Over more than a decade, the LORENZ userBridge Conference has grown to become THE conference for learning all about current e-regulatory affairs. Speakers are recruited from the highest levels of the regulatory affairs world, and topics are selected for their timeliness and relevance to our customers. This year you’ll find IDMP, RIM, and process optimization all on the agenda, as well as the status of eCTD in different countries around the world, and a wide range of other current issues.
Participating in the ISO IDMP Task Force and in consultation with a variety of other stakeholders, we have formed a proposal on how the ongoing EMA planning could be interpreted from an industry perspective.
The European Medicines Agency (EMA) and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU. LORENZ is taking part in the ISO IDMP Task Force (TF) which has been established to advise on the planning, development, implementation and maintenance of the EU’s ISO IDMP standards. This Task Force met on Friday, 12 June. Based on that meeting and on other discussions with a variety of stakeholders, a proposal has been developed on how the EMA’s planning could be interpreted from an industry perspective. It should be noted that the official implementation date remains 1 July 2016. However, there is currently only one timing plan being worked on, and this foresees a phased approach to implementation. The picture above illustrates these proposed high level implementation timelines.