News from the industry
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.
An extension of the transition periods should certainly reduce the pressure on IVD manufacturers and the Notified Bodies involved.
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.
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.
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.
The emergence of a vaccine and an outlook on when a vaccine to protect against SARS-CoV-2 infection might be available.
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.