The alliance allows to effectively manage submission content, mitigate compliance risk and bring products to market faster.
As from 16 February 2015, the use of the web application for electronic entry of the Summary of Product Characteristics and Patient Information Leaflet is mandatory.
On 29 October 2014, EMA presented the final version of their guideline on biosimilars. This document replaces the previous guidance document of 2005, provides several clarifications and introduces one important change intended to ease global development of biosimilars.
European Comission: Notice to applicants, update of variations and renewal application forms (human and veterinary)
The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.
Over the years, this conference has become a real centre of attention for regulatory professionals and related life science experts.