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How to Comply with IDMP Regulatory Requirements
The document discusses the IDMP regulatory requirements and the role of Perficient as a consulting firm in helping organizations comply with these standards. It outlines the history and goals of IDMP, the relevant ISO standards, and the challenges of implementing these regulations in the pharmaceutical industry. Key phases for project success include gap analysis, data gathering, and technical solution design, emphasizing the need for senior leadership support.
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How to Comply with IDMP Regulatory Requirements
- 1. HOW TO COMPLYWITH IDMP REGULATORY REQUIREMENTS
- 2. 2 ABOUT PERFICIENT Perficient isthe leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting, and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
- 3. 3 PERFICIENT PROFILE Founded in1997 Public, NASDAQ: PRFT 2015 revenue $473.6 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India >2,800 colleagues Dedicated solution practices ~90% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards
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- 5. 5 FEATURED SPEAKER Mark Thackstone SeniorBusiness Consultant • Specializes in the implementation, support, and development of software used in the collection, management, and analysis of medical product information data • Expertise in the EVMPD/IDMP arena • Many years of experience working in pharmacovigilance
- 6. 6 AGENDA • A briefhistory of IDMP • IDMP in Europe • Timelines and milestones • Is IDMP a problem? • What are the ISO standards? • Where is the data? • Solutions • Technological aspects • Organizational and project aspects • A introduction to the Oracle IDMP offering • Summary
- 7. 7 IDMP HISTORY • Likeall problems, started with • “I think things could be better.” • Since the 80’s – safety databases were growing • MCA/MHRA – Sentinel • FDA AERS • EudraVigilance • No common standard; meta analysis handicapped by the lack of common standards • ISO IDMP
- 8. 8 IN EUROPE… • IDMPfalls with in a series of initiatives under the EU Telemetrics Strategy • Other initiatives include management of clinical trials, monitoring of pharmacovigilance literature, provision of a single portal for drug authorization applications • IDMP is unique in several ways, • It is multi-disciplinary • It underpins several of the other applications • And it is part of a joint initiative between the members of the International Conference on Harmonisation (ICH)
- 9. 9 IN EUROPE… • Regulation(EC) No. 726/2004/EU, Article 57 & Regulation (EU) No520/2012 (articles 25 and 26) • Mandated that Marketing Authorisation Holders (MAH) are required to submit electronically information on all medical products for Human use • Since 02-Jul-2012 according to a standard described by the EMA – EVMPD • Since 16-Jun-2014 MAHs needed to update to a new standard– xEVMPD (eXtended EVMPD) • As of July 2016, MAHs need to move to the next standard • This standard is EVMPD compliant with the relevant ISO standards • DON’T PANIC – it is accepted that this legal requirement is unachievable and an incremental plan has been put in place reach the objective
- 10. 10 IN EUROPE… • Iwon’t say anything about the impact of Brexit! • Who knows what is going to happen next!!
- 11. 11 SO, WHAT ISIDMP? • EVMPD on Steroids! • Application of ISO standards to Article 57 product data collection • This standard was developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. It is one of a group of five standards which together provide the basis for the unique identification of medicinal products. • It provides data elements and structures for unique identification and exchange
- 12. 12 GOALS OF IDMP •Increased patient safety • Identification of counterfeit medicines • Enhanced signal detection • Increased transparency • Increase consistency of the regulation of pharmaceuticals • With in the EU • With the USA (and ultimately other regions that adopt ISO IDMP.
- 13. 13 Industry and Medical Research CompetentAuthorities EXCHANGE AND INTEROPERABILITY USA FDA EMA Pharma CompanyRegulators / Medicines Agency Sponsor Other Stakeholders Health Service providers – e.g. NHS Other Agents e.g. CROs Assignment of new substance identifier
- 14. 14 ISO STANDARDS ISO 11615 Healthinformatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information ISO 11240 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement ISO 11238 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances ISO 11616 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information ISO 11239 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
- 15. 15 ISO STANDARDS Product Package ISO11616 regulated pharmaceutical product information ISO 11615 regulated medicinal product information ISO 11238 substances
- 16. 16 ISO STANDARDS Product Package ISO11239 dose forms, units of presentation, routes of administration packaging ISO 11240 units of measurement ISO 11616 regulated pharmaceutical product information ISO 11615 regulated medicinal product information ISO 11238 substances
- 17. 17 IDMPMPID Version Medical Product Name Marketing Authorisation Marketing Authorisation Procedure Manufactoring Authorisation Holder:Organisation Holder :Organisation Regulator : Organisation Authorisation Authority : Organisation PCID Outer Packaging Physical Characteristics Package Item Package Item Package Item Part Package Item Part Package Item Part Substances Manufactured Item Ingredient Specified Substances Substances Substances Strengths Strengths Strengths Reference Strength Pharmaceutical Product Ingredient Specified Substances Substances Substances Strengths Strengths Strengths Reference Strength Route of Administration Indications PhPID
- 18. 18 SPOR AND MASTERDATA MANAGEMENT • One thing that is apparent is a large amount of the data is shared or common • Some of these data types are well defined, controlled, and managed in dictionaries and code lists • MedDRACountry and language lists (ISO 3166 and ISO 639) • International units • ATC • Where these exist IDMP adopts them • However what to do about those that are common data points, but are not defined? • This was one of the lessons learned from previous iterations of the Art. 57 database, and the EMA have accepted responsibility for organizing and harmonizing codes for data points such as substances
- 19. 19 SPOR AND MASTERDATA MANAGEMENT Referencials Organisation Products Substances• Substance - describing the ingredients of a medicine; • Product - describing the marketing and medicinal information relating to a product; • Organisation - providing the contact details of organisations and individuals responsible for various aspects of a medicine; • Referential, 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.
- 20. 20 TIMELINES AND MILESTONES •The legal deadline for the move to IDMP is July 2016…but don’t panic! • Following the experience of the regulators and the industry, this was identified as unachievable • The EMA has developed as strategy of moving in stages or Iterations • The first Iteration is planned to kick off in Q2 2018 and become enforceable Q4 2018
- 21. 21 TIMELINES AND MILESTONES ReferentialSubstances ProductsOrganizations Iterations
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- 23. 23 Form •Paper •Electronic documents •Structured fields Location •Regulatory affairs •PV •Sales •Clinical Repository •SAS •Spreadsheet •Database Provenance •Newproducts •Old products •Legacy products •Authoritative source IDMP Data •MPID •PhPID •Substance •Unit IDMP DATA All these data attributes have to be taken into consideration One IDMP record might be made of data elements that come from diverse sources
- 24. 24 Form •Paper •Electronic documents •Structured fields Location •Regulatory affairs •PV •Sales •Clinical Repository •SAS •Spreadsheet •Database Provenance •Newproducts •Old products •Legacy products IDMP Data •MPID •PhPID •Substance •Unit IDMP DATA These data points are not static and move within their own quality management systems – the status of the data within the life cycle needs to be considered. The same data points can also exist in multiple sources, therefore it is necessary to identify the authoritative source, or if you use a secondary source, you need confirmation of its veracity against the primary.
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- 27. 27 SOLUTION PHASES Project Plan/ Solution design Gap Analysis Data Gathering Technical solutionbuild and validation IDMP delivery Maintenance
- 28. 28 FULL PRODUCT LIFECYCLE - MAINTENANCE CTA Withdrawal MAH Development Marketed 1. Triggers for a new or updated record? 2. How to make update? 3. QMS? 4. Metrics/Oversight
- 29. 29 DBs DBs DBs IDMPIDMP Solution WHERE DOYOU WANT TO END UP? DBs DBs DBs IDMPIDMP Solution IDMP Solution DBsDBsDBs IDMP Master Data Management Regulatory Information Management
- 30. 30 WHERE DO YOUWANT TO END UP? Advantages Disadvantages Master Data Management • Possibly faster • Doesn’t require different departments to change their processes • Policing the master data • Poor control • Need to maintain multiple systems Regulatory Information Management • Maintenance of a single repository • Intrinsic master data management • Inter-departmental inertia • Costly • Potentially slower to deploy • May not meet niche needs IDMP IDMP MDM RIM
- 31. 31 TEAMS Design and Build •Existingheadcount •Multi-disciplinary teams •Business SMEs, IT & Project Management •What about their day jobs? •IDMP-focused teams •Budget •Do you have the necessary expertise? •External support/Consulting IDMP processing •Extend existing roles •Training/Procedures •Resource – do you officers have enough time? •Dedicated IDMP department LEADERSHIP
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- 33. 33 SUMMARY • IDMP isthe application of ISO standards to the Art 57 (EVMPD) Medical Product Dictionary • It is a legal requirement in the EU from July 2016, but it is being released in iterations. • Time lines are short and guidance is unclear. • Gap analysis, Data gathering, technical solution design are key early phases for project success, but don’t lose sight of the long term solution and ensure to factor in the people and procedural component • Because of the nature of the project – support of senior leadership is critical for success.
- 34. 34 QUESTIONS Type your questioninto the chat box
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Editor's Notes
- #7 Evi slide
- #8 So, IDMP, the Identifications of Medical Products, Like all problems down through history, started with, someone, somewhere thinking to themselves, “hmmm, I think things could be better” Now I don’t know if it was some lonely regulator buried under paper in some medicines agency; I don’t know if the idea came to multiple people at different times and faded away, and I don’t know how it came to be but gradually this idea developed a head of steam and started to change from a meme into an tangible project. So what was the problem? Since the 80’s safety database were becoming prevalent around the world, collating large amounts of important safety data, and they have been responsible for the identification of many important safety signals. But while these databases were useful, it was obvious that if it were possible to combine these disparate databases, far more powerful statistically analysis could be performed. Also, even if the database remained separate, if they were to remain separate, signals found in one database could be verified or corroborated in another, if it was know that the database were homogenous, and constructed according to the same rules.
- #12 So those of you who have been through the mill before, IDMP is EVMPD on Steroids Application of ISO standards to Article 57 product data collection This standard was developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. It is one of a group of five standards which together provide the basis for the unique identification of medicinal products. It provides data elements and structures for unique identification and exchange
- #15 So ISO IDMP is made up of a cluster of 5 separate standards. ISO 11615 deals with Regulated medicinal Product Information and gives us the MPID – Medical Product Identifier ISO 11616 Deals with the regulated pharmaceutical product information and gives us the PhPID – So you are probably wondering what’s the difference between the MPID and PhPID – well hold that thought and I’ll try and un pick that in a moment. ISO 11238 deals with the substances that make up medicinal products ISO 11239 defines how to describe dose form, units fo presentation, routes of administration and packaging. And lastly, ISO 11240 describes how units of measure will be incorporated into the IDMP ISO standard.
- #16 So how does IDMP related to the real world? Imagine you had a headache and you reach into the medicine cabinet for some analgesia – and in you hand is a small box. You look at the box and it has all kinds of information on it. Probably the first thing you see is the brand name. If you have any kind of medical background you skip over this and look at the generic drug name, and the strength and formulation. If you working in pharmacovigilance you look to see who the manufacturer is. Already I think you would agree, we have encountered a huge amount of information and we haven’t even opened the packet yet. What ISO IDMP does is describe all this information in a standardized way. We open the box and pull out a strip of tablets in their blister packet and pop a couple of tablets out. Now they look fairly no descript – but still they are amazingly complex objects – ISO IDMP has a way to describe them – so we know their pharmaceutical product characteristics – from the outer coating of the tablet right down to the chemical structure level. So ISO 11615, dealing with the Regulated Medical Product Information gives us the registered detail of that specific licenced product and allocates it an MPID (code). ISO 11616 describes the pharmaceutical product and for want of a better term this is the generic information – what’s common to say Ibuprofen from one company verses another company. This is the PhPID. There is a relationship between the codes –part of the data associated with the MPID is the pharmaceutical product – so the PhPID is referenced and part of the MPID data set. In this way we can cross reference different aspects of the data constellation.
- #17 In addition to this ISO IDMP gives us standards for how we describe these entities- what constitutes a particular dose form, how we record the route of administration and how we can describe the packaging. And so that we can qualify all this information, ISO IDMP gives us a standard for units of measure. Now we all know that units of measure exist outside ISO IDMP, so this standard describes how units will be incorporated into IDMP reports, provides mappings between different unit vocabularies and languages(Translations) and provides traceability back to the reference standard.
- #18 So when all the data points are gathered together ISO IDMP organizes this information into a constellation of interrelated and cross referenced data points, which can be mapped out something like this. Now please note this is an extremely simple version of an IDMP report, which does not extend to the lowest levels of complexity. For example if we where looking at a biosimilar or a vaccine, potentially information under stub stances could be far more complex.
- #21 The legal deadline for the move to IDMP is July 2016….but don’t panic! Following the experience of the regulators and the industry, this was identified as unachievable. The EMA has developed as strategy of moving in stages or Iterations. The first Iteration is planned to kick off in Q2 2018 and become enforceable Q4 2018 The lag between release of guidelines and the kick off is minimal so industry is expected to design it’s solutions from first principles and then tweak it to fit the EU interpretation of IDMP> THIS IS GOING TO BE TIME PRESSURED The best time to plant a tree is thirty years ago, the second best time is now. – if you haven’t already started, you should asap.
- #22 So once it was decided to move forward in iterations, it had to be decided what would be in each iteration. This went out to consultation between the EMA and a selection of member states, - there was a scoring process and in upshot was 79 data elements were identified as necessary. I don’t believe this has been formally published as yet so this is a working list. This is road map from the EMA website and I have just put it up for illustrative purposes to demonstrate that there a lot of moving parts!
- #23 So once it was decided to move forward in iterations, it had to be decided what would be in each iteration. This went out to consultation between the EMA and a selection of member states, - there was a scoring process and in upshot was 79 data elements were identified as necessary. I don’t believe this has been formally published as yet so this is a working list.
- #24 So IDMP is data, just data and only data, right? Wrong, when you start getting into the portfolio, you realise that the data has dimensions that you may not have considered import that have a direct bearing on the IDMP project. All these data attributes have to be taken into consideration. One IDMP record might be made of data elements that come from diverse sources. For examples: on product might have the product name in the structured fields in the regulatory affairs database, but the indication is in text in the SmPC which is an electronic document based on the Core labelling which is controlled from Pharmacovigilance. Artwork have the packaging information and the marketing status is maintained by Sales on a SAS database. Manufacturing hold the information about the excipients except for one which is bought in house from an external supplier who hold the substance information on paper. That’s for one product. Across a companies portfolio, this could be repeated in multiple variations. A factor critical to IDMP success is getting a measure of the portfolio data universe using these dimensions
- #25 These data points are not static and move within their own quality management systems – the status of the data within the life cycle needs to be considered. The same data points can also exist in multiple sources, therefore it is necessary to identify the authoritative source, or if you use a secondary source, you need confirmation of its veracity against the primary
- #29 IDMP follows the entire product life cycle – from development through to withdrawal. The important point to note is this is an iterative process and leads to 4 points that need to be addressed, How do you know you need another iteration? This breaks down into 2 part – a) what constitutes the threshold for creating another iteration and b), how will you know that you have reached that threshold to trigger the update? – is it going to be automated in your IT solution or is it going to be part of a business process. Scale and organization of the company are factors that come play here – for example a change in the marketing status of a product would be know in the sales department of a company, but how does that information get to the IDMP team? To accurately address this, it is important to look at the business process as well as the IT solution. How do you make and track the updates? Who’s going to do it? Is it the data owner/authoritive source – remember people who use a system occasionally are more likely to make mistakes – so will the updates to their native system get transmitted to the IDMP system? Or will the changes get communicated to the IDMP data entry team – who are specialists but who will manage the logistics of the communication? QMS – Quality management system – Some quality checks can be programmed in, but who is going to reconcile the source data against the output? Management metrics – what views, dashboards reports and processes in place to identify bottle necks early and ensure that compliance is maintained.
- #30 So we have talked about solution phases and the basic architecture of a solution – basically you need to drag together a wide variety of data points from disparate and far flung sources, you’ve squeezed it all into an IDMP report, flung it through the gateway, the EMA have uploaded it into their database. Their happy, you’re happy, you can go back to saving the world by making those vital medicines and the regulators can go back to whatever they do…right? Well, not entirely. The problem is, data doesn’t stay the same, it changes. Drugs get new indications, naming conventions for substances change, you may switch manufacturer for an excipient, or you may want to move your registered office (if you are thinking of leaving the UK, please don’t! So the data needs maintenance, and as those changes happen, every time those changes happen, that whole procedure of getting the information in to IDMP starts again. Now basically there are 2 strategies. The first one is that you continue to use your existing databases and whenever there is an update in one, it gets fed into the IDMP solution. Alternatively, once you have all your data in one place, why not keep it there? Retire your old database, and have massive system for every one to used.
- #31 So we have talked about solution phases and the basic architecture of a solution – basically you need to drag together a wide variety of data points from disparate and far flung sources, you’ve squeezed it all into an IDMP report, flung it through the gateway, the EMA have uploaded it into their database. Their happy, you’re happy, you can go back to saving the world by making those vital medicines and the regulators can go back to whatever they do…right? Well, not entirely. The problem is, data doesn’t stay the same, it changes. Drugs get new indications, naming conventions for substances change, you may switch manufacturer for an excipient, or you may want to move your registered office (if you are thinking of leaving the UK, please don’t! So the data needs maintenance, and as those changes happen, every time those changes happen, that whole procedure of getting the information in to IDMP starts again. Now basically there are 2 strategies. The first one is that you continue to use your existing databases and whenever there is an update in one, it gets fed into the IDMP solution. Alternatively, once you have all your data in one place, why not keep it there? Retire your old database, and have massive system for every one to used.
- #32 It’s all very well talking about technological solutions but sooner or late its going to have to involve that other dimension- People. You can break this down it to 2 phases or parts Who is going to build it And Who is going to work it. Looking at the build are you going to use existing headcount? Because of the nature of IDMP it’s going to be a multi displinary team – SMEs, IT PM. – Who is going to do there day job? This is a big project so they are not going to be around as much as they were. May be you will carve them out entirely and have a dedicated IDMP team. You need to think about budget – are you going to be able to quickly access this – remember budgets are defined a year in advance. You might want to think about pulling in external support – consultants can be very useful – they have a broader view point of what is going on in the industry and sometime the independence from the internal pharma company structures can be useful. Secondly, you need someone to do the work. – You either want to extend existing roles, in which case you are going to need to train them and revise their procedure. Also, have a good look at the amount of work they will need to do – you will probably need to revise resource levels and performanace metrics. Alternatively, you may want a dedicated IDMP department – you might feel that it is adventagous to have an in house (or out house) team of experts. Lastly. – LEADERSHIP This is going to be difficult This is going to be big This is going to be complex This is going to be time pressured. It will involve a lot of different people and department going through change You need at least the support and sponsorship of the most senior person that you can get to listern to you. I’m not thinking the QPPV or the head of regulatory, I’m thinking the a senior president or the CEO - someone who holds sway over all the departments that IDMP is going to make life difficult to for the next 2 to 4 years. It might be a difficult conversation, but the conversation could be more difficult later!
- #33 So, let’s take a brief look at Oracle’s proposed offering to support clients in the realm of IDMP. So those of us who have engaged with Oracle before might be seeing some familiar faces here. This is because Oracle solution is built around leveraging 4 existing platforms. Agile – Data repository. OBI (Oracle Business intelligence) - Dashboard EQD (Enterprise Data Quality TMS – Dictionary Management. So by doing this, Oracle is giving us all the components that are needed to meet the technological needs for IDMP. An then there is a 5th component the IDMP Enterprise Foundation Pack - this is the module that will bring together all the other functionality and turns it into a machine to meet the IDMP challenge. Or at least that is the plan. I know Oracle are busy bringing this to market, they launched it in DD-MMM-YYYY, and we are eagerly awaiting further developments.