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In this regard, the EMA published the directives on Assessment and Labelling of Medicinal Products in CNS disorders, which strengthens the EMA's approach to the assessment and labelling of medicinal products (including, in particular, in paediatric diseases) intended for use in the treatment of central nervous system (CNS) disorders. The use of endpoints in CNS disorders is expanding, and the collaboration of regulatory authorities and academic and industrial researchers is essential to the success of this process. Both academic research and industry have a role to play in this endeavour. Often, there is a need for industry to invest in experimental models and compounds for the identification of new therapeutic targets and to validate leads, and academic researchers to validate new techniques and tools. Extending the duration of clinical trials and facilitating the development of new models for the study of CNS disorders is essential to help reduce the costs of drug development.
Moving forward, the EMA is focusing on the promotion of innovation in the area of CNS disorders by stimulating scientific debates, creating opportunities to discuss about the current state of knowledge and the challenges and opportunities that need to be addressed in the field. The EMA is implementing a strategy to establish closer links with neuroscience researchers and other stakeholders. Also, the EMA will continue to increase collaboration with the pharmaceutical industry and with health authorities to address the unmet medical needs of patients with CNS disorders and to facilitate the development of new medicines for these conditions. The EMA will also focus on the use of biomarkers for the diagnosis and management of these disorders.
Furthermore, one of the main principles of the Commission's work is to make the regulatory process as efficient as possible and more transparent. This is why the agency has launched an open access policy: the idea is that any applicant for a new medicine (or health claim) should be able to access to the published data (or to the methodology used to collect the data) in a timely fashion. The aim is for the applicant to be able to directly request the data and to be able to decide for themselves whether and how to use the data. This approach is to be applied to all applicants (not only for health claims) and to all medicines and health products, including those for paediatric diseases.
The TFC is good, also if you do use the original board, or the clone board, because it is also a very good example on how to do a DIY project, pretty much all the components are easy to get, most of the time with only one or two vendors for each part, so you can easily change the layout and design to fit your needs.
One thing I have noticed from my own experience is that the original board has a small TFT screen, which is good for learning but not for doing, so if you are going to build a production version, just don't use the original TFT screen, just use a TFT screen of your choice, but do not forget to have an RS232 port for the back end, so you can test and debug the system. 827ec27edc