety of a wide range of devices including cosmetic surgery products\, surgical implants\, anaesthetic gas devices\, catheters and invasive patient monitoring systems as well consumer healthcare products ranging from Class 3 devices down to Class 1. Their biological safety assessments have formed part of technical file submissions to a number of notified bodies without comment as well as supporting clinical trial applications. They also have experience with medical device submissions to regulatory authorities around the world including US FDA and China NMPA. \n 
URL:https://staging.medilinkmidlands.com/event/webinar-an-update-on-current-changes-to-mdr-ivdr-role-of-the-person-responsible-prrc-2/
CATEGORIES:Project Event
ATTACH;FMTTYPE=image/png:https://staging.medilinkmidlands.com/wp-content/uploads/2022/04/ME_logo_blue_RGB-600x225-1.png
ORGANIZER;CN="Becky Sharpe":MAILTO:events@medilinkmidlands.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20220222T090000
DTEND;TZID=Europe/London:20220222T130000
DTSTAMP:20260413T112429
CREATED:20211013T074941Z
LAST-MODIFIED:20211013T074941Z
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SUMMARY:IN-PERSON EVENT: Thinking Differently for Business Growth
DESCRIPTION:                                                        \n  \n  \n \n \n\n\n\n\nThis event is part of the Leicestershire Innovation Festival\, organised by Medilink Midlands in partnership with Charnwood Campus. Charnwood Campus is a science\, technology and enterprise park based in Loughborough and is the first Life Sciences Opportunity Zone in the UK. \n \nInnovation is the cornerstone of success. Using innovation to adapt to changing markets and disruptive external factors not only helps ensure business continuity but also gives competitive advantage over competition.\nThis event will expose you to business leaders who were not afraid to do things differently\, who successfully embraced innovative solutions to streamline processes\, gain new customers\, enter new markets\, increase profitability during the process.\nConnect to our life science business cluster – entrepreneurs\, public and educational sector\, networking organisations and health and social care organisations to support the development of an innovation culture within your business. \nBy attending this event\, you will:\n– Learn from some of today’s leading disruptors\, market leaders\, and digital transformers in the life sciences\n– Discover how to create a culture of innovation that extends to all teams\, units\, and levels\n– Engage in highly interactive panel session that connect our speakers to your questions and input\n– Network\, collaborate\, and benchmark with your innovation peers \nProgramme \nSpeaker Profiles \nDelegate List \nThis free-to-attend event is held as part of the SoLSTICE programme – a project part-funded by the European Regional Development Fund\, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses\, the value of which is £508\, but is delivered completely free of charge to participants. \nPlease note: whilst this event is held as part of the SoLSTICE programme\, attendance is not restricted to companies in the Leicester/Leicestershire area and is open to all. \nHow to find the venue:\nCharnwood Campus is conveniently located on the outskirts of Loughborough\, for travel information please see their website here.  Please enter the site using the main entrance\, off Bakewell Road\, LE11 5RB.  Once on site\, if you are travelling by car complimentary car parking is available in car park E – see site map here.  The event is taking place in the Conference Centre\, which is in Building 21\, Innovation Centre. \nVenue and Delegate – COVID-19 Compliance: \n– All participants will be required to adhere to social distancing guidelines at all times\n– The rooms will be laid out with relevant spacing between tables/delegates\n– All rooms will be adequately ventilated with outside air\n– Additional cleaning will be carried out throughout the day\n– All rooms have hand sanitiser nearby\n– Social distancing measures will be in effect for all toilets\n– Face coverings are not essential\, however anyone who wishes to wear one can do so\n– It is recommended that all delegates and speakers complete a lateral flow test before attending this event
URL:https://staging.medilinkmidlands.com/event/thinking-differently/
LOCATION:Charnwood Campus\, Bakewell Road\, Loughborough\, LE11 5RB
CATEGORIES:Project Event
ATTACH;FMTTYPE=image/png:https://staging.medilinkmidlands.com/wp-content/uploads/2022/04/Charnwood-Campus.png
ORGANIZER;CN="Becky Sharpe":MAILTO:events@medilinkmidlands.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20220223T140000
DTEND;TZID=Europe/London:20220223T150000
DTSTAMP:20260413T112429
CREATED:20211013T074941Z
LAST-MODIFIED:20211013T074941Z
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SUMMARY:WEBINAR: Defining decentralised trials!
DESCRIPTION:                                                        \n  \n  \n \n \n\n\n\n\nJoin us for the next in the series of our Clinical Trial Special Interest Groups with Afortiori Development\, at this webinar “Defining decentralised trials! What actually defines a decentralised trial and how do they work in reality?”. \nThis webinar will focus on what it means to run a ‘decentralised trial’ in the real world! Hear from our panel of experts as they discuss key aspects of what it means to actually run a decentralised trial and how or if they can work for your study and product. Our speakers will discuss various tools and methodologies and then a discussion will follow that examines the importance of the right approach overall as the defining factor for study success. \nThis free-to-attend event is held as part of the SoLSTICE programme – a project part-funded by the European Regional Development Fund\, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses\, the value of which is £127\, but is delivered completely free of charge to participants. \nPlease note: whilst this event is held as part of the SoLSTICE programme\, attendance is not restricted to companies in the Leicester/Leicestershire area and is open to all. \nDURATION: 1 hour \nSpeaker Profiles:  \n\nChaired by: Dr Nicola Wall\, Chief Executive Officer\, Afortiori Development\nNicola co-founded Afortiori Development after a long career in clinical research within a variety of roles.  Nicola has extensive experience and a proven track record in global clinical trial management\, quality assurance and process management in the healthcare industry. Afortiori have built an impressive global team of clinical trial specialists\, clinicians and biostatisticians with experience in adult\, paediatric and neonatal clinical research\, and both primary and secondary healthcare settings. \n\nCheryl Bailey\, Senior Global Project Manager\, Afortiori Development\nCheryl has worked in numerous roles in the clinical research industry for over 11 years and is the Senior Global Clinical Project Leader at Afortiori\, responsible for the management and delivery of clinical trial activities within the company. She has gained an extensive range of key skills including project management\, ethics and regulatory\, monitoring\, financial management\, budgets\, protocol writing\, skills training\, quality management and laboratory experience. Cheryl has had a varied range of therapeutic experience:– mental health disorders\, diabetes\, Alzheimer’s and MCI\, renal disease\, sickle cell disease\, healthy population studies\, medical devices\, dermatitis and psoriasis. She has managed a wide range of studies across various phases of research both in NHS settings and in CRO/CRF settings\, allowing for the development of a sound knowledge base\, an understanding of necessary operational processes and the skills to drive clinical trials forward. \n\nTim Davies\, Business Development Manager\, The Medical Research Network\nWith over 25 years in research and development with large pharma and over 8 years decentralised clinical trial services for speciality\, orphan and biodiversity medicines especially in the provision of specialised decentralised Nursing. \n\nWessam Sonbol\, Co-Founder & CEO\, Delve Health\nA proven biopharmaceuticals and healthcare solutions strategist focusing on life science process improvement\, Wessam has nearly 20 years of experience in Phase I-IV\, IDE and 510(K) clinical research and healthcare business operations. He’s successfully managed a data\nmanagement organisation and worked with Fortune 500 companies such as Medtronic\, Abbott Vascular and J&J. Through breakthrough strategies\, Wessam helps achieve notable results in improving clinical trial outcomes.
URL:https://staging.medilinkmidlands.com/event/webinar-defining-decentralised-trials/
CATEGORIES:Project Event
ATTACH;FMTTYPE=image/jpeg:https://staging.medilinkmidlands.com/wp-content/uploads/2022/04/CB-Headshot-scaled.jpeg
ORGANIZER;CN="Becky Sharpe":MAILTO:events@medilinkmidlands.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20220224T100000
DTEND;TZID=Europe/London:20220224T110000
DTSTAMP:20260413T112429
CREATED:20220126T124856Z
LAST-MODIFIED:20220126T124856Z
UID:18822-1645696800-1645700400@staging.medilinkmidlands.com
SUMMARY:Webinar: Technical Innovation to support High Quality Care
DESCRIPTION:The COVID-19 pandemic has accelerated the pace at which we can adapt technology in health and care sectors\, working together flexibly in adopting new technology focused on users’ needs. Many health and care providers across the UK and globally have adopted technology innovation to enable faster treatment options and prevention services. Join De Montfort University’s Digital Health Team in partnership with Willows Heath and Medicspot\, for an insight into the latest developments in this area supporting the future of healthcare. \nThis webinar focuses on:\n• Experiences of health and care providers in adopting technology innovation\n• Innovation in action: working in partnership with health and care providers to meet the needs of communities\n• Factors driving change in technology innovation and the implications to health and the care sector \nThis event is part of Leicestershire Innovation Festival. For further details please click here \nThis free-to-attend event is held as part of the SoLSTICE programme – a project part-funded by the European Regional Development Fund\, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses\, the value of which is £127\, but is delivered completely free of charge to participants. \nPlease note: whilst this event is held as part of the SoLSTICE programme\, attendance is not restricted to companies in the Leicester/Leicestershire area and is open to all. \nDURATION: 1 hour \nSpeaker Profiles:  \n \nStuart Hilton\, Head of Commercial Partnerships\, DMU (Chair) \nStuart has over 30 years’ experience in developing commercial solutions to technical challenges that support project requirements across a range of different industries and business sectors both internationally and within the UK. Stuart is an experienced professional commercial manager with expertise in building connections between higher education and external organisations. \n  \n  \n  \n \nProfessor Bertha Ochieng\, Professor of Integrated Health and Social Care\, DMU \nBertha Ochieng is Professor of Integrated Health and Social Care\, Faculty of Health and Life Sciences\, De Montfort University. A key aspect of her research is in examining digital solutions that support development of integrated models of health and social care and community engagement. \n  \n  \n  \n \nDr Tariq Kapasi\, Medical Director –  Willows Health \nTariq is Co-Chair and Honorary Associate Professor at the Centre of Primary Care Research. He is passionate in developing governance processes to improve clinical outcomes for over 45\,000 patients. Tariq is forever appraising innovative methods by which they can help to engage\, educate\, and empower their patients.” \n  \n  \nSharon Donald\, Business Development Manager\, Medicspot \nAs a former A&E sister and hospital manager\, Sharon became a Business Development Manager in 1999 and is passionate about digital technology. For the last 14 years she has been working in digital health\, assisting customers to transition to a digital health service in areas including Liverpool\, Hull and Newham. \n  \n  \n 
URL:https://staging.medilinkmidlands.com/event/webinar-technical-innovation-to-support-high-quality-care/
CATEGORIES:Project Event
ATTACH;FMTTYPE=image/jpeg:https://staging.medilinkmidlands.com/wp-content/uploads/2022/04/Leicestershire-Innovation-Festival-email.jpg
ORGANIZER;CN="Jo Rudzki":MAILTO:info@medilinkem.com
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