European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements
November 13 - 14, 2014 - Berlin PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
This course will give participants the necessary overview of the applications and procedures used within Europe to grant marketing authorizations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be on the European Medicines Agency and the centralised procedure, with the role of the national health authorities and other EU bodies in the mutual recognition and decentralized procedures explained also. The course will cover topics relating to registration of specific groups of products such as orphan and paediatric medicinal products, as well as advanced therapy and herbal product requirements. The current regulatory climate will be discussed in depth with examples of common filing deficiencies and how to avoid them, provided from the regulator’s perspective, as well as highlighting key differences between US and EU application dossiers. The impact of key emerging trends already affecting or likely to impact on regulatory filing requirements in the future will be discussed.