Clinical evidence for IVD. Why you should use CLSI.
Discover the gold standard for in vitro diagnostics: How CLSI assessment protocols lead the way.
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News from the industry
Discover the gold standard for in vitro diagnostics: How CLSI assessment protocols lead the way.
The next-generation supply chain needs not only digital solutions, but also change management and the will to transform.
The audit trail is firmly anchored in regulatory requirements and guidelines, but the practical implementation is not always immediately comprehensible. This article shows how the requirements for the audit trail can be specified in the user requirements.
How CDMOs can forge value-based and strategic partnerships in the post-pandemic world.
Every company must protect itself against cyber attacks. Especially in the GMP environment, there are special challenges to overcome.
An extension of the transition periods should certainly reduce the pressure on IVD manufacturers and the Notified Bodies involved.
The laboratory of the future is digital. This article shows what the laboratory environment will look like in the future.
Is the next generation of therapeutic monoclonal antibodies tobacco plant-derived?
What future lies ahead for the generics and biosimilars industry? This article presents different futures that manufacturers could face.
Home office in the pharmaceutical industry will remain after the pandemic. This article looks at the regulations of the big players in the industry.
Data-driven surgery is the trend of the future in the pharmaceutical industry. But what steps are necessary for this?
Switzerland and the UK have recently been categorised as third countries by the EU. This affects trade relations between EU producers and producers from the UK and Switzerland.
The European Medicines Agency finds a solution that allows performing GMP and GDP inspections from remote.
The introduction of the COVID-19 vaccine is becoming the biggest challenge for chemical supply chains in history.
Under the title: "La Ola - was that the "perfect" wave?" our management consultant Dr. Ralf Hess gave an interview to the UNIversalis newspaper.
What the EU must do to make the pan-European health system crisis-proof in the future.
Dr Ralf Hess, Dominik M. Aumer, Moritz Haucke and Dr Simon Schulz publish articles on drug shortages and their causes in RAPS.
Research into a drug against SARS-CoV-2 is giving small molecules a renaissance.
How Corona exposes the failures of the European Health Service.
In addition to the development of new drugs against the coronavirus, tests are also being carried out at the same time to determine whether developed drugs, some of which have already been approved, can be repurposed in the fight against the virus.
Due to the SARS-CoV-2 pandemic, the EU has proposed to postpone the start of the new MDR by 1 year.
The emergence of a vaccine and an outlook on when a vaccine to protect against SARS-CoV-2 infection might be available.
No matter what you understand by digitalisation: Corona will significantly change the implementation of digitalisation
Transmission of 2019-nCoV infection through asymptomatic contact in Germany.
The "Corona crisis" calls for tough measures. These include so-called non-pharmaceutical interventions, which also include "social distancing".
Dr Ralf Hess, PhD, biologist and member of the Entourage Task Force, on travel and safety advice regarding the coronavirus.
Entourage Principal Project Consultant Dr Ralf Hess publishes article on the implementation of MDR & IVDR into national law. In Regulatory Focus. September 2019. Regulatory Affairs Professionals Society.
