European Filing and Registration Procedures

This course will give participants the necessary overview of the applications and procedures used within Europe to grant marketing authorizations for medicinal products, as well as, the agencies and institutions which control the regulatory process. While special focus will be given to the European Medicines Agency (EMA) and its centralized procedure, the role of localized national health authorities and other EU bodies will be discussed in depth. The course will also cover topics relating to registration of specific groups of products such as orphan and pediatric medicines, as well as, advanced therapy and herbal product requirements.
The current regulatory climate will be discussed in depth and, from a regulatory agency’s perspective, will include examples of common filing deficiencies to avoid. Additionally, key differences between US and EU application dossiers will be examined in detail. This will also include an examination of emerging trends which are already affecting, or are likely to impact, future regulatory filing requirements.