Keywords: Identification of medicinal products (IDMP); Regulatory information management (RIM); European Medicines Agency (EMA); Cross-functional integration; Enterprise architecture (EA); Master data management (MDM); Information services bus; Data warehouse.
Abstract: The need for end-to-end visibility of regulatory information
has been the driver for implementing integrated regulatory information management (RIM) solutions within the pharmaceutical industry. The European Medicine Agency’s identification of medicinal products (IDMP) requires even greater integration across multiple functions and systems such as regulatory, labelling, safety, manufacturing, supply chain, clinical and quality. In addition to meeting the EMA’s compliance requirements, it is believed that IDMP is coming at a time when there is need for end-to-end information integration across the pharmaceutical value chain.
This paper describes how an enterprise architecture (EA) approach is best suited to integrate multiple systems together across multiple functions. It discusses the relevance of three EA constructs, namely, master data management (MDM)
for managing a single source of truth around product data, information services bus for the purposes of integration and a data warehouse to manage integrated data for aggregated reporting.
Introduction:
The European Medicines Agency (EMA) is gearing up towards the implementation of the ISO identifcation of medicinal products (IDMP) with a target deadline for full implementation being moved from July 2016 to Q4 2017 for medicinal products and Q2 2018 for investigational products [1]. The IDMP standard comprises five major standards covering a broad set of pharmaceutical information such as medicinal product, packaged medicinal product, pharmaceutical product, ingredient/ substance information, clinical particulars, authorisation, manufacturing information, dosage form, route of administration, packaging, units of measurement, etc. Industry is preparing in terms of performing readiness assessments, data gap analysis and other activities while simultaneously trying to understand the real scope of implementation by the EMA [2]. In a previous article in Regulatory Rapporteur, Joel Finkle provided an overview of the IDMP standard as a data format capturing product profile, safety, packaging, authorisation, manufacturing and related key information to be submitted to the EMA and other regulators worldwide [3].
IDMP poses several challenges to the pharmaceutical industry, the key being the ability to integrate disparate data from multiple systems managed by multiple functional areas within an organisation. While being a technology and an integration challenge, IDMP also poses organisational and political challenges given that it requires the collaboration and cooperation among many functional units, which have been traditionally independent and siloed for a long time.
This paper proposes that industry looks at IDMP as an opportunity for enterprise integration of information across the pharmaceutical value chain, offering insights into how such integration could be accomplished using established EA approaches. This article is geared towards regulatory operations and information management professionals who are part of regulatory affairs organisations, as well as IT professionals supporting regulatory in building capabilities to support the needs of regulatory affairs and operations. The article builds on the EA approach to IDMP presented by the author at the DIA EDM/ERS Conference in 2014 and also the relevance of Master Data Management to IDMP presented by the author at the DIA eRegulatory and Intelligence Conference in 2015 [4, 5].
References
- ISO. IDMP Standards 11238, 11239, 11240, 11615, 11616. Available at: www. iso.org/iso/home/store/ (accessed 17 May 2015).
- EMA. Implementation of Article 57(2), Second subparagraph of Regulation (EC) No 726/2004. Available at: www.ema.europa.eu/docs/en_GB/ document_library/Presentation/2012/05/WC500126849.pdf
- J Finkle. ‘Planning for Successful IDMP Implementation’, Regulatory Rapporteur, Vol 11, No 14, October 2014.
- V Balasubramanian. ‘An Architectural Approach to IDMP’, DIA EDM/ERS Conference 2014, September 2014.
- V Balasubramanian. ‘IDMP as a Business Driver for Master Data Management’, DIA eRegulatory and Intelligence Conference 2015, May 2015.
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