European Platform for Regulatory Science Research: Advancing research for improving medicine development and evaluation

As the platform celebrates its first anniversary, the RSNN spoke to Ralf Herold and Liese Barbier from the EMA, as well as Marjon Pasmooij from the Medicines Evaluation Board (CBG-MEB), who are leading on the Platform’s development and activities.

Connecting research and regulation across Europe

The European Platform for Regulatory Science Research was set up by the EMA and HMA with the aim to advance and accelerate research in regulatory science for public health impact. The platform offers a mechanism to strengthen the connection between academic research and regulators and regulatory needs. It aims to expand the community of researchers addressing critical scientific questions for the future of medicines regulation in their work.

The need for such a platform is clear. Advances in areas such as biology, genetics, data science, artificial intelligence, novel therapies, and new research methodologies are changing the healthcare landscape. In order to evaluate these innovations effectively, regulators and health professionals require robust scientific evidence and new methodological approaches. The European Platform for Regulatory Science Research seeks to facilitate the research needed to fill these gaps.

Turning regulatory challenges into research opportunities

At the heart of the platform are regulatory science research needs, which are scientific and methodological gaps and questions in regulatory science. These needs may relate to emerging technologies, novel data sources, clinical development approaches, or other areas where further evidence on their utility is required to benefit medicine development and regulatory decision-making.

The platform addresses these challenges by bringing together a growing community of academic and non-profit researchers and regulators. Multiple times a year, participants come together for online or hybrid meetings to discuss gaps in regulatory science, ongoing research, exchange ideas, and identify collaboration opportunities for making progress. Smaller working groups and workshops are established to further develop specific topics and deliver scientific and practical outputs.

Importantly, the platform is open to researchers from universities and other non-profit research organisations, including those who do not necessarily consider themselves to be regulatory scientists (researchers and regulators can register here: European Platform for Regulatory Science Research | European Medicines Agency (EMA)).

The platform is guided by a Steering Committee that includes representatives from academia and non-profit research organisations, industry and healthcare professionals and patient organisations, ensuring that a broad range of stakeholder perspectives is reflected in its activities. By bridging a diverse range of expertise, the initiative aims to stimulate innovative thinking and forge new connections between scientific research and regulatory applications.

The role of the RSNN

The Regulatory Science Network Netherlands (RSNN) was established in 2015 as a public-private partnership, bringing together stakeholders from across the Dutch medicines ecosystem. Representatives from academia, regulatory authorities, industry, and other organisations involved in medicines development and regulation are included in the network.

Through expert meetings, annual conferences and ongoing dialogue, the RSNN provides a platform for discussing current challenges in regulatory science and innovation. By facilitating the exchange of different perspectives, the network helps to identify barriers, share knowledge, and explore opportunities to enhance the regulatory landscape in the Netherlands. A close connection between the two initiatives is provided through Marjon Pasmooij, who co-chairs both the RSNN and the European Platform, helping to connect relevant developments, expertise and activities across the two networks.

Different approaches, shared ambitions

Although both initiatives operate within the field of regulatory science, their objectives and approaches are distinct.

The European Platform for Regulatory Science Research focuses on advancing research to generate solutions that can be implemented by medicine developers, regulators and other stakeholders. Its emphasis is on fostering research activities that helps to address well-defined needs in regulatory science. This includes identifying gaps in regulatory science, fostering collaboration between researchers and regulators, and supporting the development of new methodologies and approaches to generating evidence. The Platform has been established by EMA and HMA, but is open to stakeholders globally. 

The RSNN has a focus on facilitating  multi-stakeholder dialogue. It brings together regulators, industry representatives, academics, patient representatives, and other experts to discuss challenges and opportunities across the regulatory landscape. Through expert meetings, the network facilitates dialogue and encourages collaboration on issues affecting multiple stakeholders. Although RSNN mainly operates within the Dutch national context, its activities are not confined to the Netherlands and include engagement with international partners and initiatives.

Despite these differences in focus, both initiatives share an overarching goal of strengthening regulatory science to ensure medicines can be developed, evaluated, and made available to patients in a timely and effective manner. Both initiatives create valuable connections between science and regulation, encouraging collaboration across organisational boundaries.

Looking ahead

As the European Platform for Regulatory Science Research enters its second year, it aims to continue growing as a community for stimulating and leveraging regulatory science research. The platform contributes to a more future-proof regulatory system by fostering new collaborations, inform research and supporting the translation of its outputs into regulatory and R&D practice.

For the RSNN, this presents an opportunity to strengthen the connection between Dutch expertise and European developments. Building on the existing link between the two initiatives, they can create valuable synergies by combining their strengths: the European Platform can provide insight into emerging research needs across Europe, and the RSNN can contribute practical experience, expertise, and stakeholder perspectives from the Netherlands. By building these bridges, both networks can help to shape the future of regulatory science.