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Hans van Bruggen | Semantic interoperability to manage medicinal data and exchange IDMP messages with different regions


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Hans van Bruggen | Semantic interoperability to manage medicinal data and exchange IDMP messages with different regions

  1. 1. Managing and exchange of medicinal data within and across companies and regions Hans van Bruggen
  2. 2. Agenda • Objective of pharmaceutical medicine • Why manage medicinal data? • Within industry • Within agencies • Between industry and agencies • Examples of what can go wrong • What are the challenges? • Summary September 2016 ©eCTDconsultancy 2
  3. 3. Objective of pharmaceutical medicine Concerns the development and maintenance of: • consistently produced • high-quality drugs with a • favorable efficacy-safety profile • to clearly defined patient population • when used according to the Product Information September 2016 ©eCTDconsultancy 3
  4. 4. Why manage medicinal data within industry? • Marketing sees a market for a therapy in target patient population • Pharmaceutical development produces the high-quality product • Clinical development tests therapy in target patient population • Production produces the high-quality product in a consistent manner • Regulatory Affairs registers that product in the patient population tested, by proving a favourable efficacy-safety profile • Global supply chain ensures continued supply to the markets • Pharmacovigilance monitors adverse events in relation to a product, considering its quality and usage by patients September 2016 ©eCTDconsultancy 4
  5. 5. Why manage medicinal data within agencies? • Ensure healthy volunteers are not at risk when exposed to new medicines • Ensure patients receive the best therapy (efficacy-safety) • Ensure manufactures consistently produce high-quality drugs • Ensure clinical trials are predictive for the marketed situation (patient and product information) • Ensure adverse events are collected, analysed and evaluated adequately (efficacy-safety)  CAPAs September 2016 ©eCTDconsultancy 5
  6. 6. Why manage medicinal data between industry and agencies? • Shared responsibility to safeguard the patient September 2016 ©eCTDconsultancy 6
  7. 7. Examples • Vioxx • Thyrax • Mediator • Heparin • Drug shortages • Uiterlijk twee maanden voor de (tijdelijke) onderbreking van levering van het geneesmiddel, moeten handelsvergunninghouders dit melden aan het CBG. Zij moeten deze melding doen via het e-mailadres: GMP-GCP@cbg- September 2016 ©eCTDconsultancy 7
  8. 8. Vioxx Adverse events not adequately evaluated • Used by >80 Milion people  resulting 88,000 - 140,000 cases of serious heart disease adverse events • 4-fold increase in heart attacks compared to naproxen (0.4% vs 0.1%) • Product withdrawn by Merck&Co./MSD in 2004 • No further risks • But also no further benefits!!!!!!!! • What if patients with risk factors would have been excluded???? • Advisory boards in US and Canada voted for return in 2005 • Merck has not returned Vioxx on the market (yet) September 2016 ©eCTDconsultancy 8
  9. 9. Thyrax Different dissolution rate per package • Increase in adverse event rates for blister (new) September 2016 ©eCTDconsultancy 9
  10. 10. Heparin major recalls due to contamination of active substance • Heparin active substance is derived from pig intestines • In 2008 FDA investigated >80 deaths related to heparin use • Heparin products from multiple companies • FDA found serious deficiencies at Baxter’s Chinese heparin supplier • Could be traced back to contamination of active substance from SPL batches processed in China September 2016 ©eCTDconsultancy 10
  11. 11. Mediator • In 33 years used by about 5M French patients • Intended use: diabetics • Off-label use: losing weight • About 2000 people died and many more hospitalised • Withdrawn from the market in 2009 September 2016 ©eCTDconsultancy 11
  12. 12. Drug shortages September 2016 ©eCTDconsultancy 12
  13. 13. How to solve the challenges?
  14. 14. What are the challenges? • What product? • e.g. product in bottles or blisters; what bottles, what blisters • e.g. product from different sources; which manufacturer site; which batch • What patient population? • e.g. with or without risk factors (disease status, comorbidity or comedication) • e.g. for the intended indication or for off-label use • How dependent are users from a single producer/supplier? • e.g. drug shortages 4-fold increase of the past few years • Ability to take corrective- or preventive actions when needed? • Within a company • Across companies by agencies September 2016 ©eCTDconsultancy 14
  15. 15. How to solve the challenges? • Integrate systems between • Industry • Agencies • Regulatory bodies • Inspectorates • Health care professionals • Move from unstructured data to structured data • Define a single source of truth • Apply semantic interoperability • ISO-IDMP (IDentification of Medicinal Products) September 2016 ©eCTDconsultancy 15
  16. 16. IDMP ©eCTDconsultancy 16
  17. 17. Medicinal Product (Per registered product) MPID Combined pharmaceutical dosage form IMPID cross reference Additional monitoring indicator Orphan Designation Authorisation Status Name medicinal product Invented name part Scientific Name Part Strength Name Part Pharmaceutical Dose Form Part Formulation part Intended use part Target Population Part Container or pack part Device part Trademark or Company Name Part Time / Period Part Flavour part Delimiter part Country where MP name is applicable Language where the IMP is applicable Classification System ATC Classification System Value ATC Classification System Legal basis of approval Classification System Value Legal basis of approval Classification System Medicinal product type Classification System Value Medicinal product type Classification System Peadiatric use Classification System Value Peadiatric use Classification System Authorised dose form Classification System Value Authorised dose form Classification System Falsified medicine flag Classification System Value Falsified medicine flag MPID Version Date MPID Version Identifier Document type Document identifier Regulated document attachment Document effective dateSeptember 2016 ©eCTDconsultancy 17
  18. 18. Authorization and Organization Marketing Authorisation Number Country where marketing authorization number is applicable Legal Status of Supply Marketing Authorisation Status Marketing Authorisation Status Date MA Procedure Identifier / Number MA Procedure Type Country where MP is marketed Jurisdiction marketing status Marketing Date Start Marketing Date Stop Risk of shortage supply Risk of shortage supply comment Name MAH MAH address Location address for MAH Location role for MAH Identifier for other MAH location September 2016 ©eCTDconsultancy 18
  19. 19. Packaging and devices PCID Package Description Package Item (Container) Type Package Item (Container) Quantity Package item (container) material Package component Material Package component type Device Type Device Trade Name Manufactured Dose Form Manufactured item unit of presentation Manufactured Item Quantity To be repeated for every container, material and device September 2016 ©eCTDconsultancy 19
  20. 20. Ingredient Role API Ingredient Role Excipient Substance Substance Strength Range (Concentration) Substance Strength Range (Presentation) Specified Substance Reference Substance Specified Substance Reference Specified Substance Specified Substance Reference Strength Range Ingredients To be repeated for every ingredient in the product September 2016 ©eCTDconsultancy 20
  21. 21. Clinical particulars and administration items Indication text Indication as disease/symptom/procedure Co-morbidity for Indication Administrable Dose Form Unit of Presentation Route of Administration PhPID Identifier Sets To be repeated for every indication To be repeated for every dose form and route of administration September 2016 ©eCTDconsultancy 21
  22. 22. Other iterations • Another 300 attributes! September 2016 ©eCTDconsultancy 22
  23. 23. Reducing health care costs and improving health? September 2016 ©eCTDconsultancy 23 Connecting • batch number register • ePrescription • eHealth record Improves impact analyses Improves signal detection Expedites corrective actions • Safety • Efficacy • Drug availability IDMP Falsified medicine MD UDI ePre- scription eHealth Records ICSRs eSubmis sions
  24. 24. Content vs Context - carrot and potato recipes September 2016 ©eCTDconsultancy 24 Manufacturers Competent authoritiesDrug products Production process (active) substances Clinical studies
  25. 25. Standalone documents capturing content September 2016 ©eCTDconsultancy 25 Manufacturers Competent authoritiesDrug products Production process (active) substances
  26. 26. Content in Context of ………… September 2016 ©eCTDconsultancy 26 Manufacturers Competent authoritiesDrug products Production proces (active) substances If you are not the intended recipient of this disk, you are hereby notified that any disclosure, copying, distribution or reliance upon the contents of this disk is strictly prohibited eCTD on <INN> Sequence <…..> Disk <x> of <n> <Application Number> <Type of submission> Marketing Authorisation Number(s): <Company logo> Applicant: Product Name: Date Sent: For technical issues contact <………@................................>
  27. 27. Different levels of interoperability ©eCTDconsultancy Organizational Interoperability Semantic Interoperability Technical Interoperability Standards Terminology Meaning Languages Laws Policies Cooperation agreements Workflows Transport protocols Data security Data accessibility Services and messages Data accessibility Data integrity Too often forgotten September 2016 27
  28. 28. Semantic Hub Industry content and context management tools Content (as data or in documents) Intrinsic metadata • Applied upon entry or sharing • Regenerate by reading the content Context Extrinsic metadata • Applied upon planning, submission, agency feedback • Regenerate by checking “where used” and other relationships September 2016 ©eCTDconsultancy 28 eDMS eSubmission tool RIM / MDM eCTD US eCTD EU IDMP US IDMP EU ERPQMS Status reports Search results
  29. 29. Summary • Integrate systems and exchange standards between • Industry • Technical interoperability • Semantic interoperability • Define a single source of truth • Agencies • Regulatory bodies during the various stages of a product lifecycle • Inspectorates • Health care professionals • eHealth records • ePrescription • Move from unstructured data to structured data • Apply attributes at the right level (separate content from context) September 2016 ©eCTDconsultancy 29
  30. 30. Thank you! Hans van Bruggen hbruggen(at)