Are you familiar with regulation (CE)? You know what to expect from the new MDR and IVDR 2017? Then they did your homework, do you think?

In Germany, 90 per cent of people are insured under statutory health insurance. The essential basis here is the German Social Code V (health insurance).

The SGB V is very financially and adminstrative-heavy. Concepts and topics such as evidence, studies, quality assurance, benefit assessment, additional benefit, patient use have taken a stronger influence in SGB V in the last few years. This applies in particular to the assessment of new active substances, new indicative areas of active substances, new methods of examination and treatment, improvement of quality of life, reduction of the duration of the illness or cost-benefit evaluations.

German institutes, such as the Joint Federal Committee (Gemeinsamer Bundesaussschuss) or the IQWIG, have been given SGB V. The Joint Federal Committee in particular has a decisive influence on the real supply and treatment situation. This can be done through decisions or guidelines. Comments may or may need to be sought.

Did you know that the top organization of medical technology manufacturers in the SGB V also played a role? These are then included when it comes to ensuring the quality of the service or the assessment of new methods of examination and Treatment (look after §§ 92, 135,137c, 137e SGB V).

We are constantly experiencing the fact that international medical technology manufacturers and LifeScience companies are not fully aware of the importance of SGB V for distribution in Germany.

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It was only a few weeks ago that IBM Watson (cognitive system) and Illumina (manufacturer of sequencing devices based on Next Generation Sequencing (NGS) technology) came out. In the context of the indication tumors an intensified co-operation is to arise. In addition to a very high sequencing capacity, NGS allows for the clonal sequencing of individual molecules, a higher diagnostic sensitivity by parallel sequencing of entire gene panels, simplified handling as well as the parallel and therefore more cost-effective processing of the samples. In other…Continue Reading “Next Generation Sequencing – Interdisciplinary cooperation MLL (Germany), IBM Watson (USA), Illumina (USA)”

Market overview of safe and reproducible purificationSample preparation in the laboratory with molecular biology

 

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The research focus on pharmacogenomics and individualized medicine at the german BfArM is to investigate the extent to which the genetic predisposition contributes to how a specific patient responds to a drug. There are genetic influences on the breakdown of drugs in the body, metabolism (metabolism).Ultrasound metabolizers are significantly faster in drug use than most people. As a result, this group increases the risk that certain side effects occur or the therapeutic effect does not occur. In the case of poor metabolizers, which degrade the…Continue Reading “Pharmacogenomic diagnostics is part of the German innovation fund 2017”