REGULATORY NEW | ePI

October 20, 2023

Did you know that the first ePI has been published in the Product Lifecycle Management Portal of the European Medicines Agency (EMA)?

Check it out here! PRODUCT LIFECYCLE MANAGEMENT PORTAL- ePI

ePI refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print. It is the result of the ePI pilot project that started in July, 2023, managed by the EMA and a a group of its European medicines regulatory network partners (Denmark, the Netherlands, Sweden and Spain).

Need help for your regulatory affairs? Contact us! info@asphalion.com

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WEBINAR RECORDING | Reactivation of EMA Policy 0070: Introduction and key recommendations for a successful Publication

November 23, 2023

Watch Asphalion experts Ivette Camarasa and Nuria García Pazos in this webinar talking about EMA Policy 0070 and sharing key recommendations for a successful publication.

HORIZON | siNPAIN meeting in Barcelona

November 22, 2023

The objective of this project is to create a siRNA-combined advanced therapy, which will allow a more personalised treatment for different stages of osteoarthritis. All siNPAIN partners are working hard to develop efficient therapy to improve the quality of life of those affected by osteoarthritis, a chronic joint condition that affects more and more people every year.

Service | Readability test

November 16, 2023

Did you know that Asphalion can perform readability tests on your behalf? Asphalion has been providing its clients with the execution of readability tests

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