Medicon 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.
The 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.
When 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 therapeutic effect can be either a medicinal product/drug or a medical device, depending on its primary mechanism of action.
Developing this type of products are 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.
In 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.
If 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.
Date: 14th of September, 2022
Time: 14.30 – 18.00
Venue: Medicon Valley Alliance, Auditorium, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen
Host: Innokas Medical Ltd
PROGRAM:
| 14.30 – 15.00 | Registration, networking and light refreshments |
| 15.00 – 15.10 | Welcome Anette Steenberg, CEO, Medicon Valley Alliance Satu Päiväläinen, Specialist, Clinical affairs and IVD, Innokas Medical Ltd |
| 15.10 – 15.15 | IP and patents in combination products Pernille Winding Gojkovic, CEO, Høiberg European Patent Attorneys |
| 15.15 – 15.45 | Challenging development with combination products Satu Päiväläinen, Specialist, Clinical affairs and IVD, Innokas Medical Ltd |
| 15.45 – 16.05 | MDR compliance of substance based medical devices Rose-Marie Jenvert, Product Manager GARD applications SenzaGen AB |
| 16.05 – 16.20 | Short Break |
| 16.20 – 16.35 | BONESUPPORT- an orthobiologics company developing device-drug combination products that promote and protect bone healing Kristina Ingvar, EVP Quality Management & Regulatory Affairs & David Ball, European Medical Advisor, BONESUPPORT AB |
| 16.35 – 16.50 | Pharmia Oy: the future in substance based medical devices Anu Ahokas, R&D Specialist, Pharmia Oy |
| 16.50 – 17.10 | Concluding remarks: Building collaborations between organisations & Q&A to all speakers Satu Päiväläinen, Specialist, Clinical affairs and IVD, Innokas Medical Ltd |
| 17.10 – 18.00 | Networking |
Deadline for registration is 9th of September, 2022.
Medicon Valley Alliance Medtech Network gathers the region’s medtech industry to create new partnerships and business opportunities. Joining the network is free of charge for Medicon Valley Alliance members interested in gaining new insights, sharing experiences and networking with like-minded organisations. Non-member organisations and companies are welcome to attend one network event to evaluate membership.
| Host of the event | Sponsor |
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| MVA MedTech Network is managed by | In Collaboration with | |
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