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News from the industry
Flexible QP expertise exactly when you need it. Batch releases, compliance & project support - tailor-made and ready to use.
The modern supply chain is facing immense challenges such as increasing customer demands, disruptive technologies and global uncertainty. Companies need to transform their supply chains into robust, data-driven networks in order to remain competitive.
The Covid-19 pandemic has not only exposed weaknesses in the pharmaceutical industry's global supply chain, but has also initiated a transformation. Contract Development and Manufacturing Organizations (CDMOs) in particular are faced with the task of redefining their role and creating long-term value through strategic partnerships, digitalization and sustainable innovation.
The generics and biosimilars industry is undergoing fundamental change. Technological innovations, increasing regulatory requirements and the influence of platform companies such as Amazon Pharmacy are creating new challenges and opportunities. This article shows how the industry could develop by 2030+ and which scenarios will shape manufacturers in the future.
Digitalization is transforming the pharmaceutical industry with technologies such as AI, automation and big data. It increases efficiency and transparency and creates competitive advantages.
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.
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?
Home office in the pharmaceutical industry will remain after the pandemic. This article looks at the regulations of the big players in the industry.
The pharmaceutical industry is at a turning point. Big data, digital twins and intelligent automation are enabling companies to optimize their processes, reduce costs and respond more agilely to market requirements. This article shows how managers are successfully shaping the digital transformation and which technologies will shape the industry by 2025.
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.
Our management consultant Dr. Ralf Hess gave an interview to the UNIversalis newspaper under the title: "La Ola - was that the "perfect" wave?
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.
