IDMP Compliance Challenge and Regulatory Information Management
11-13 February 2015, Berlin, Germany
This exclusive marcus evans forum will offer critical insights into how to prepare for ISO IDMP pharmacovigilance legislation before it takes effect in 2016. More specifically, this conference will enable you to evaluate the impact of ISO IDMP and organise subsequent prioritization of key preparatory activities. Additionally you will learn how to manage RIM lifecycle of pharmaceutical products across multiple silo systems with very limited interoperability, as well as learning how to prepare IDMP compliance by figuring out data at hand and how to draw together data you do not have. Furthermore you will hear from leading industry experts how to draw and maintain information about packaged medicinal products to prepare for IDMP compliance and how to work towards a single, authoritative data repository. Finally, focus will be on learning from master data management projects supporting IDMP compliance and data harmonization across the group whilst building a well-integrated Regulatory Information Management system
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. In 2012, the five ISO standards referred to as “ISO IDMP” were approved. Their purpose is to standardise the identification of medicinal products, ultimately leading to improved pharmacovigilance across products, companies and jurisdictions. It has a global scope and in Europe for instance it will take effect by 2016.