using compliance initiatives like idmp to drive forward information management strategy

White Paper

Using compliance initiatives like IDMP to

drive forward information management strategy

Date: 01-MAY-2016

Author:

Adrian Jones

[email protected]

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Using compliance initiatives to drive information management strategy change.

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Table of Contents

Introduction ..................................................................................................................................................... 3 The march of regulatory demand..................................................................................................................... 3

The current challenge. Where are we now? ...................................................................................................... 3 So, How do compliance programmes help? ....................................................................................................... 3 Looking beyond the regulation .......................................................................................................................... 4 Driving business advantage ................................................................................................................................ 4

Summary ......................................................................................................................................................... 5 Glossary ........................................................................................................................................................... 6


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Introduction Regulatory bodies are demanding more information from the industries they regulate. This trend often now requires the creation and submission of enterprise wide data sets to the regulator for analysis. How can we turn compliance related drivers into business value?

The march of regulatory demand.

The current challenge. Where are we now? Data integration strategy and information management within a sizeable organization can be difficult to define and even more difficult to implement. Larger organizations suffer from business and information silos, with their own governance models and their own agendas. Overcoming the organizational, political and sponsorship barriers is already a huge task, before a data integration strategy can even begin to be fully defined and ratified, let alone implemented. Before we can assess the technology aspects of an integration strategy there is much to be done. Unless there is a driver for change which impacts, and is acknowledged by, all stakeholders, the willingness to accept and implement change may be limited. Without an effective driver, agreements on data quality, ownership, provisioning and supply across business units and external partner organizations is difficult to achieve. In short there is no appetite for change. Funding for larger scale integration initiatives is difficult to obtain and business cases can be complex and challenging to quantify and justify in the eyes of the sponsor. Prioritization over compliance related and sales based initiatives can be almost impossible, often despite a high value return on investment case, usually in the areas of process improvement and operational efficiency.

So, How do compliance programmes help? How can we leverage compliance programmes to drive forward information management and data integration strategy? Most often compliance programmes are seen as a housekeeping or cleaning function driven by a regulator and having little or no value to the business itself. The perception is often one of “we have to do this because the regulator wants it, and if we don’t comply we will incur penalties.”. While this is true, many of the regulations are driven by a need for transparency and clarity of process, a clear need for validation and quality. Are these not drivers for our own businesses anyway? In recent times the regulators are imposing more far reaching regulations. These newer regulations require the submission of a much larger set of information, often cutting across many lines of business, such as R&D, manufacturing, finance and sales. Some examples of far reaching new regulations in the Pharmaceutical industry include IDMP, Serialization and the Sunshine Act. If we take, for example, the IDMP regulation coming into force in the Pharmaceutical industry, this cuts across regulatory affairs, product information, submissions and licensing, manufacturing, license partners and contract manufacturing organizations, and more. In order to meet the demands of the regulation we need a holistic view of product and the ability to be able to submit integrated information. There are, of course, a number of ways to achieve this. If purely looking pragmatically at a cleansing function then the data can simply be compiled in a database and submitted. For smaller


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organizations the possibility to manually submit datasets using an online tool is possible, however for larger organizations this is generally not a good option due to the amount of data and the complexity of the organizational structure. For these larger organizations, the compilation and submission of these cross functional datasets are a headache, requiring significant investment in solutions.

Looking beyond the regulation But there is more to this than meets the eye. The reason that these new regulations are causing organizations a headache is that they are addressing the same issues that need to be addressed in integration and information management programmes. In effect they are forcing the issue. This is the driver needed to create the appetite for change mentioned previously. Beyond that, there is great value to be derived from these integrated sets of information. Otherwise why would the regulator want this data? Then ask yourself, why would we not want the same insights derived from that information, and more, to help grow and make our own business more efficient? Why stop at the regulation? Greater insights can be derived from expanding the data sets and enhancing them with more information, so why not do so and utilize this internally. After all the submission data is only a subset of what you already need. Looking for opportunities to exploit the data internally is key to maximizing the value of the whole effort.

Driving business advantage The implementation of these new regulatory requirements ask many questions of an organisation and forces us to address multiple areas concerning the data to be submitted. These include:

• Data quality and completeness • Data governance, ownership and stewardship • Master data management and golden sources of information • Business definitions • Security • Legal aspects including data protection legislation • Organizational and Political aspects • Technology infrastructure • Etc …

Wait. Those are the same things we have been trying to address in our information management strategy! Utilizing the enforcement of regulations like these and integrating the consequent compliance programs into our overall information management and integration strategies will help to gain buy in from sponsors and release funding to pursue the wider goals. Using the compliance initiatives helps to provide clear cost avoidance based business cases to enhance and support the other parts of the business case, such as data exploitation, cost reduction, master data management, operational efficiency, etc. Avoiding a massive fine or other regulatory penalties is usually a sure fire way to get a business case approved. Integrating this into the overall business case for larger integration and information management programmes will raise the value of the business case and increase the chances of a successful and synergistic programme being approved.


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For example, imagine a business case with an already positive NPV /ROI , based on operational efficiency improvements from your integration project or programme alone, or maybe one that is difficult to acquire approval for due to a borderline business case or the significant budget requirement. By including the business case related to a compliance issue, which may incur a fine of 5% of gross annual profit, e.g. 20M USD, and the likelihood is high/inevitable by not pursuing the solution to the compliance initiative, instantly this positively enhances and supports the business case.

Summary Seek out the compliance initiatives ongoing across the enterprise and evaluate them in the context of the current or information management or integration strategy initiative and look for opportunities to integrate them into the overall programme.

• Seek out and identify planned or ongoing compliance initiatives. • Look for synergies between information and integration programmes and the compliance

initiatives. Roadmap the two together. • Aim to integrate compliance initiatives and their outcomes into the strategic programmes to

enhance business cases and generate higher value for the enterprise.


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Glossary Term Description EMA European Medicines Agency IDMP EMA Article 57 implementation. Identification the Medicinal

Product. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp&mid=WC0b01ac058078fbe2

NPV Net Present Value ROI Return on Investment

using compliance initiatives like idmp to drive forward information management strategy

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