In 2016, the MEB presented its ambitions in Europe with regard to regulatory science. For example, the Netherlands organised a meeting for the prestigious IMI project Adapt-Smart, led by MEB Chairman Bert Leufkens. The aim of this project is to develop strategies to bring innovative medicines to market more quickly. The project is organised by Lygature Escher. This independent research platform with a pan-European focus aims to bring about a more efficient and effective regulatory system for medicine authorisation.
The 5th edition of the MEB Science Day had an international setting for the first time. ‘Pharmacogenetics, on the way to Regulation and Clinical Application’ was an ideal theme for this. In a globalising world, for proper use of medicines it is becoming increasingly important to focus on the individual patient. Singapore’s Health Sciences Authority (HSA) presented examples of success, such as the screening of the Asian population for a genetic predisposition to the development of the serious adverse reaction Stevens-Johnson Syndrome when using the anti-epileptic drug valproate (Depakine). Thanks to the screening, there has been a considerable reduction in this adverse reaction in Singapore. During the MEB Science Day, new steps were taken in the development of meaningful cooperation between the MEB and HSA Singapore.
The MEB’s regulatory science programme includes attention for ethical and human rights issues related to the authorisation and use of medicines. In this way, the MEB aims to spark a wide-ranging debate on medicine development.
At the end of September, the MEB presented its European regulatory science programme during TOPRA Amsterdam. Speakers representing medicines regulatory authorities from the Netherlands (MEB), Germany (PEI) and Denmark (CORS) participated in this meeting for professionals from medicines regulatory authorities in Europe. The 3V project was highlighted as an example of the knowledge that can be gained from regulatory science. The 3R approach (known as the 3V approach in Dutch) is used to limit animal testing. This is done by means of the replacement, reduction and refinement (increasing the well-being) of laboratory animals.
Together with the Dutch Society of Pharmaceutical Medicine (NVFG) the MEB took the lead in organising the first workshop of the Regulatory Science Network Netherlands (RSNN). With the theme ‘Spotlight on Biomarkers: a different view on authorisation’, the network set the tone for an open discussion between academics, regulators and the pharmaceutical industry. The key question was: 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 for the day and launched 2 newsletters.
The MEB is proud to look back on the appointment of Marieke De Bruin as Professor of Regulatory Science at the University of Copenhagen (Faculty of Health and Medical Sciences). She also became the Director of the Copenhagen Centre for Regulatory Science (CORS). De Bruin was previously a consultant in the MEB's Pharmacovigilance Unit. This offers new opportunities to cooperate with this institute 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. Besides Bert Leufkens and Hans Hillege (CHMP member representing the Netherlands), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the industry and patient organisations presented their views on developments in Regulatory Science.
- Appendix D: MEB participation in committees and working groups in 2016
- Appendix E: List of doctorates and scientific publications in 2016
Scientific publications in peer-reviewed magazines
Number of doctorates completed annually
|Number of doctorates completed annually|
Number of doctorates completed annually within the framework of the Escher project: 4 (in 2012).