Bianca Piachaud-Moustakis

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

A strategy on cyber resilience for health and social care organizations has been set out by the UK government.

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.

A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

The DGA seeks to increase trust in data sharing, strengthen mechanisms to make data more available, and overcome obstacles to the reuse of data, which are vital ingredients to the intersectoral use of health data.

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.