IGES International Clients

Single-market regulation and innovation in europe medical devices industry

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Back Market Access Successful market access requires a clearly defined but flexible market access strategy. Our strategic market access planning therefore takes into account all available insights for a product, the competitive landscape and various stakeholder perspectives.

Our excellent system know-how enables us to make reliable forecasts and provide convincing solutions.

single-market regulation and innovation in europe medical devices industry

We deliver assessment of inpatient and ambulatory sector potentials based on the specific requirements of the individual markets and we analyze the competition and regulation within the EU.

This includes complex and Europe-wide cost-effectiveness models.

IGES International Clients

Depending on the needs of our clients, we develop budget impact or cost-of-illness models aimed at specific stakeholders that always retain their relevance to clinical practice. Our experience lies primarily in the European lead markets as well as Austria and Switzerland.

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In addition to developing submissions, our HTA teams have experience in producing high-quality early HTA feasibility studies, European core value dossiers, and health economic publications.

Back Strategic HTA Consultation In addition to the classical HTA business, we offer our customers advice on far-reaching strategic HTA challenges, such as off-label comparisons, lack of randomized study evidence and insufficient data.

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We also advise you on answering competitive assessments, conduct strategic single-market regulation and innovation in europe medical devices industry of previous submissions and obtain expert advice from clinical and commercial advisory boards or expert interviews. This results in an excellent knowledge of the market, its players and developments.

As a competent partner, CSG supports clients in the successful implementation of the following studies: Phase II to IV trials, non-commercial trials and non-interventional studies of pharmaceuticals and medical devices.

Back Evidence Development Our dedicated evidence development team has extensive experience in a variety of literature search methods for various purposes. Our expertise ranges from systematic reviews to pragmatic reviews to gap analyses of competitors. We are proud that we are able to adhere to the most rigorous systematic review methods and conduct our clinical, quality of life and economic reviews for HTA submissions in accordance with the submission template requirements.

New Reimbursement Models for Gene Therapies Gain Increasing Importance New contract models for the reimbursement of highly innovative pharmaceuticals are becoming increasingly significant for experts all over the world.

Single-market regulation and innovation in europe medical devices industry

They predominantly involve success-driven payment models for gene and cell therapies. European health systems offer some particularly interesting opportunities for implementing success-driven reimbursement models, as was concluded at an IGES Group event held at the Bio Conventionthe largest global convention for the life sciences and biotech sector. Some of these therapies offer the chances of a cure for many conditions which were previously untreatable.

Others have the potential to make symptomatic treatment, often administered over the course of decades, redundant. According to an IGES prognosis, approximately 40 pharmaceutical preparations are at a pre-market launch stage. Challenge for national healthcare systems worldwide Simultaneously, these innovative therapies come at a high cost for national health systems, either because the numbers single-market regulation and innovation in europe medical devices industry patients requiring targeted treatment approaches are low or because treatment solely involves one-time administrations with no opportunity to distribute the development costs over a longer treatment periods.

Against this background, new payment models have been developed, which formed central focus of the podium discussion held at the BIO convention.

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The first of such pay-for-outcome-models have already been implemented in the USA and Europe. The panel focused on different reimbursement models such as rate payments, refund models and adaptive pricing models.

Particularly intensive discussions were held on the subject of conflicting priorities with regard to single-market regulation and innovation in europe medical devices industry national evidence collection requirements and harmonization of registration requirements for both the approval process and national reimbursement systems.

New reimbursement models are to ensure patient access to innovations Another particular focus of the discussion was on the subject of integrating data collected during the application of new therapies into existing HTA systems on the one hand and innovative reimbursement models on the other.

Healthcare Industries

The discussions made clear that both the payers and the industry are highly interested in warranting comprehensive patient access to novel therapies via innovative payment models as early as possible. According to Berkemeier, the US prices for these drugs were on average 80 percent above the international average and would result in 47 percent higher drug expenditure for the state-run Medicare system.

According to Berkemeier, implementing such a reference pricing system would greatly impact US drug reimbursement and also have considerable repercussions in Europe. Its implementation does not require approval by the US Congress. Focus on European pricing single-market regulation and innovation in europe medical devices industry reimbursement systems "If a reference pricing system is introduced in the USA, a correct market introduction strategy becomes critical for Europe so as to prevent, or at least minimize, negative effects on patient access, particularly in Europe" Fabian Berkemeier ascertained.

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  • The Eudamed is a database that incorporates information on economic operators, devices, UDI, certificates, clinical studies and performance studies, vigilance data and market surveillance into a single, globally assessible platform.
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Highly innovative global biotech companies with a strong focus on the US market are consequently also focussing more strongly on pricing and reimbursement strategies in Europe. The Group was part of exhibition cluster for capital city region of Berlin-Brandenburg. The Bio Convention took place from 3 to 6 Single-market regulation and innovation in europe medical devices industry approximately 1, exhibitors and over 15, visitors.

Since its first publication inthe Atlas annually reports on market developments, innovations, costs and the medical value of pharmaceuticals.

The analyses of the Atlas are a widely accepted fundament for prognosis as well as economic and political evaluation of drug expenses for government, statutory health insurance and industry.

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It is, essentially, a mathematical model which splits the annual cost increases into ten components in order to better understand them. In addition to a consumption-based quantity and price component, the atlas also contains eight structural components. Two of which are based on the annual changes in the assortment of pharmaceutical products due to innovations: The so-called "therapeutic approach" component indicates how much the substitution of a substance with a single-market regulation and innovation in europe medical devices industry similar effect but containing different active substances and based on a different active principle would cost substituting, e.

The "analog" component, in contrast, estimates differences in expenditures which arise due to switching from one medication to another, chemically similar medication.

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The latter may single-market regulation and innovation in europe medical devices industry be seen as financial evidence of expensive "pseudo innovations" or "me-too" drugs in use.

Together, these five countries make up over two thirds of the entire pharmaceuticals market in the EU with a market share of billion euros. It aims to make more comprehensible the specific and very different regulatory procedures for pricing and reimbursement in the five different countries.

For all EU countries, general approval processes for new drugs, including the required efficacy and safety assessments, are usually conducted through the European Medicines Agency EMA via a centralized EU procedure. However, applications for decentralized procedures in individual countries are also possible. Benefit assessment procedures and health technology assessments HTA vary greatly between the different countries.

Requests for consultations must be made in the form of a letter of intent. Alongside the EU Guide, two additional newly edited publications describe in detail the life sciences market in Germany alone.

They are especially directed at developers from abroad. Contact person: Ms Agata Daroszewska Tel.: The Southampton based consultancy provides comprehensive health economic and strategic services for international medical device manufacturers focused on launching innovative products to both the U.

New business models and market participants

With this majority acquisition, the IGES Group continues its European expansion, servicing the growing global medical devices market in which Germany and the U. Furthermore it has traditionally been seen as a European beach head for global companies to launch into Europe.

single-market regulation and innovation in europe medical devices industry

The aim of this acquisition is to strengthen these connections and make them usable for all our international clients. Branagan-Harris said: The deal strengthens our respective market positions and build the potential for our growth in the European markets.

IGES Event: New Reimbursement Models for Gene Therapies Gain Increasing Importance

For more information: This guide explains the German market for medical devices in a European context, explains how to obtain the European CE mark and describes the German healthcare system and the general concept of reimbursement of medical devices in the German inpatient and outpatient sector. The fourth edition features the latest developments of the German medical device market and regulations.

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When released first inthe brochure became quickly a useful tool for many innovative medical device manufacturers around the world with an interest in getting access to the German market.

As regulations and market data change quickly, AiM decided to up-date the guide every year.