Spain will host the first international masters in manufacturing drugs in advanced therapies.

Andalusia, 2011-December Spain will host the first edition of the international masters in manufacturing drugs in advanced therapies that will take place from January to December of next year and whose objective will be to offer a theoretical and practical expertise to professionals who work in this area of research in health, specifically in the field of cell therapy, gene therapy and tissue engineering.

Organized by the Ministry of health, through the Andalusian initiative in advanced therapies along with the University of Granada, this master is aimed mainly at researchers and professionals who develop their activity or want to develop it in GMP laboratories for the manufacture of medicines cell, gene therapy and tissue engineering, and offers three different degrees of specialization: address technical, responsible production and responsible in quality control. In addition, the offer includes a quality assurance expert course.

The training programme has been defined by a team of experts including members of the Committee on therapy advanced from the European Medicines Agency, pioneers of the cell, gene therapy and tissue engineering, intellectual property experts and representatives of companies related to the sector. This programme provides a theoretical phase divided into eleven modules and other practice divided in two compulsory modules and optional two (depending on the chosen degree), as well as the holding of an international symposium to be held in Granada the month of June 2012.

From the theoretical point of view, the contents will be taught in a way online through a virtual platform and, among others, will be formed on relating to genetics and cell biology concepts linked to the production of medicines, the legislative framework in clinical trials, environmental controls and validations of facilities and equipmentas well as the pharmaceutical quality assurance system applied to advanced therapies.

For its part, the practical stage will have a period of two to four weeks depending on the type of specialization and will take place in the advanced multifunctional complex of simulation and technological innovation (CMAT) of Granada, which has a GMP lab that accurately recreates the actual conditions of manufacture of medicinal products for advanced therapies. During this phase, participating professionals learn in situ to manipulate and manufacture cell medicines.

Finally, students must do a tutorizado job, depending on the chosen specialization, which learn to make a technical report for the authorization of a GMP laboratory as well as a dossier of a medicinal product in research to be able to be used in a clinical trial.

Bet on therapies advanced health

The Andalusian initiative in advanced therapies is an initiative of the Ministry of health with the collaboration of the Ministry of economy, innovation and science. With his release in March, Andalusia has established mechanisms to encourage the development and implementation of advanced therapies so that, in a coordinated manner and with the support of universities, the pharmaceutical sector, private enterprises, researchers and patients ’ associations, take a qualitative leap and implementation research in health as a competitive element of the community.

The development of research in this field has allowed that, there are currently 17 clinical trials in cell therapy and tissue engineering at different stages of development within health Andalusian in areas such as Immunology, cardiology, Neurology, Gastroenterology, ophthalmology, hematology, vascular peripheral and gastroenterology.

These actions is intended to situate to Andalusia in a leading position in the field of translational biomedical research, a field of activity which aims to seek solutions to diseases which currently do not have them and that, at the same time, it forms part of the strategy of sustainable economyas investment in research works as an engine of economic and social development in Andalusia and their results, therefore accrues citizenship.