Overview The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have proposed a phased implementation of the ISO IDMP standards. The phased implementation will release organization identifiers or controlled vocabularies in July 2016 Once implemented, EMA will replace its current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 common product model. This directory serves the EMA to allocate side effects reported via EudraVigilance to approved drugs and pharmaceutical companies. Before the Identification of Medicinal Products (IDMP) standard goes into force, companies must ensure that their XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) obligations are achieved. Information regarding any new registration should be notified to EMA in time of 15 days of approval using XEVPRM. Additionally, any changes to existing registrations, which relate to the relevant product information or other information stored in XEVMPD, should be conveyed in period of 30 days after approval. For submitting data to XEVMPD, a minimum of one individual from every company is required to complete the training and a competency assessment with EMA. Subsequent to this, an XEVMPD certificate is distributed allowing a user to register with Eudravigilance for: Electronic submission of information on authorized products and investigational medicinal products via the Gateway, or Data entry, maintenance and retrieval of information on authorized products and investigational medicinal products in the XEVMPD Freyr has achieved this certification and can be registered to support a MAH or sponsor in complying with this new legislation. Should you require assistance with XEVMPD, Freyr’s team of experts would be pleased to advice. In April 2015, the EMA has started to calculate pharmacovigilance fees based on the number of entries for XEVMPD. A technical guideline and user guidance specify what data needs to be reported to XEVMPD especially for smaller companies that can be a challenge because they generally don’t have the sufficient resources or capabilities to sustain XEVMPD. Freyr XEVMPD Management Software Freyr XEVMPD Management Software is a complete submission management solution that validates the product information and creates EMA compliant XML files. XEVMPD Management Software is easy-to-use, hosted, on-demand web-based solution with state-of-the-art information management features. EMA Updates on IDMP The approach to the implementation of the ISO IDMP standards is based on the EMA master data management roadmap. This roadmap outlines a multi-annual EMA programme for the use of medicinal product data related to substance, product, organization and referential (SPOR) data. The initiative aims to optimize and build on the current data governance, business processes and technology platforms in place at EMA, while considering wider stakeholder data requirements. Implementation Phases Implementation will be structured in three main phases: preparation, transition and maintenance. In the preparation phase, EMA will establish the necessary technical services to support the submission of organization and referential data. EMA will develop and release a set of controlled vocabularies (for pharmaceutical forms, routes of administration, etc.) and an organization dictionary. Meanwhile, EMA will continue to work closely with partners in the EU pharmaceutical industry and regulatory network to develop guidance to define the implementation phases and requirements of ISO IDMP norms and vocabularies in the EU (EU IDMP implementation guides) for the submission of data on substances and products. The transition phase will begin once EMA has released the organization and referential data services, and will emphasize on product and substance data. It will also involve two sub-phases: Pre-Submission for Product and Substance Data: Promotion authorization holders, national expert authorities and EMA should arrange their systems with the released terminologies for referential and organization data, and register any new terms to expand the controlled terminologies mandatory for the submission of medical substance and product data. Marketing-authorization holders will still have to submit in the XEVPRM format during this stage to meet the terms of their regulatory obligations under Article 57 of Regulation 726/2004. Product and Substance Data Submission: EMA will convert existing medicinal product and substance articles into the new HL7 format and support the industry in submission of IDMP products via the new format. Pharmaceutical companies will be required to verify this alteration executed by EMA, and to enrich the data with additional information. Later the XEVPRM format will be withdrawn and new format will be made compulsory to comply with Article 57 data submission requirements. The agency will announce a comprehensive plan entailing the information regarding what data needs to be submitted and will convey information about new format becoming a mandate to be followed. In the maintenance phase, EMA will develop and manage the controlled vocabularies for referential, organization and substance data within the respective data services. Consequent iterations of products will be applied as needed to complete the execution of ISO IDMP standards. XEVMPD/IDMP Conversion Changes Market Authorization holders (MAHs) requiring XEVMPD/IDMP XML Conversion services can utilize Freyr’s XEVMPD/IDMP conversion services to comply with EMA new PV legislation. Freyr’s XEVMPD/IDMP team has extensive experience and understanding of Drug product data fundamentals and business guidelines required to create XEVMPD/IDMP compliant XML file. Following is the validated process that is followed by our XEVMPD/IDMP conversion team to convert source documents into XEVMPD/IDMP compliant XML files. Key Benefits Guaranteed Compliance with EMA Guidelines and Business Rules 100% XEVPRM Compliant XML Generation Extended Support throughout the EMA Acceptance Process Extensive Domain Expertise in XEVMPD/IDMP related data elements Streamlined Standard Operating procedures and Conversion workflow Proof Reading with Guaranteed Quality Assurance Competitive Pricing XEVMPD and IDMP consulting services Freyr’s XEVMPD and IDMP consulting services include a comprehensive XEVMPD and IDMP strategy from organization readiness assessment, development of implementation road-map and process implementation. 1. Assess Organizational Readiness Number and Complexity of Products Current XEVMPD/IDMP data flow within the organization & across partners Data Sources and Data Fragmentation across the organization Regulatory Information Management Technology Components Compliance Expectations Time & Cost Commitments 2. Develop Strategy & Implementation Road Map Business Process Changes Product Data Ownership & Responsibility Commitments Interim Submission needs based on XEVPRM Migration to Final Submission needs based on IDMP needs Technical Approach to Current vs. Future State Data Flow Needs 3. XEVMPD/IDMP Process Implementation XEVMPD/IDMP Data Management & Maintenance Process (Data Collation and Data Mapping Processes) Implementation Submission Management and Workflow Implementation Regulatory Information Systems Implementation & Validation Key Highlights Onsite Consulting Services at your premises Ongoing real-time coordination with Freyr’s XEVMPD/IDMP Conversion Services team Saves Time Cost-Effective model Freyr’s XEVMPD Management Software Freyr’s XEVMPD management systems are easy-to-use, hosted, On-Demand web-based solution for information management for XEVMPD content authoring with state-of-the-art navigation and User interface components. The application was created keeping in mind the tedious data entry needs of large number of data elements required for complying with XEVMPD requirements. The application supports modular data entry screens based on submission components. This enables granular authoring and component level data entry validation. Data entered as components can be validated in modular fashion without having to wait for all the submission components to be completed. Freyr’s XEVMPD systems guides you with context sensitive helpful hints making your data entry process simple and error free. Reference look-ups are provided for appropriate data elements. It checks for data entry errors and all the required business rule validations as specified by EMA. The built-in validation engine checks for message integrity (technical checks) and scientific validation of data, thus ensures 100% EMA compliant XEVMPD XML file. Freyr XEVMPD has comprehensive security and workflow features supporting authoring, review, approve, publish and archival processes. Freyr’s XEVMPD supports life-cycle management of XEVMPD data created and submitted to EMA. It allows automated updating of EMA assigned EV code to local code mapping and enables XEVMPD management for future updates and communication to EMA The application tracks the changes and generates the updated delta XEVMPD compliant XML file. Product Features State-of-the-art Navigation & User Interface Components Assured Data Security from creation to storage Modular Component based Granular Authoring Comprehensive Security and Workflow Features Reference Look-ups Life-cycle Management Freyr IDMP on-Demand™ Solution With Freyr’s On-Demand IDMP solution companies can comply to EMA new PV legislation with minimal start-up costs. Companies don’t have to invest in overwhelming software license fees, infrastructure and training. No customer hardware or software is required. This solution offers a perfect low cost alternative to the conventional in house development or upfront purchase of IDMP software license. Key Benefits Ready-to-use, Web-Based, On-Demand Solution Minimal setup and Out-of-the-box solution Saves Time No Lead Time lost in ‘Building a System’ No Preliminary Implementation required Minimal start-up Cost Simple and Cost Effective Licensing Model Online Training and Support XEVMPD/IDMP 360 XEVMPD/IDMP 360 provides a comprehensive suite of software and services to enable Collection, Collation and Conversion of Data through: XEVMPD/IDMP Consulting : Includes Current state assessment, Development strategy and Implementation road map, and Business Process implementation. Freyr XEVMPD/IDMP Solution : A Comprehensive, web-based information management system which can be hosted or deployed on premises. It can also be used just as an information collation and repository system. When coupled with our XEVMPD/IDMP Convertor , the platform provides the framework required for an end to end enterprise scale XEVMPD/IDMP application. Freyr XEVMPD/IDMP Conversion Services : Based on the overall XEVMPD/IDMP conversion and maintenance strategy Freyr can undertake XEVMPD/IDMP XML conversion from diverse sources.