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DTSTART;TZID=Europe/Stockholm:20220914T143000
DTEND;TZID=Europe/Stockholm:20220914T180000
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UID:29741-1663165800-1663178400@senzagen.com
SUMMARY:2022 MVA MedTech Network meeting
DESCRIPTION:Drug device combination products and substance-based medical devices\nSep 14 | Copenhagen\, Denmark\nMedicon Valley Alliance\, together with member company Innokas Medical\, have the pleasure to invite you to the Medicon Valley Alliance MedTech Network meeting\, on the 14th of September\, focusing on drug-device combination products and substance-based medical devices. \n\nSign up here\n\nThe market for drug-device combination products is growing and it is anticipated that up to one in three medical products in development is a combination of a drug/substance and a MedTech product. Drivers for the growth in combination products is the rise of patients suffering from chronic diseases such as diabetes\, cancer\, and respiratory problems as well as growth in the home-based health care market and technological advancements. \nWhen searching for the correct regulatory approval in the EU the primary mode of action (PMOA) will define the regulatory path for your products. For example\, if the action of your medicinal substance is ancillary\, then your product is regulated as a medical device under MDR\, on the other hand\, if the product is mainly of the medicinal substance the product will be regulated as a medicinal product.  A substance with a therapeutic effect can be either a medicinal product/drug or a medical device\, depending on its primary mechanism of action. \nDeveloping this type of products is associated with a high level of complexity. For combination products\, you need to navigate two of the most intensely regulated pathways in one go: for pharmaceuticals and medical devices. The re-classification of substance-based medical devices according to MDR means a more extensive risk assessment involving scientific evidence of PMOA. \nIn this MVA MedTech Network meeting\, we would like to invite you to hear from experts in the area of developing drug-device combination products and substance-based medical devices as well as hearing from companies sharing their experiences\, challenges and solutions.\nIf you are interested in sharing your company’s approach and experiences with drug-device combination products and/or substance-based medical devices and to speak at the meeting on the 14th of September\, please reach out to Sofia Norås\, sn@mva.org. \nAgenda\n14.30 – 15.00  Registration\, networking and light refreshments\n15.00 – 15.10  Welcome\, Anette Steenberg\, CEO\, Medicon Valley Alliance; Satu Päiväläinen\, Specialist\, Clinical affairs and IVD\, Innokas Medical\n15.10 – 15.15  IP and patents in combination products\, Pernille Winding Gojkovic\, CEO\, Høiberg European Patent Attorneys\n15.15 – 15.45  Challenging development with combination products\, Satu Päiväläinen\, Specialist\, Clinical affairs and IVD\, Innokas Medical\n15.45 – 16.05  Substance-based medical devices\, Rose-Marie Jenvert\, Product Manager GARD applications SenzaGen\n16.05 – 16.40  Company cases TBC\n16.40 – 17.00  Concluding remarks: Building collaborations between organisations & Q&A to all speakers\, Satu Päiväläinen\, Specialist\, Clinical affairs and IVD\, Innokas Medical\n17.00 – 18.00  Networking
URL:https://senzagen.com/event/2022-mva-medtech-network-meeting/
LOCATION:Medicon Valley Alliance\, Auditorium\, Arne Jacobsens Alle 15 \, 2300 Ørestad City\, Copenhagen\, Denmark
CATEGORIES:Conference
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DTSTART;VALUE=DATE:20220921
DTEND;VALUE=DATE:20220922
DTSTAMP:20220916T085253Z
CREATED:20220427T123124Z
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UID:29390-1663718400-1663804799@senzagen.com
SUMMARY:2022 ICT/IUTOX/EUROTOX
DESCRIPTION:2022 International Congress of Toxicology – “Uniting in Toxicology”\n\nDiscussions at this year’s ICT\nNew opportunities for skin sensitization testing with GARDskin OECD TG 442E\n\nCome visit us at our booth and join our industry symposium to learn how the high performance and broad applicability of the GARDskin method bring new opportunities to the field of in vitro skin sensitization testing. We will provide user cases to show how GARD can be used to fill data gaps during regulatory testing and R&D. \n\nIndustry symposium\nNew GARD data on “difficult-to-test” substances and potency assessment\n\nSep 20\, 12:00-13:00 CEST @Room 0.09 Athens\n \nREGISTER HERE TO SECURE YOUR SEAT\n(click the link or fill out the form below)\nFill out my online form.\n \n\nHighlights at our booth #34\nDiscover our expanded in vitro toxicity testing services\n\nDo you have “difficult-to-test” samples or are you looking for quantitative skin sensitizing potency information? Come discuss your testing needs with us and learn more about GARD and our expanded in vitro toxicity testing services for cosmetics\, chemicals and medical devices. \nFIND OUT ABOUT OUR SERVICES AND EXPERTISE
URL:https://senzagen.com/event/2022-ict-iutox-eurotox/
LOCATION:Maastricht
CATEGORIES:Conference
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