Regulatory Master Data Management

User friendly and comprehensive data management for xEVMPD and IDMP compliance that includes seamless access to external systems such as GSRS, UCUM and EDQM.

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IDMP

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How Cunesoft supports you to overcome the IDMP challenge

 

The challenge for a successful IDMP implementation is the fact that structured data output is required, while the data sources and existing data are typically unstructured. Therefore, a key element for a successful IDMP project will be a comprehensive data source analysis. We recommend the following steps:

  1. Understand the ISO IDMP scope
    1. Iteration 1
    2. Beyond Iteration 1
  2. Assess the differences between the data submitted in xEVMPD versus IDMP
  3. Prioritize data gaps (mandatory, optional, conditional)
  4. Analyze data sources
    1. xEVMPD
    2. External databases (G-SRS, EDQM, UCUM, MedDRA)
    3. External partners (CMO, CRO)
    4. Internal (Medical, Clinical, Legal, PV, Regulatory)
    5. Internal systems RIM, ERP, LIMS, DMS, eCTD
    6. Legacy data: file shares, excel
    7. Documents
      1. Electronic
      2. Paper
    8. Collect sample data in order to determine the level of difficulty (i.e. collect data from an ERP system or an external business partner).

Cunesoft offers a structured Excel-based data analysis tool to its clients. The tool contains a structured list of all relevant ISO IDMP data fields, mapped with the available IDMP implementation guidelines.

Multiple Source IDMP Data Gathering

Automated IDMP data collection

  1. Connect directly to external data bases such as GSRS, EDQM, UCUM
  2. Connect directly to cune-eCTD or any other eCTD system for reuse of submission data
  3. Import historic xEVMPD- (and IDMP data) from past submissions
  4. Import data from excel files
  5. Invite external business partners (CMO, CRO etc.) to enter or upload their data via a secured external portal
  6. For all other data, make use of the user friendly datamart to complete data entry

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cune-IDMP information

Fact Sheet – cune-IDMP: Regulatory Master Data Management

Actual Data Mining POC Summary report (fully redacted): In this 26-page report you will learn about the overall project approach as well as the results. To receive the full POC summary report please apply here.

  • Workflow guided by wizards

  • Directly connects to external data bases such as GSRS, UCUM and EDQM

  • Edit data at any point in time during submission creation process

IDMP Software picture

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Software screenshot cune-IDMP
  • Manages xEVMPD submissions

  • Manages ISO IDMP submissions

  • Output format is compliant

  • Manages all relevant information for your pharmaceutical products

IDMP and xEVMPD Submission Publishing

 

HL7 compliant submission publishing format. Publish test submission at any time. Optional push of final IDMP data into your master data management system.

  • Create reports with a few clicks

  • Gather regulatory overviews via filters

  • Conduct “what if analysis” for implication check reports

IDMP Guidelines Datamart screenshot

 Powerful Reporting Via cune-IDMP

Reporting

100%

Comprehensive and powerful report generation engine. Create your personal reports and combine any data attributes within the system. Ideal for impact analysis and predictive analytics. i.e. What is the impact of changing an ingredient or an API manufacturer for a certain product in a certain region?

cune-IDMP and V.E.R.A.

Virtual Electronic Regulatory Assistant

 

Vera …guides first time users through each step of the software. …assists in getting documents stored in the correct folders … helps to prepare an eCTD submission. … guides on compliance fulfillment throughout the entire regulatory workflow …can do even more 

VERA…

…guides first time users through each step of the software

…assists in getting regulatory overviews via filters

… helps to create reports

… guides on compliance fulfillment throughout the entire regulatory workflow

…can do even more

Learn by doing

“This leads to a new dimension of user experience and work efficiency.”

Rainer Schwarz CEO Cunesoft

 

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IDMP: What is it and Why?

IDMP stands for the Identification of Medicinal Products and is a general term used when referencing the collection of ISO data standards – ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – that are being refined and implemented by regulatory bodies in support of improving pharmacovigilance via the soon-to-be mandatory submission of this data to health authorities.

In comparison to xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), the current legislative format, IDMP is substantially more detailed and complex.

By standardizing the structure and terminology used to describe healthcare products across all markets and all marketing authorization holders (MAH), the impact on health care delivery and patient safety has great potential:

  • Improved safety analytics across a broader spectrum of information
  • Globally identifiable product information
  • Complete product composition information
  • Enablement of information sharing between stakeholders

Legislative Status of IDMP

In order to successfully implement the collection of IDMP information via electronic submission, a staged or iterative approach is being utilized. This method can greatly improve the chances for success for such a monumental effort and also affords adaptability and flexibility throughout the entire effort. This graphic describes the current general timelines and iterations:

The next significant milestones in this plan are the following:

  • Publication of EU Implementation Guides 1Q/2Q 2017
  • Start of implementation of Iteration 1 for Products and Substances Q1/2Q2 2018
  • Enforcement of Iteration 1 for Products and Substances Q3/Q4 2018

It is expected that Iteration 1 requirements will include 79 data elements. The finalization of the implementation guides will describe the final list of required data elements.

Another critical aspect for this implementation is the establishment of the EMA’s master data roadmap resulting in the deployment and availability of a system of standards referred to as SPOR – Substance, Product, Organization and Referentials. The EMA describes SPOR as follows:

  • Substancedata, describing the ingredients of a medicine
  • Product data, describing the marketing and medicinal information relating to a product
  • Organization data, providing the contact details of organizations and individuals responsible for various aspects of a medicine
  • Referentialdata, providing controlled vocabularies (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) for a medicine, which are explicitly defined for use in Europe

EMA will launch the referentials management service in the third quarter of 2016, followed by an initial release of the organizations management service. EMA will continue to expand theses services incrementally after their initial launch.

Once these services are in place, stakeholders should start preparations to replace their 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. In parallel, EMA will implement the substance data and product data management services.

This master data management (MDM) initiative will provide future services around master data and enable the benefits to be realized through delivering value to stakeholders. Key goals for this project include:

  • Implementation of an integrated MDM solution which will deliver standards compliant master data for Substances, Products, Organisations and Referentials (SPOR)
  • Collection of data that will be managed and made available to the network, industry and wider stakeholder community, in compliance with legislative requirements and the relevant standards for privacy, data protection and security.
  • Implementation of a new portfolio of services which will be supported by standardised data governance and lifecycle management.
  • Optimization of program benefits realised throughout the implementation of the roadmap by involving and engaging effectively with stakeholders, leading to operating model simplification and efficiency improvements.

The objective of this whitepaper is to offer several best practices approaches on how to prepare your organization for IDMP compliance. Organizations of all shapes and sizes can benefit from the observations made in this document.

The Industry Challenge – Organizational Readiness for IDMP

The basic fact is simple: IDMP will become mandatory for every Marketing Authorization Holder (MAH). It is also true that IDMP will require the curation, management and submission of a much wider collection of data when compared to xEVMPD – for example, information such as clinical particulars, medicinal products, manufacturers, marketing authorizations, packaged medicinal products and pharmaceutical products. It is also very likely that the required data for these categories will come from several different data sources. One primary source will typically be company internal systems such as spreadsheets combined with data in internal regulatory information management (RIM) systems and other internal sources such as the ERP (Enterprise Resource Planning) system.

This internal data will need to be combined, harmonized and synchronized with data from official databases such as Global Substance Registration System (G-SRS[1]) previously known as Global Ingredient Archival System (GinAS) for substance related data, the Unified Code for Units of Measure (UCUM) for strength definitions and the Pharmaceutical dose forms, units of presentation and routes of administration (EDQM).

At Cunesoft we have analyzed of all required data fields defined within the ISO guidelines and offer the following results:

The proposed data elements include the following data entities:

The challenge of collecting and managing this broad array of data impacts the entire organization – not just Regulatory Affairs. Regulatory Affairs at both the headquarters as well as with affiliates will share data management responsibilities, product registration information, and ultimately own the harmonization of this ‘master data’.

Your CMC teams will need or want access to a substance database such as G-SRS or an internal IDMP-compliant system and they will also bear responsibility for collecting data about established substances in use with your products, possibly define new substances not currently found in G-SRS and interface with CMO’s to collect information about substances utilized from third parties.

Medical Affairs will be expected to provide information about clinical particulars – indications, interactions, undesirable effects – in support of and encoded within your SmPCs. Familiarity with and responsibility for coding terminology such as MedDRA, ATC and G-SRS will also be needed.

Finally, your supply chain, quality control and manufacturing functions will be impacted. From tracking licensing information for all manufacturers associated with your product to details related to packaging to awareness of and adherence to the registered physical characteristics of your products.

IDMP readiness and compliance will be an organizational responsibility and ultimate is a strategic initiative in most companies today.

Nearly all of the leading multinational pharmaceutical companies (i.e. the top 50 pharma) we have spoken with have defined IDMP as a strategic project and have allocated budgets ranging between 5 and 50 million Euro to accomplish IDMP compliance. Most of them have already completed their IDMP scope analysis and have started implementing methodologies to gather the relevant IDMP data from various data sources.

Best Practices for IDMP readiness

General Process Steps – How to eat an elephant?

With IDMP, there are and will be significant challenges to face and overcome. Yet, as with every journey, the first steps need to be taken. Or, in other words, answering the question “How to eat an elephant? The answer?  One bite at the time!

IDMP readiness can and should be treated as a formal project involving process steps that logically build upon each other. The recommended best practices project steps for IDMP are outlined below:

Scope Analysis – Analyzing your data sources

The challenge for a successful IDMP implementation is the fact that structured data output is required, while the data sources and existing data are typically unstructured. Therefore, a key element for a successful IDMP project will be a comprehensive data source analysis. We recommend the following steps:

  1. Understand the ISO IDMP scope
    1. Iteration 1
    2. Beyond Iteration 1
  2. Assess the differences between the data submitted in xEVMPD versus IDMP
  3. Prioritize data gaps (mandatory, optional, conditional)
  4. Analyze data sources
    1. xEVMPD
    2. External databases (G-SRS, EDQM, UCUM, MedDRA)
    3. External partners (CMO, CRO)
    4. Internal (Medical, Clinical, Legal, PV, Regulatory)
    5. Internal systems RIM, ERP, LIMS, DMS, eCTD
    6. Legacy data: file shares, excel
    7. Documents
      1. Electronic
      2. Paper
    8. Collect sample data in order to determine the level of difficulty (i.e. collect data from an ERP system or an external business partner).

Cunesoft offers a structured Excel-based data analysis tool to its clients. The tool contains a structured list of all relevant ISO IDMP data fields, mapped with the available IDMP implementation guidelines.

In the IRISS Forum’s 2016 Industry Survey on IDMP, over 80% of the respondents are currently conducting a gap analysis of their information assets. By conducting the data source analysis, you will be able to understand your information landscape and to identify your highest risk areas for gaps and complexities.

Create a business plan

Based on the data source analysis, it will be possible to determine the efforts and costs for collecting the relevant data from the best possible data sources.

The business plan should include a risk analysis, i.e. what happens if IDMP compliance is not achieved. (i.e. calculate the potential 5% penalty of annual net sales revenue as potential risk factor against the costs).

It is also important to include data visibility and related audit risks into the calculation. i.e. a broad set of data will be submitted to the authority.

While becoming compliant with IDMP requirements implies certain costs, it is equally important to build a base case that also identifies the benefits. Gathering a broad set of data such as the IDMP data is a very powerful source for regulatory reporting and improving organizational effectiveness. For example, drug efficacy can be analyzed on a much more granular (country or even patient) level and insights can be used to increase the overall drug efficacy and patient safety.

Using IDMP-savvy technology versus manual data entry

An important consideration for the execution of the IDMP project will be whether to perform the IDMP data entry manually, to outsource the curation to an outside firm, or to build/acquire a software tool to support the IDMP submission creation process.

In May 2015, Cunesoft conducted a survey with 75 life sciences companies across Europe. This revealed that more than 85% are considering the acquisition and use of a tactical software tool or a strategic software solution. Less than 5% plan manual data entry.

The IRISS Forum survey also looked into the intended technical approach for provision of IDMP data and found that 69% of respondents intend to submit the information via the gateway:

Mining your IDMP data from existing sources

The reality is that IDMP can be collected and entered manually. However, the reasons for using technology to gather and maintain IDMP are driven by initial and ongoing operational costs. The potential costs for manual data maintenance of hundreds of data fields per European market authorization can be significantly higher when compared to using usable and efficient software designed specifically for IDMP submission compilation and maintenance.

In terms of the initial curation of the data needed for populating IDMP information, recent technology innovations have made the concept of document data mining a reality. With a substantial percentage of the Iteration 1 data currently living in documents such as an SmPC, an opportunity presents itself to utilize intelligent document data mining technologies to automate the extraction and encoding of nearly half of the required data. Cunesoft’s cune-Distiller is a document data mining solution that is specifically configured to extract, encode and merge IDMP data from SmPC documents, xEVMPD files and even CTD documents such as those found in the 3.2.P section of a submission.

IDMP data mapping with coding systems

One of the new challenges with IDMP are coding requirements and controlled vocabularies. As described in a previous section, external databases will need to be used to map IDMP data with multiple standard coding systems.

Looking at iteration 1, for example, clinical particulars such as indications have to be extracted from the SMPC and also need to be referenced with the corresponding MedDRA codes, low level terms and SOC classifications. Active substances and Excipients used in marketed products need to be mapped with G-SRS codes. Additionally, other standard terminologies such as Dosage Forms, Organizations and Routes of Administration (to name a few) will have to be coded via yet to be released referential and organization data bases by the EMA.

IDMP data staging and curating

Following curation of the initial data, companies looking to utilize a technology solution consider management platforms that align with the IDMP data model and can produce compliant IDMP data files for submission.

Unstructured IDMP data, prepared as described in the section data mining and data mapping, will be required to be matched and staged with other structured data, coming from RIM, MDM, ERP or other systems.

Cunesoft offers cune-IDMP – a module in its Regulatory Operations Platform – with a growing number of companies across Europe utilizing the software to gather and manage their IDMP data. In nearly all cases, these companies have achieved an ROI in less than 6 months.

IDMP data maintenance and expected lifecycle

The entire IDMP data model includes 1200 data fields. Most likely, when reaching iteration 3, 500-750 data fields will need to be submitted and maintained. Manual maintenance of such large amounts of data will not scale. It is recommended that each IDMP project includes a strategy for ongoing data maintenance.

We fully expect that the IDMP submission life cycle management will follow the current xEVMPRM life cycle management, which include electronic message receipt of authority acknowledgments.

When using software technology for IDMP data maintenance, a gateway connector to facilitate the data transfer (send and receipt) to and from the health authority should be considered. Furthermore the software technology used should include business rules to manage data changes as automated as possible. For example, an alert should be sent internally to the IDMP responsible person, if IDMP relevant data is changing in any other system. Ideally such changes will automatically be updated by a well-designed IDMP software solution.

IDMP solved via Regulatory Master Data Management

Single Source of Truth

Master Data Management (MDM) approaches are being used in many organizations to create a single source of truth for related data. For example, the manufacturing division uses an Enterprise Resource Management (ERP) system, which contains production-related master data. Finance typically uses another instance or module of the ERP system or has its own finance master data system. Sales uses a Customer Relationship Management System (CRM), which consolidates all customer related data in one system for sales and marketing. In some case, the CRM system may be connected and integrated into the ERP system.

Within life sciences organizations, Regulatory Affairs has significant strategic importance. However, in most cases, no regulatory master data management systems are available or implemented. Unfortunately, in many companies, we have observed an Excel sheet-based regulatory data management approach.

Regulatory Information Management System (RIMS) have been the first attempt to manage broader regulatory data within a single system. In some cases, the existing RIMS environment can be the base for managing IDMP-related data, but would need to be customized significantly to also become the single source of truth. The graphic below describes the high level concept for a regulatory master data management.

Reduce IDMP submission time

With an information management platform specifically designed to meet IDMP data collection, validation and submission creation requirements, the process of actually producing an IDMP submission is quite rapid.

Reduce IDMP preparation time to a minimum

By leveraging a regulatory master data management approach, the re-use of data and metadata will be enabled. Data redundancies are eliminated. Data accuracy is guaranteed. Organization-wide data collaboration is achieved. External data providers (i.e. manufacturing partners) can also be integrated in the data collection process.

Increase working speed from hours to minutes

By providing users with unique process optimization features such as integrating external data bases (i.e. G-SRS, EDQM, UCUM etc.), the data collection and data management process are reduced. Familiar and useful task management allows users to distribute work items and track the completion of these tasks.

Reduce data maintenance costs by 70%

A solution designed with IDMP needs in mind can ensure automatic data updates via defined business rules as well as automatic data collection from any type of other internal source system.

Summary and Conclusions

Submissions of IDMP data for already approved products will become legislatively effective in Europe in mid-2017. FDA and Health Canada have given their commitment to ISO IDMP and are expected to follow with a legislative deadline shortly thereafter. And once the FDA publishes the legislative timeline, companies will have a 24-month window until the FDA legislation becomes effective. PMDA Japan is participating in international ISO IDMP update meetings and is expected to join IDMP as well. In other words, the conclusion can be made that IDMP will become a global standard.

Cunesoft recommends that all organizations see IDMP as a “opportunity for a strategic evolution”.  Publicly available studies confirm that for today’s pharmacovigilance related pharmaceutical product management, up to 100 minutes per product per year are being used to simply keeping the data up to date. With the increased complexity of IDMP, this yearly effort will increase by a factor of 3 to 5 times. According to a recent study conducted by the University of Leipzig, Germany, it is estimated that with master data management, the yearly maintenance time for comparable data records such as pharmaceutical product data, can be reduced to 20 minutes per year.

Therefore, when looking at the complexity of IDMP, the logical solution is the implementation of a regulatory master data management system that not only fulfills IDMP compliance requirements, but will also provide tremendous efficiencies – and savings –  for your regulatory information management.

Cunesoft can provide help with:

  • IDMP Training
  • IDMP Data Analysis Tools and Services
  • Business Case Creation Workshop
  • Regulatory Master Data Management Workshop
  • IDMP software cune-IDMP & cune-Distiller

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