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RIM & IDMP Synergies

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RIM & IDMP Synergies

  1. 1. © 2017 PAREXEL INTERNATIONAL CORP. RIM & IDMP SYNERGIES Like fish and chips…you shouldn’t have one without the other
  2. 2. © 2017 PAREXEL INTERNATIONAL CORP. / 2 AGENDA • Life Sciences Regulatory Processes • RIM in relation to the processes • IDMP in relation to the processes • Moving toward more data centric requirements • Groups actively working in these areas • DIA RIM Working Group • IRISS IDMP Working Group
  3. 3. © 2017 PAREXEL INTERNATIONAL CORP. / 3 LIKE RIM AND IDMP - THINGS THAT GO TOGETHER • Spaghetti and Meatballs • Peaches and Cream • Bread and Butter • Bacon and Eggs • Macaroni and Cheese • Peanut butter and Jelly • Salt and Pepper • Up and Down • Back and Forth • Yin and Yang • Pros and Cons • Hide and Seek • Lock and Key • Song and Dance IDMPRIM
  4. 4. © 2017 PAREXEL INTERNATIONAL CORP. / 4 REASONS TO THINK ABOUT RIM AND IDMP TOGETHER IDMPRIM
  5. 5. © 2017 PAREXEL INTERNATIONAL CORP. / 5 VERY BASIC REGULATORY PROCESS MAA NDA NPD R&D
  6. 6. © 2017 PAREXEL INTERNATIONAL CORP. / 6 PROCESS CONTINUES – LIFECYCLE…. Renewals PV ETC.. Variations Advertising/ Labeling
  7. 7. © 2017 PAREXEL INTERNATIONAL CORP. / 7 WHEN RIM BEGAN – WAY BACK IN 2003 • Initially created as an “add on” to publishing: • Key data points from the dossier tracked in a database for easier reporting • Designed to capture product data as well as to compliment data for Submission Processes • Managing and tracking regulatory business processes by tracking process data » Managing and tracking submission milestones – planned and actual dates » Relationships to number of submissions it took to get approved » Relationships of tasks and assignments associated to submissions • Product data and changes to the data are tracked as part of a submission/regulatory action – Managing and tracking product details related to the specific submissions where changes occur – Tracking what was approved or not-approved or rejected or……. • Standards for defining product were still emerging
  8. 8. © 2017 PAREXEL INTERNATIONAL CORP. / 8 MOVING TOWARD PRODUCT MODEL STANDARDS • XEVMPD becomes a requirement in the EU • XEVMPD can easily be a subset of RIM data • IDMP standard emerges greatly expanding product data model beyond “standard” RIM • BUT….. • IDMP is related to the Lifesciences regulatory process • Planning, tracking, managing data around regulatory activities and Medicinal Products • What companies want to track for internal needs • The data agencies will start asking for in the form of data and not just documents • IDMP extends the data beyond what was consider RIM in the past • You shouldn’t really think about IDMP without thinking about RIM
  9. 9. © 2017 PAREXEL INTERNATIONAL CORP. / 9 RIM AND IDMP DATA FLOW • In a way, the data follows the process • Or goes hand-in-hand with the process • Regardless – tracking the data that goes along with a regulatory process or change, has grown in importance • And is growing in content and need • Compliance and quality are and will continue to be extremely important • Agencies often assume that if the information is in a document…. it can easily be provided as data…. – If only it were true……
  10. 10. © 2017 PAREXEL INTERNATIONAL CORP. / 10 IDMP IS BECOMING THE HEART OF REGULATORY DATA INITIATIVES GOING FORWARD IDMP ICSR E2B(R3) ePrescription (Open Medicines) eApplication Falsified Medicines Directive Serialization eDispense SPL Regulatory Submissions EU Sunset Clause Etc.
  11. 11. © 2017 PAREXEL INTERNATIONAL CORP. / 11 IDMP – LONG TERM VISION FOR SUBMISSIONS • Operating Model Vision for IDMP – IDMP files as part of a regulatory submission – Reviewers actually using IDMP data instead of or in tandem with documents where it makes sense » Ex: Changes to manufacturer name and location – Requiring information currently in a text format transformed into data format » Ex: Clinical Particulars (ex: Indications as codes instead of text) • Expectation that other countries/regions will be rolling out IDMP
  12. 12. © 2017 PAREXEL INTERNATIONAL CORP. / 12 DATA PROJECTS AND PROCESSES ARE CONVERGING • The goal is for IDMP to be the global standard used for defining Medicinal Products • Agencies will expect: • To receive the same exact values for the same exact field regardless of the type of data submission or reference to the field • To do analysis across what used to be disparate systems • Companies to have validated data fields across their sources and systems • Companies will benefit: • Less data discrepancies across systems/platforms • Better collaboration across the organization • Higher confidence in data assets • Have a true global view of Product Information and Intelligence
  13. 13. © 2017 PAREXEL INTERNATIONAL CORP. / 13 RIM AND IDMP DATA FLOW • For RIM systems the challenge has always been with exactly what data to track • Although we can probably all agree on some standards – There are still often company specifics • IDMP Data • It is a Standard – Companies can decide how to roll it out – but it only makes sense to use a standard product model instead of defining your own….. • It’s helpful to have a data model and the beginnings of some agency requirements • IDMP is going to be the standard for data submissions and tightly integrated with other agency requirements and initiatives – Companies can do assessments of where data resides using IDMP as a blueprint
  14. 14. © 2017 PAREXEL INTERNATIONAL CORP. / 14 REGULATORY INFORMATION SOURCES Regulatory Information eDM Content (Clinical, CMC, Safety, etc.) Supporting Data (clinical, nonclinical, etc.) Registration Information (submissions, licenses, etc.) Promotional Information (advertising, claims, etc.) Commercial Information (safety, distribution, etc.) Regulatory Intelligence (regulation changes, competitors, etc.) Labeling Safety, Benefit Risk 14
  15. 15. © 2017 PAREXEL INTERNATIONAL CORP. / 15 PROCESSES AND DATA FLOW WORKING TOGETHER 15
  16. 16. © 2017 PAREXEL INTERNATIONAL CORP. / 16 RIM & IDMP Clinical Documents Labelling Product Safety Manufacturing Marketing Etc. SYNERGY BETWEEN RIM AND IDMP AND SOURCES RIM IDMP
  17. 17. © 2017 PAREXEL INTERNATIONAL CORP. / 17 RIM AND IDMP RIM and IDMPFish and Chips IDMPRIM – like fish and chips you shouldn’t think about one without the other
  18. 18. © 2017 PAREXEL INTERNATIONAL CORP. / 18 IRISS IDMP TOPIC GROUP • Implementation of Regulatory Information Submission Standards (IRISS) • Identification of Medicinal Products (IDMP) Topic Group • IDMP Topic Group started March 2012 • Purpose of the Group: – To support the implementation of the ISO IDMP Standards – Shorter term support for the implementation of XEVMPD in Europe • Monthly Teleconference Meetings • Input to EFPIA and EU Task Force for EMA discussion • Linked In Group http://www.iriss-forum.org/page-index.html
  19. 19. © 2017 PAREXEL INTERNATIONAL CORP. / 19 DIA RIM WORKING GROUP • Industry professionals working to identify common elements of RIM and define industry standards accordingly • Seeks to explore emerging disparate RIM issues –Widely varying terminology –Non harmonized definition of “Core RIM” –High caliber realistic metrics • Although not a “reference model” we work with the same methodology successfully used by EDM and TMF Reference Model • The goal is to harmonize across three key areas: –Core RIM, –Terminology –Metrics
  20. 20. © 2017 PAREXEL INTERNATIONAL CORP. / 20 THANK YOU © 2017 PAREXEL INTERNATIONAL CORP. / 20

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