Rare diseases affect only or as much as 6 – 8% of humanity. They are very rare, but they do exist and people suffer from them. In Poland disease is defined as a rare when for 10,000 people up to 5 of them become ill. If you take into account the number of people...
In 1923, Sir Frederick Grant Banting, a Canadian scholar at the age of 32, was awarded the Nobel Prize for the discovery of insulin, a hormone produced by beta-cells of the pancreas. Diabetes is a metabolic disease during which insulin production is disturbed, the small amount of which causes hyperglycemia in the body because...
We celebrate the World Day for the Prevention of Obesity 24th October and that is why we would like to draw your attention to the overweight problem in Poland and its relationship to cancer. Statistics In recent years, the number of people struggling with overweight and obesity increased significantly – in Poland this problem...
The Regulation 536/2014 will repeal Directive 2001/20/WE and comes into application in 2019. The change of law will require adjustments in documentation evaluation timelines and all procedures connected with this process. The aim Regulations’ goal is to unify and harmonise the assessment and supervision processes for clinical trials throughout the European Union, via an EU...
CRSN is a network of clinical research sites and is one of the largest alliances of clinical trial research sites in Poland. We specialize in coordinating clinical trials on sites level what gets our Partners access to a large sites network. We offer a convenient solutions which makes clinical trials management more efficient thanks to...
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t involved in the production or marketing of medicines and those that are not responsible for the organization and management of research contracts, eg. universities, health care settings, patient or researchers organizations, or the investigator himself. The sponsorship aspect of non-commercial trial is defined by the Pharmaceutical Law (Article 37a): “If the owner of the...
We’re trying to change our lives by changing our eating style, by changing our lifestyles, going to the gym, smiling more. Does it help, all those efforts? Will it change our bodies, our genes, genomes of our children? Epigenetic All those efforts cause epigenetic changes, which means the sequence of our DNA stays the...
EMA, FDA and PMDA held a second tripartite meeting in Vienna on 26-27 April 2017. The main topic were regulatory approaches for the evaluation of antiobacterial agents and differences of data requirements. It is important to unify requirements in clinical trials industry in order to provide similar requirements for pharmaceutical companies conducting those trials...
