Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars. Biosimilar treatments offer similar benefits for the healthcare system as generic drugs, although they cannot be compared.

Writing for IPI Media World Arriello's Vanessa Fachada Oliveira on why so many Pharma companies are failing their regulatory audits

The coronavirus has had an enormous impact on European regulatory activity. To ease the strain and maintain vital supplies, the European Commission, European Medicines Agency, and Heads of Medicines Agencies published updated guidance in April, including new flexibility and simplified and accelerated authorisation procedures.

Summarising the 10 aspects of PV covered by the formal requirements, Vanessa Fachada Oliveira, Pharmacovigilance Manager & EU QPPV at Arriello, discusses where Companies are falling short and where they need to focus their attention to stay on the right side of inspectors.

Earlier this year the European Medicines Agency updated its guidelines, clarifying how to maintain supply of UK-registered products in Europe following December 31. Here, Cecilia Avram, Senior Regulatory Affairs Manager at Arriello, assesses what needs to change.

There has been much talk recently about the challenge of retaining talent in life sciences, particularly in relation to safety and regulatory disciplines, where younger professionals’ ambitions for a broad base of experience are jarring with companies’ needs to hold onto expertise they have invested in.

Local affiliates are arguably just as in need of outsourcing support as primary pharma locations. But drawing on such services should be frictionless, and involve close coordination with the vision and goals of HQ. Anna Lukyanova COO of Arriello, explores where biotech and pharma firms can go awry in their international service use, and offers tips on how to ease the transition for all.

Relieving local affiliates of heavy regulatory and/or pharmacovigilance workloads via a coordinated approach to outsourcing should be perfectly viable, but a frictionless global plan requires close coordination with HQ-level activities. Anna Lukyanova, COO of Arriello, offers advice on how to achieve a smooth transition...

Advanced digital tools are certain to play a pivotal role in the redesign of labour-intensive regulatory processes, but there is a danger that AI's potential contribution is being over-hyped to life sciences firms. Arriello's CEO Alan White warns that the key to ROI is in the application...

Never previously at the forefront of technology innovation, the life sciences industry now accepts that it needs to transform its agility, responsiveness and cost-efficiency, and that advanced digital tools are likely to form an important part of that strategy. Advanced digital tools are certain to play a pivotal role in the redesign of labour-intensive regulatory processes, but there is a danger that AI's potential contribution is being over-hyped. Arriello's CEO Alan White warns that the key to ROI is in the application...