Navigating Combined Studies: The COMBINE Initiative and EMA's Role

Navigating Combined Studies: The COMBINE Initiative and EMA’s Role

Facilitating the development and authorisation of medicines used in combination with medical devices including companion diagnostics is a key priority for the EU regulatory network.

As innovative treatments increasingly integrate medicinal products with medical devices or in vitro diagnostics, navigating the different regulatory frameworks has become more challenging.

The COMBINE project aims to address the challenges sponsors face in navigating the regulatory interface between the regulations for clinical trials of medicinal products, medical devices, and in vitro diagnostics.

After an initial phase analysing the root causes of challenges that sponsors of combined studies encounter, the COMBINE initiative is switching gear. The next phase has started and will identify possible solutions so that Europe can remain an attractive place to perform combined studies.

The second phase of the project, as agreed in December 2024, will involve the development and implementation of the above-mentioned solutions. Key cross-sectorial projects are starting, and the collaborative effort will involve Member States’ competent authorities, the European Commission, medical research ethics committees, and stakeholders from both the medicinal product and medical device sectors.

With its centralised procedure, EMA oversees the authorisation of medicines used in combination with medical devices including companion diagnostics. As such, the Agency is actively involved in the COMBINE programme ultimately supporting the availability of innovative treatments for EU patients.

Morgane De Verdiere, European Medicines Agency, NL

My name is Morgane De Verdiere and I am the head of the Medical and Health Information service better known within the European Medicines Agency as the Medical Writers team.

I trained as a pharmacist in Paris and moved to the UK in early 2000 to work in Regulatory Affairs for a pharmaceutical company. I joined EMA in early 2006, working in the

Committee for Medicinal Products for Human Use (CHMP) secretariat for several years. After a stint in our Access to Document service, I moved to my current role in 2019 where amongst other things I oversee all medicines-related content that we publish in lay language.

At EMA, writing is a big part of our work and communicating clearly is a strength we cultivate and share internally. I am a strong believer that anyone can get better at writing clearly.