As the falsified medicines directive is set to come into full force early next year, Christian Taylor, serialisation business consultant, Zetes, looks at the key challenges and practical questions relating to achieving compliance in more detail.
Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility.
As the General Data Protection Regulation (GDPR) take effect this month, Mark Stevens, managing director, Formpipe Life Science, looks at the key differences companies should be aware of and how they can attain compliance.
Biosimilar entry onto US market is slow despite implementation of the Biologics Price Competition and Innovation Act (BPCIA) by the Food and Drug Administration (FDA), according to data and analytics company, GlobalData.
As the deadline for compliance with the EU FMD gets nearer, Manfred Voglmaier, VP DACH (Germany, Austria, Switzerland) sales, TraceLink, looks at how master data management framework can help businesses meet the necessary requirements.
In this online exclusive, Dr Andrew Rut, CEO of MyMeds&Me, discusses the value of big data for the pharma industry and the conflict that arises between protecting personal data and effective drug development
The ‘Life Sciences Industrial Strategy: Who’s driving the bus?’ report has been published by the House of Lords Science and Technology Committee, recommending that the government should simplify its implementation arrangements.
A new study from the University of Eastern Finland, published in the European Journal of Clinical Pharmacology, has highlighted that there are differences in the availability of orphan medicines between different European countries.
There is rising tide of drug-resistant microbes that is thought of as one of the greatest threats to public health today, yet the pipeline of new antibiotics is dwindling. Here, Dr Peter Jackson, AMR Centre, discusses what action is needed
Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland.
With recent plans announced by the UK’s prime minister to remain part of the EMA, which would be favourable for many in the pharma industry, I will look at these developments as well as how they will impact industry and the reactions from leaders
As the guidelines for the negotiations of future relations between the EU and the UK are approved, allowing the progression of Brexit talks, pharma, biotech and manufacturing industry leaders give their opinions on the transition.
