Aniridia is a devastating ocular disease requiring intensive eye care, social and community support from birth and throughout an individual’s lifetime.

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Aniridia-Net and Aniridia Europe are happy to announce this new webinar on the regulatory framework of orphan medicional products, presented by Dr. Gloria M. Palomo (Non-Clinical Assessor for the Spanish Medicines Agency), and hosted by Dolores Pérez (Clinical documentation & Advanced Therapy Unit Head, Sermes CRO).

Save the date for this meeting with science and aniridia! Friday 20th May 2022 at 13:00 CEST, live streamed in Aniridia Europe’s YouTube Channel

There are currently more than 30 million people in the European Union affected by one of the more than 6,000 rare diseases identified to date. There are very few medicines intended for the treatment of rare diseases. To foster development in this area, the European Union’s orphan medicines legislation, launched in the year 2000, supports and promotes, through an incentive-based system, the development of quality, safe and effective medicines to treat these diseases. These are the orphan medicines. The incentives included in the orphan medicines regulation seek to encourage the development of products that would not otherwise be developed without this support. Medicines eligible to benefit from these incentives are identified through the orphan designation procedure, which is performed by the Committee for Orphan Medicinal Products (COMP), the scientific committee of the European Medicines Agency (EMA) responsible for recommendations on orphan medicinal products. In this webinar we will walk through the orphan designation process, from the first steps of initial designation to the last phase of maintenance at the time of marketing authorization application.

Gloria M. Palomo holds a BsC in Biochemistry and is an enthusiast of Neuroscience and Molecular Biology, which were the topics followed in her postgraduate studies. During her PhD studies at Universidad Autónoma de Madrid, Gloria focused her work on a rare neurodegenerative disease, Friedreich´s ataxia, where she uncovered a new mechanism underlying neuronal cell death and contributed to the proof of concept studies for the gene therapy in this disease. During her postdoc at Weill Cornell Medicine in New York, she worked on ALS and the pathological mechanisms of the disease associated with mitochondria quality control, especially mitophagy. Gloria M. Palomo is currently non-clinical assessor in the Vaccines and Advanced Therapies Service at the Spanish Agency for Medicinal Products and Medical Devices, and the member from Spain of the Committee for Orphan Medicinal Products of EMA.

* Recommended audience: professionals working in the field.

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