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DTSTART;TZID=Europe/London:20191001T093000
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SUMMARY:MPD Training Course: Strategic Implementation of European In Vitro Diagnostic Regulations
DESCRIPTION:Legal Manufacturers of In Vitro Diagnostic products need to be aware of the scope and implications of the new European In Vitro Diagnostics Regulations 2017/746. Organisations must be realistic and prepared. Not only for the impact of changes in the short-term\, but for the long-term implications to the development and maintenance of diagnostic products in the European Market. We only have until May 2022 to complete this compliance journey for some products\, so it is strategically critical that all impacted businesses have fully understood and assessed the impacts on their business. \nMedilink WM\, in conjunction with Acclaim Biomedical Consulting Ltd. is offering a one day workshop to focus on the implementation of European In Vitro Diagnostics Regulations. This will provide attendees with detailed understanding of strategic impacts and possible solutions which may be used to ensure compliance going forwards. \nWhy attend? \nBy attending this workshop you will: \nGain a thorough understanding of the changes and strategic consideration of the major impact areas of the revised regulations with indepth review of the major clauses of the regulation.\nHave the confidence and knowledge to review your own business and formulate plans to meet the transition to the IVDR based on this one day event\nGain insight and tools to plan and implement into your business strategy for continued access to the European market\, by the deadlines set in the new regulations\nLearn from other like minded business leaders\, on their challenges and strategies to achieve the necessary legal process.\nMeet the expert: \nManaging Director Richard Young 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. Richard 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. \nTarget audience \nDesigned for business leaders with executive responsibilities as well as Quality Assurance and Regulatory Professionals. \nThis course quickly identifies the areas of strategic impact\, possible costs and the time lines associated with the new EU In Vitro Diagnostic Device Regulations. \nBooking information: \nDelegate Fee: \nEarly bird fee – Register your place before Friday 23 August and receive a 10% discount \nMember fee: £180+VAT \nNon-Member fee: £215+VAT \nTo secure your place please contact Zoe Heather at zoeh@medilinkwm.co.uk or call 0121 452 5630 \nInvoices will be sent once booking has been confirmed by Medilink WM.
URL:https://staging.medilinkmidlands.com/event/mpd-training-course-strategic-implementation-of-european-in-vitro-diagnostic-regulations/
LOCATION:MTIC\, 4 Greenfield Crescent\, Edgbaston\, B15 3BE
CATEGORIES:Medilink Partner Event
ORGANIZER;CN="Zoe Heather":MAILTO:info@medilinkmidlands.com
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DTSTART;TZID=Europe/London:20191016T103000
DTEND;TZID=Europe/London:20191016T163000
DTSTAMP:20260423T215122
CREATED:20190715T095440Z
LAST-MODIFIED:20190715T095440Z
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SUMMARY:EU MDR Clinical Strategy & Evidence Requirements for CE Marking Workshop - 16 Oct\, London
DESCRIPTION:Wednesday 16th October 2019 \nHill Dickinson\, Broadgate Tower\, 20 Primrose Street\, London EC2A 2EW\, 10:30 – 16:00 \nSEHTA members fee – £250 + VAT per delegate  \nSEHTA non-members fee – £300 + VAT per delegate \nWhy attend \nClinical strategy\, evidence and evaluation are central to product approval and market access. \nThrough clinical data a company is able to ensure: \n  \n\nthat their medical device is able to obtain CE Marking and other regulatory approvals;\nthat the device performs clinically in both a safe and effective manner per the intended use and in the indicated patient population; and\nthat they are able to place it on the market supported by sufficient clinical evidence for user adoption and reimbursement.\n\n  \nIt is a requirement of the new EU Medical Device Regulation that a medical device company have a regulatory strategy and of the MDR and MEDDEV 2.7/1 rev 4 that the company have a clinical evaluation strategy. \nIn order to effectively market their device and generate sales\, organisations need to have considered well in advance the clinical elements for market access as failure to do so may put them back months\, through not understanding and obtaining appropriate data when initially gathering clinical evidence. \nNotified Bodies and regulatory authorities are placing greater emphasis on clinical evidence. Competent Authorities & regulators in other countries are also looking at clinical data and expecting up to date evidence. In addition\, purchasers of devices are increasing their requirements for clinical evidence that demonstrates good clinical outcomes and value (evidence-based medicine). The need for clinical evidence and evaluation is a core theme and needs to be captured to satisfy regulators\, notified bodies\, patients\, physicians\, procurement\, reimbursement agencies (e.g. NICE)\, etc. \nCompanies need to be prepared and have solutions in place to address this and their ongoing clinical requirements. Getting your clinical strategy wrong will delay approval and also market access. \nPlease note this is for Medical Device firms only – not Pharma or IVD \n  \nThis one-day workshop will give you: \n  \n\nAn overview of the new EU Medical Device CE Marking Process\nHelp you to maintain Access to the Market\nUnderstand the key areas of compliance required\nUnderstand the technical documentation that should be in place for each device\nGain a plan of action for implementation and CE Marking under the new legislation\n\n  \nTarget Market: C suite\, executives\, product owners\, medical officers\, regulatory and clinical specialists within a company that need to understand the overall clinical requirements for their medical devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful. \nTo view an agenda for this event\, click here \nTo register for this event\, click here
URL:https://staging.medilinkmidlands.com/event/eu-mdr-clinical-strategy-evidence-requirements-for-ce-marking-workshop-16-oct-london/
LOCATION:Hill Dickinson\, Broadgate Tower\, 20 Primrose Street\, London\, EC2A 2EW
CATEGORIES:Medilink Partner Event
ORGANIZER;CN="SEHTA":MAILTO:info@sehta.co.uk
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