Novartis Phase II substance as promising anti-tumor combination therapyMarch 2018The absolute number of new cases of cancer has almost doubled since the early 1970s in Germany. However, the mortality caused by cancer in Germany, as in most other wealthy countries, has declined significantly. This is mainly due to progress in therapy and probably also in early detection [1]. Every year, the global pharmaceutical industry […]
The new EU Counterfeiting Directive 2011/62 / EU — a major challenge for pharmaceutical companiesDecember 2017The new EU Counterfeiting Directive 2011/62 / EU — a major challenge for pharmaceutical companies The EU Counterfeiting Directive 2011/62 / EU was adopted in 2016 to minimize the risk of counterfeit prescription drugs in the legal supply chain. The change in the existing directive was prompted by the rapid increase in the number of […]
What are the challenges for companies through the new medical device regulation?July 2017On May 25th this year, the new medical device regulation came into force ("MDR" for "Medical Device Regulation"). This has significantly increased the workload for affected companies, as the new directives set high and changed requirements. There will inevitably be work peaks due to that.
Increasing need for external freelance support in the Life Sciences industryJune 2017Over time, companies in the Life Sciences industry, especially pharmaceutical and Medical Device companies, are confronted with new challenges more than ever. Here a new guideline, there a change in the corporate strategy or possibly the merger with a partner company and then, there is always the digitalization.
What has really changed after the introduction of Werkvertragsgesetz* in Germany?May 2017At the beginning of the year, we have already reported that the new law on the supply of temporary employees (personnel leasing) will come into force on April 1, 2017, and the BGB (German Civil Code) will be supplemented by a new paragraph (§611a). Today, after the introduction of the new law, we would like to give you a brief overview of what has actually changed for the self-employed part of the work force after the introduction.
Status Determination Procedure on Self-EmploymentFebruary 2017There is a new law on temporary work, which will come into effect from 1st April this year on. There are quite some changes coming along with it and people are worried that it will have a negative influence on their activities as a self-employed consultant and working on interim assignments.
Quasi self-employment in GermanyJanuary 2017Quasi self-employment is an important topic relevant for freelancers, all companies working with them and of course us, your freelance recruiter. The question is, whether a freelancer / consultant is really self-employed or actually works as a permanent employee – just without the respective taxes. The status of self-employment or not has implications on taxes, social security contributions and labour law. Which is why the government and politics care about this topic.
Challenges of the new EU Medical Device Regulation (MDR)December 20162017 will be the introduction year of new EU regulation on medical devices. After becoming applicable, companies will have three years to implement the new rules and guidelines it brings.
The applicable regulations so far have been „93/42/EWG Medical Device Directive (MDD)“ and „90/385/EWG Active Implantable Medical Devices (AIMD)“.
About Value-Based HealthcareNovember 2016When googling value-based health care definition you get about 6 million results. The oldest reference on the first page is from 2010, an article in the New England Journal of Medicine. But the topic is a bit older than that. The today influential network value-based health care center Europe has its beginnings in 2008 and was formed by healthcare and academic professionals. Its mission is to bring stakeholders together to have a common platform for discussing value-based health care (VBHC).
