The presentation “Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?” was given by Deborah Cooper, Vice President Consulting at GENPACT Pharmalink, at LORENZ userBridge.15 in Vienna, Austria.
In her presentation, Deborah Cooper discussed the impact of the ISO IDMP Implementation Roadmap on RIM strategies and presented the GENPACT IDMP readiness assessment for customers.
The ISO IDMP Standard and Iterative Implementation Roadmap
Based on EU Commission Implementing Regulation No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616). This should simplify the exchange of information between regulatory authorities, enhancing the interoperability of systems at EU level and internationally. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards.
Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in February and compiled this summary of the outcomes.
Representatives from EMA, NCA, industry, consultants and vendors participated in this meeting.
Referentials & Organisations
(click here to view the whole presentations: Referentials, Organisations)
Currently the Referentials Group is trying to create a common exchange process for distributing referentials lists. There are 2 different activity streams for each: 1) the gathering (or mapping of already existing data such as EVMPD) and 2) the distribution. For the latter, help from vendors will be needed on both the exchange process itself and for a User Acceptance Test (UAT) on building the exchange system.
Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group, compiled a short summary of current and future technology initiatives at FDA presented at the 2016 DIA RSIDM.
Brad Wintermute, the Deputy CIO and Director of the Office of Technology and Delivery at FDA, opened the 2016 DIA Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM) on Monday, February 8, 2016 by outlining current and future technology initiatives at the agency. It is very refreshing to see agency leadership not only paying attention to electronic submissions programs but identifying these programs as priorities essential to FDA’s mission.
Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in September and compiled this summary of the outcome.
The European Commission agrees to the Phased Approach
The transition phase will consist of two parts; the Pre-Submission Phase and the Submission Phase itself. Directly following that, the Maintenance Phase will begin.
The Pre-Submission Phase is planned to begin in July 2016 and to continue through the beginning of 2017, with three primary goals:
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.
The presentation “Implementation of IDMP is coming: Strategies for making the Business Case” was given by Dr. Andrew Marr, Managing Director of Marr Consultancy Ltd, at LORENZ userBridge.14 in Milan, Italy.
Dr. Andrew Marr is a well-known as a compelling speaker at userBridge conferences. Sharing more than 30 years of experience in regulatory affairs and regulatory operations, he acts as a leading consultant on xEVMPD and IDMP (Identification of Medicinal Product), and is also closely involved in the development of the ISO IDMP standard and guidance and was heavily involved in the current eCTD specifications. Continue reading