The MEB strongly invests in its Regulatory Science programme, resulting in a strong academic network and good cooperation with external parties. By building partnerships and investing in short term projects as well as longer term PhD trajectories, the MEB is continuously expanding and deepening its knowledge and expertise.
The MEB views Regulatory Science as essential to improving the regulatory efficiency and efficacy of medicines assessment in an age when social expectations about medicines regulation are not always realised.
The MEB's Regulatory Science Programme focusses on the 3 domains of the medicinal product life cycle:
- Research and innovation
- Regulation and decisionmaking
- Proper use and consumer safety
These domains correspond to the priorities of the MEB's Strategic Business Plan (SBP) for 2014-2018. Each domain houses a variety of programmes.
The MEB aims at broad cooperation in the field of regulatory science: in the Netherlands, within Europe, but also beyond. In each case, it is transparant about topics that support the high quality of the benefit-risk assessment of medicines. Through this cooperation, the MEB also strengthens the knowledge and competence between regulatory authorities, the academic world and pharmaceutical industry.
At the international level, the MEB is moving along with global developments around medicines and thinks along about new challenges that arise in this field. For instance, the MEB started a partnership with the medicines regulatory authority of Singapore (HSA Singapore) on research questions in the field of pharmacogenetics and proper use of medicines.
On the national level, together with the NVFG, the MEB took the lead in organising the first Regulatory Science Network Netherlands (RSNN) Workshop. With the theme 'Spotlight on Biomarkers: a different view on authorisation' the network set the tone for an open discussion between academica, regulators and pharmaceutical industry: where can successes be achieved that favour a variety of stakeholders? RSNN presented itself during the FIGON Dutch Medicines Days with a Regulatory Science programme and launched 2 newsletters.
The MEB is proud of the appointment of Marieke de Bruin as professor of Regulatory Science at the University of Copenhagen (Faculty of Health and Medical Sciences). Marieke de Bruin also became Director of the Copenhagen Centre for Regulatory Science (CORS). It offers new opportunities to cooperate with this institute in the coming years and share knowledge across Europe. The first step in this direction was already visible during the annual CORS Conference on Regulatory Science held in November 2016, where not only Bert Leufkens and Hans Hillege gave presentations, but where the EMA, the FDA, the PMDA, industry and patients' organisations gave their vision about developments within Regulatory Science.
Education and development
The Regulatory Science programme makes the MEB a recognised institute for regulatory education. The MEB has a sustainable partnership with various Dutch universities that house more than 10 PhD trajectories.
In total, 69 bachelors and masters students from different (academic and technical) universities have done internships at the MEB.
In the past few years, a considerable number of regulatory science projects have been submitted to the MEB Programme Office Science for approval and financing. A variety of subjects from these projects have been merged into programmes that form the core of the MEB's scientific agenda for 2016. These subjects relate to the optimisation of the medicines life cycle or to detailed research of the efficiency and efficacy of the regulatory system itself.
The MEB is systematically deepening its knowledge and expertise. For instance through 6 research programmes:
- 3V support
- Adaptive Pathways
- Safe (bio)Generics
- Optimised clinical trials
- Patient safety
- Fair Access
- MEB Science Day - Each year, the MEB organises a Science Day. This day provides an opportunity for academia, medical practice, the pharmaceutical field and the MEB to come together.
- FIGON Dutch Medicines Days – Since 2011. the MEB organises the Regulatory Science programme during the FIGON Dutch Medicines Days. The MEB chairs this day together with, among others, the Netherlands Association for Pharmaceutical Medicine (NVFG).
- Dutch Regulatory Science Network (RSnN) – The Regulatory Science Network, chaired by the MEB, was founded during the FIGON Dutch Medicines Days in October 2015.
- Regulatory Science Magazine – In 2013, the MEB launched an online Regulatory Science Magazine. From 2017, 4 editions of this magazine are published.
- PhD trajectories – The MEB website lists an overview of all the PhD trajectories and its results which the MEB Programme Office Science has financially supported.
Facts and figures
Since 2011, the Regulatory Science programme has resulted in the following:
- More than 280 scientific publications
- 27 dissertations, in close cooperation with the universities of Utrecht, Groningen and Rotterdam
- Support by the MEB of the almost completed research programme "Geneesmiddelenketen" (Medicines chain) of the RIVM
- 5 other scientific projects in cooperation with external parties