The Regulatory Science Network Netherlands (RSNN) will organize its annual workshop this year on Tuesday 23 November (Jaarbeurs, Utrecht, The Netherlands). This meeting will focus on the ‘upstream’ coordinated, structured and harmonized regulatory framework established at a European level (high level of convergence) transferring ‘downstream’ to individual member states with each their own interpretations (lower level of convergence). In this RSNN workshop we want to explore if and how these differences in downstream interpretation between nations affect accessibility of medicines and treatments for patients. Are the existing differences undesirable and/or inevitable? What is the view of the stakeholders involved (regulator, academia, industry, and patients) regarding international differences in interpretation of upstream harmonised systems? Specific present day regulatory topics will be presented to elaborate upon this topic, including (inter)national differences in vaccination strategies, ATMP treatment under the Hospital Exemption, and health technology assessment.
One of the main goals of regulatory science is to inform decision-making with the best evidence, and contribute to a regulatory system that is responsive to societal needs, ensures patient access to efficacious and safe medicines, adapts to scientific innovation and conducive to a fertile R&D ecosystem. In this RSNN workshop we want to explore the key regulatory science questions in the coming years, and especially address how collaborative research can be of most value for regulators, patients, companies, HTA bodies, academia and other stakeholders. Discussions with the audience, representing various backgrounds are a critical element in this respect.