Seminar “Review of the key stages of market deployment of medical products and software: from testing and registration to the promotion and participate in public purchases"
On the 8ht of November 2018, in Skolkovo Technopark took place seminar ‘’Review of the key stages of market deployment of medical products and software: from testing and registration to the promotion and participate in public purchases.”
The organizer of the event was MEDITEX NTC, LLC that was common use center.
The main issues of the seminar: How to enter the market with a new medical product, where to start, how to become competitive in the Russian and international markets.
The representatives of Skolkovo Biomedical Cluster, managers of MEDITEX NTC, medical software developers and experts in the field of clinical trial took part in the meeting.
Yuliya Gulenkova, COO of Skolkovo Biomedical Cluster, opened the seminar, made welcoming remarks and presented a review of the key stages of market deployment of medical products and software.
Andrey Vilenskiy, MEDITEX NTC Director-General and the main seminar moderator, explained the term “medical product”, according to Federal Law No. 323 “On the Bases for the Protection of the Health of Citizens in the Russian Federation” described what was included in it, spoke of the regulatory strategy to market deployment of medical products and relevant regulatory authorities that influence the entire life cycle of a medical product.
Vera Berezina, Clinical Research Center, Ltd Director-General, made an interesting presentation about types of clinical trials, the main principles and estimation clinical algorithm, work with literature sources and also choice, evaluation and control over the work of contractors.
Alexander Gusev, Complex Medical Information Systems, Ltd specialist, reported on the problem and barriers in the registration of medical software in ROSZDRAVNADZOR, the administrative and criminal penalties for non-registered medical software trafficking and also he shared the US and Europe experience with participants.
The representatives of Innovative center "ISKRA" took an active part in the meeting, held discussions with experts from the manufacturing companies and have shaped the development strategy of the company's projects take into account recent developments in the legislation and regulatory strategy.
Yuliya Shcheglova, project manager of Skolkovo Biomedical Cluster, concluded the seminar with remarks on “The Skolkovo Fund's support in market deployment of medical products and software”. Yuliya spoke on the types of Skolkovo Foundation assistance to promote projects and common use center reimbursement with grants and microgrants.
The seminar turned out to be unique in terms of the volume and value of information. It is such meetings that enable today's business in market deployment of medical products and software. Throughout the seminar its online translation was provided.