IDMP update: A practical approach to IDMP implementation and the impact of the possible new phasing

Transcription

1 IDMP update: A practical approach to IDMP implementation and the impact of the possible new phasing Frits Stulp Managing Director Iperion Life Sciences Consultancy Samarind Webinar July 29th, 2015

2 CONTENTS Introduction A practical approach to IDMP implementation The building blocks: Understanding the impact and recognizing the data An example: Clinical particulars Bringing IT together (IT Architecture) Next steps and the impact of the possible revision in timing Questions

3 Frits Stulp INTRODUCTION

4 INTRODUCTION OF FRITS STULP M.Sc. In Pharmacochemistry Worked for Yamanouchi / Astellas ( ): Responsible for development and maintenance of R&D Quality System Manager of European SAP Competence Center / SAP Project Manager Worked for Accenture ( ): Project manager for several projects in Healthcare and Life Sciences (a.o. Business Intelligence projects, compliance projects) Independent project manager / advisor since 2011 as Mesa Arch Consulting: Specialized in project management of IT projects for Regulatory Compliance Project manager for XEVMPD compliance project for Astellas Lead consultant and Program Manager for IDMP compliance at Astellas IDMP SME and practical advisor to MAH s and Regulatory / PV software suppliers Active speaker on several IDMP conferences Managing Director of Iperion Life Sciences Consultancy: Specialized consulting in (regulatory) compliance in life sciences by applying IT tools (system-agnostic)

5 COMPANY PROFILE DEDICATION TO LIFE SCIENCES Pharma/Biotech Medical Devices Contractors Health Care SOLUTION PROVIDER Information Systems GxP Cloud Comp. Consultancy DELIVERY CHARACTERISTICS Reliable Solutions Project Results High Quality Customer Satisfaction

6 CONSULTANCY Regulatory Affairs (XEVMPD / IDMP) Quality Management Computer System Validation Services IT Compliance & Audits Consultancy services are based on content knowledge and not specific or limited to any system or tool

7 IDMP IDMP is mandatory Need to stay compliant to ensure products on the market First focus on the EU, but keep in mind the global perspective IDMP can bring additional benefits to the company Global identifiers allow for improved communication and understanding between regions and departments

8 A practical approach to IDMP Implementation: - the building blocks: Understanding the impact and recognizing the data An example: Clinical particulars Bringing IT together (IT Architecture)

9 IDMP

10 A DATA EXAMPLE Manufacturer, the related Operation type and associated Manufacturing Authorisation number Where do you record this in your RIMS, Production system, a list? Who is responsible RA, Manufacturing or QA?

11 ANOTHER DATA EXAMPLE Information on the included device with your product: Like its material and physical characteristics Where do you keep such data?

12 MAPPING THE IDMP DATA TO SOURCES Medicinal Product The product administered to a patient for treating or preventing disease Example data: Combined Pharmaceutical Dose Form Possible sources: Dossier, RIMS Manufacturer Information on the manufacturer of the product Example data: Manufacturing License Number Possible sources : RIMS, ERP, Manufacturing information systems, Dossier Marketing Authorization The registration and marketing of the product Example data: Marketing Date Possible sources : M&S affiliate, Dossier, RIMS Medicinal Product Packaged Medicinal Product The Packaging of the product Example data: Image of the packaged product Possible sources : RIMS, ERP, Artwork systems, Manufacturing information systems Clinical Particulars Pharmaceutical Product Manufacturer Marketing Authorization Packaged Medicinal Product

13 MAPPING THE IDMP DATA TO SOURCES Pharmaceutical Product Data regarding the manufactured item. Often equal to the Medicinal Product, but product can undergo transformation before being administered Example data: Strength of all ingredients Possible sources: Dossier, RIMS, ERP Clinical Particulars Information about indications, contra-indications, undesirable effects and interactions Example data: Intended Effect Possible sources : Dossier, RIMS, Product Information (Systems), SmPC, SPL, Drug safety systems Substances Supporting details of substances used Example data: Molecular weight Possible sources : Dossier, RIMS, ERP, SRS? Clinical Particulars Medicinal Product Manufacturer Pharmaceutical Product Marketing Authorization Packaged Medicinal Product

14 UNDERSTANDING IDMP IMPACT Finding the sources and the impact of IDMP on your environment: Find where this data is stored (system, paper, etc.) Determine specifics for products in scope (devices, biologicals, etc.) Determine consistency of this information across the globe Understand the processes & procedures that ensure this data is kept up to date: With the up to date regulatory information With the practice applied in the plant (a.o.) View the organizational impacts of IDMP In other words: Do a readiness assessment

15 TYPICAL AREAS OF YOUR ASSESSMENT (1/2) Regulatory scope Number of dossiers Legacy of National Products ectd vs pre-ectd Global or regional company Number of license partners and M&A s Medical devices in portfolio Biologicals on the market Current compliance XEVMPD compliant SPL compliant UDI prepared / compliant Supply chain and manufacturing scope Number of plants In-house vs contract Manufacturing

16 TYPICAL AREAS OF YOUR ASSESSMENT (2/2) Process maturity All processes described Process orientation vs functional (silo) orientation Procedural arrangements with third parties (e.g. Master data exchange) IT & architecture Infrastructure for master data mgt Integration level for applications, like Enterprise service bus and datawarehousing ERP policy (single instance vs multiple) Gateway management in place Labelling solution in place Organizational readiness Coverage and detail level of procedures Establish impact on current roles Change readiness of involved functions

17 WHAT DRIVES THE OUTCOME? Some key-factors can be recognized that strongly drive the complexity of your IDMP challenge, for example: Decreases complexity Increases complexity The outcomes allow you to make your plan and set priorities, naturally, aligned with exernal deadlines and phases.

18 A practical approach to IDMP Implementation: - the building blocks: Understanding the impact and recognizing the data An example: Clinical particulars Bringing IT together (IT Architecture)

19 AN EXAMPLE Clinical particulars: Typically coming from the Product Information documents like the Summary of Product Characteristics MedDRA coding is needed when submitting the IDMP records Although identified in the new phasing as Iteration 3, this information can have major impact on patient safety and label consistency Let s have a look at some of the fields and where to find them Then we will see how we can manage this in the SPC and the IDMP submission at the same time..

20 CLINICAL PARTICULARS

21 IDMP Clinical Particulars: high level

22 IDMP Clinical Particulars: Example

23 IDMP Clinical Particulars: Example

24 IDMP Clinical Particulars: Example Coded in MedDRA

25 PI STRUCTURED AUTHORING Instance text QRD template Master text

26 PI STRUCTURED AUTHORING Getting the clinical particulars directly from the SPC 2. Assign Code, via code list 1. Select Clinical Particular(s) Then clinical particulars can be delivered as part of the IDMP submission

27 A practical approach to IDMP Implementation: - the building blocks: Understanding the impact and recognizing the data An example: Clinical particulars Bringing IT together (IT Architecture)

28 OPTIONS FOR IDMP ARCHITECTURE

29 IT ARCHITECTURE Dependent on where your IDMP data is, you can design your IT architecture, like: Expand your IDMP data in your RIMS and/or Manage your source documents (like SPCs) Bring the data together from the sources Ensure common terms (= Master data mgt) And then allow for approval, XML/SPL creation and submission This can be achieved in all 4 scenarios

30 NEXT STEPS AND THE IMPACT OF POSSIBLE REVISION IN TIMING

31 HIGH LEVEL FEEDBACK FROM EMA INFORMATION DAY The official implementation date of 1 July 2016 for the full IDMP scope is recognized as nearly impossible to achieve A phased approach to implementation is proposed in which: Phase 1: limited scope (XEVMPD, substances, mandatory items to create IDMP identifiers) Phase 2: scope extended with Investigational Medicinal Products (development products) Phase 3: include Clinical Particular details Phase 4: include batch identifiers, alignment serialization and other remaining IDMP items Phase 5: include veterinary products With initial timelines proposed for late 2017 and later phased up to 2019

32 ANALYSIS OF ITERATIONS

33 Iteration 4 Iteration 3 Iteration 1 Iteration 4

34 Iteration 2

35 IMPID HIGH LEVEL DATA MODEL

36 NEXT STEPS So, the EU ISO IDMP Taskforce has formulated a phasing plan that: Is more realistic Has buy-in from key stakeholders EMA, NCA s, Industry, Standardization organizations But requires approval of the European Commission.. In other words: Be prepared to adjust your IDMP plans to a longer term phasing that fits into your other RA IT plans Make sure you can reach this timeline

37 CLOSING IDMP is a complicated area and although phasing is being discussed at this time, you will still need to organize yourself to deal with this by: Understanding your IDMP Readiness Incorporating Business and IT alignment in your project Plan the required project activities, taking relevant phasing and internal developments into account Stay tuned to the possible change of timing and take ownership of your IDMP compliance There are accelerators out there to help you like: Project experience, Program templates, Process insights Let me know if you have any questions!

38 Contact: Frits Stulp Managing Director Consultancy Iperion Life Sciences Consultancy Phone: +31(0) Website: LinkedIn: