IDMP: International Data, Multiple Processes

Transcription

1 IDMP: International Data, Multiple Processes Joel Finkle Director, Regulatory Innovation and IDMP Strategy

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to DIA, its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. DIA and the DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Not to be taken internally.

3 Overview Orientation Obligation Obstacles Opportunity Ovation

4 Orientation Viewpoint of Industry (and vendors) Differences from Agency vantage point What IDMP Means to MAHs/Sponsors Beyond Europe

5 Orientation: Viewpoint of Industry (and vendors) IDMP is an added cost But It could have benefits We ll farm it out just like we did XEVMPD Then you won t get those benefits We re already there Maybe but until the EMA implementation guide is done, you won t know for sure We re already doing MDM we ve got six of em Just no.

6 Orientation: Differences from Agency Vantage Point Both sides want to standardize how data is used: Master Data Management Agencies standardize across companies and other agencies: Horizontal Integration Companies standardize across processes: Vertical Integration Research Knowledge Registration Registration Registration Registration Registratio Knowledge Knowledge Knowledge Knowledge Knowledg Marketing and Supply Chain Knowledge

7 Orientation: What IDMP Means to MAHs/Sponsors Continuation of Article 57 Expansion of XEVMPD requirements Submission of the same record type for other things too Supply chain protection, minor variations, clinical trial registration, etc. Expectation that someday, it ll be used by other agencies too Recent survey by IRISS shows about 50% of companies are not positive about investment

8 Orientation: Beyond Europe IDMP is merely more SPL UDI is really a lighter IDMP for Medical Devices FDA now Netherlands starting July 2018 Rest of Europe depending on device type Drug Listings FDA Establishment Registration FDA REMS FDA Content of Labeling FDA Unfortunately not convergence: SPL is pretty generic in its capabilities, which depends heavily on vocabularies

9 Obligation Conversion from XEVMPD New and Changed Registrations Clinical Trials Supply Chain Security

10 Obligation: Conversion from XEVMPD Big initial effort to comply At first glance, maybe only twice the data But Single records for a product need to be broken up by package It s unclear yet whether all layers of packaging are needed (goal is to minimize, but then it s hard to represent kits)

11 Conversion (continued) EMA wants to help by pre-converting, but How to align with multiple product records on sponsor side? How to resolve differences of opinion on coding? Agency View 30 count blisters IDMP ID Sponsor View 3 blisters of 10 RIM ID PBJ11141 XEVMPD ID count blisters IDMP ID XEVMPD ID blisters of 5 RIM ID PBJ count Bottle IDMP ID Bottle of 100 RIM ID PBJ11143

12 Obligation: New and Changed Registrations Shouldn t be significantly more effort than current variations for Article 57 compliance Leverage business knowledge when managing product registrations Option Initial Cost Ongoing Cost Business Knowledge Value Use EMA Web tool $ $$$ $ Integrate with RIM $$$ $ $$$ Outsourced Service $$ $$ $$

13 Obligation: Clinical Trials XEVMPD currently is required for Investigational Products prior to registering a clinical trial Iteration 1 of IDMP doesn t cover Investigational Products Initially, still need XEVMPD! Eventually, some subset of the IDMP record will be needed prior to trial registration

14 Obligation: Supply Chain Security FMD = Falsified Medicines Directive Trace Counterfeit and Contaminated products Packages tracked at wholesale and retail level Minimal effort: Just register your IDMP IDs At least that s the theory EMA says that FMD should be able to use the Product database

15 Obstacles International Enthusiasm Gap European Loss of Momentum Moving Targets Volume of Data to be Tabulated

16 Obstacles: International Enthusiasm Gap So far, only EMA has made any progress toward implementation US says, We re already compatible Detail and magnitude very different Other proposals, such as CMC/PQ, do not leverage much of IDMP (yet) The US NDC is essentially a Medicinal Product ID (MPID) No other commitments yet

17 Obstacles: European Loss of Momentum Previous goals will not be met Implementation guide will not be available in 2018 Submissions will not be requested in 2019 Reasons Detailed, multi-phase project Relocation of EMA due to Brexit No expectation of cancellation

18 Obstacles: Moving Targets ISO IDMP standards continuing to evolve Mostly refinements for Substances Catching up to EMA requirements To be published very shortly EMA requirements not complete yet Good news: EMA is taking cost/benefit to industry as part of the process for setting requirements

19 Obstacles: Volume of Data to be Tabulated Global Substance Registration System ISO Full IDMP FDA CMC FDA DLER EMA IDMP Iteration 1 EMA XEVPRM

20 Obstacles: Volume of Data (continued) Most data locked up in documents Innovations in Natural Language Processes Innovations in Structured Documents Upgrade from XEVPRM not straightforward Turning one record into many (mainly packages) Re-coding of data where there are more values

21 Opportunity Justification to get RIM in order Master Data Management Structured Documents Reduced effort for variations/supplements

22 Opportunity: Justification to get RIM in order Label Management Correspondence Submission Tracking RIM Registration Tracking Commitments

23 RIM (continued) More than just IDMP Answer Management Questions Where am I marketed? When do I need to renew? What manufacturers are involved? What are the sources of ingredients? Are some packages only approved in some markets?

24 RIM Mapping product info toward IDMP 1) Medicinal Product Section/Field XEVMPD Yes/No/Partial Mapping MPID N Registration Number Combined Pharmaceutical Dose Form P Dose Form describing all pieces as sold (I)MPID Cross-Reference N Previous IDMP Registrations Reference Product Type N Previous IDMP Registrations Additional Monitoring Indicator Y Labeling Paediatric Use Indicator Y Labeling Orphan Designation Status Y Approval Letter

25 2) Name Section/Field XEVMPD Yes/No/Partial Full Name Y Name as authorised Mapping Invented Name Part P Extract from full name Scientific Name Part Y In XEVMPD, or extract Strength Name Part Y In XEVMPD, or extract Pharmaceutical Dose Form Part Y In XEVMPD, or extract Formulation Part P Extract from full name Intended Use Part P Extract from full name Target Population Part P Extract from full name Container or Pack Part P Extract from full name Device Part P Extract from full name Trademark or Company Name Part Y In XEVMPD, or extract Time/Period Part P Extract from full name Flavour Part P Extract from full name Delimiter Part N N/A (Medicinal Product Name) Country N Each name per country/language (Medicinal Product Name) Language N Each name per country/language

26 3) Classifications Section/Field Industry Position after Workshop (Product Classification) Value for ATC Code Accepted In XEVMPD Mapping (Product Classification) Value for Legal Basis of Approval Accepted From Approval Letter (Product Classification) Value for Medicinal Product Type Accepted In XEVMPD (Product Classification) Value for Falsified Medicines Flag Accepted New (Product Classification) Value for Authorised Dosage Form For discussion From Approval Letter (Product Classification) Value for EURD Identifier Acceptable From Application Form (Product Classification) Value for Biological/Vaccines flag Acceptable From Application Form

27 4) Header/Documents Section/Field XEVMPD Yes/No/Partial (Header) Identifier N From Approval Letter (Header) Effective Date N From Approval Letter Mapping (Header) Language N From EDMS for Document (Header) Version Number N From EDMS for Document (Header) Version Set Identifier N From EDMS for Document (Attached Document) Identifier N From EDMS for Document (Attached Document) Effective Date N From EDMS for Document (Attached Document) Type N From EDMS for Document (Attached Document) Content Y From EDMS for Document (Attached Document) Language Y From EDMS for Document (Attached Document) Media Type Y From EDMS for Document (Attached Document) Version Number Y From EDMS for Document (Attached Document) Version Set Identifier N From EDMS for Document (Master File) File Type Y From EDMS for Document (Master File) File Code Y From EDMS for Document

28 5) Authorisation Section/Field XEVMPD Yes/No/Partial Marketing Authorisation Number Y From Approval Letter (Marketing Authorisation) Country Y From Approval Letter Legal Status of Supply N From Approval Letter Authorisation Status Y From Approval Letter Authorisation Status Date P From Approval Letter Date of First Authorisation N Approval Letter / RIM International Birth Date N Approval Letter / RIM (Jurisdictional Marketing Authorisation) Country N From Approval Letter (Jurisdictional Marketing Authorisation) Marketing Authorisation Number N From Approval Letter Procedure Identifier/Number Y From Application Form Procedure Type Y From Application Form (Marketing Status) Country N From Application Form Marketing Status N Approval Letter / RIM Marketing Start Date N RIM Marketing Stop Date N RIM Risk of shortage supply N RIM / Supply Chain Risk of shortage supply comment N RIM / Supply Chain Later: PSURs, Marketing Events/Suspensions Mapping

29 6) Organisations / Manufacturers Section/Field Organisation (e.g. MAH, QPPV, PSMFL) XEVMPD Yes/No/Partial ARIM Identifier Y From OMS or DUNS Role N From OMS or RIM Location Address Y From OMS or RIM Location Role Y From OMS or RIM Entity Identifier (according to Role e.g. PSMF ID) Y From OMS or RIM Manufacturer/Establishment Operation Type N From OMS or RIM Manufacturing Authorisation Reference Number N From OMS or RIM Effective Date N From RIM Confidentiality Indicator N From RIM Later: SME Status

30 7) Packaging Section/Field XEVMPD Yes/No/Partial Mapping PCID N From IDMP SPOR System Package Description P From XEVMPD, but must be divided Package Item (Container) Type N From RIM or Documents Package Item (Container) Quantity N From RIM or Documents Material N From RIM or Documents Component Type N From RIM or Documents Component Material N From RIM or Documents Manufactured Dose Form N Form of the component. Easy things easy, hard things hard Unit of Presentation N From RIM or Documents Manufactured Item Quantity N From RIM or Documents Device Type N From RIM or Documents Device Trade Name N From RIM or Documents (Data Carrier Identifier) Code System N From RIM or Documents (Data Carrier Identifier) Value N From RIM or Documents Later: Characteristics of package, device, manufactured item; shelf life/storage

31 8) Pharmaceutical Product & Ingredients Pharmaceutical Product Administrable Dose Form Section/Field XEVMPD Yes/No/Partial Y Mapping Combined form, ignoring parts Solution for Injection Unit of Presentation N From RIM or Documents Route of Administration Y From XEVMPD PhPID Identifier Sets N Requires formula to be published Device Type Y Rare item Device Trade Name N Rare item Ingredient Ingredient Role P From RIM or Documents Substance P From RIM or Documents Strength Range (for Substances) P From RIM or Documents Specified Substance N From RIM or Documents Strength Range (for Specified Substances) N From RIM or Documents Confidentiality Indicator N From RIM or Documents Reference Substance P From RIM or Documents Reference Specified Substance N From RIM or Documents Reference Strength Range P From RIM or Documents Later: Pharmaceutical Product Characteristics, Device details (rare)

32 9) Clinical Particulars (Just Indications for now) Section/Field XEVMPD Yes/No/Partial Mapping Indication Text N MedDRA Mapping, one may become many Indication as "Disease/ Symptom/ Procedure" Y From XEVMPD Co-Morbidity N From Label Intended Effect N From Label Age Range Low N From Label Age Range High N From Label Later: Indications: gender, race and health status; other therapies Contraindications: same complexity as Indications Interactions Undesirable Effects

33 Opportunity: Master Data Management CTMS Content Management Safety Reporting QMS RIM Marketing Catalog External Vocabularies Supply Chain Partners

34 MDM (Continued) A product-centered database is useful for the entire enterprise Regulatory Marketing Supply Chain Safety Over the long term, efficiencies outweigh costs

35 Opportunity: Data-Structured Documents Data and Metadata currently embedded in documents Expose that data to other systems Non-Trivial Effort But not doing it is a slow, ongoing cost Examples IRISS DOCX Project to embed XML DITA Don t wait for standards, forge them! When you've been in marketing as long as I have, you'll know that before any new product can be developed it has to be properly researched. We ve got to find out what people want from fire, how they relate to it, what sort of image it has for them. Stick it up your nose Which is precisely the sort of thing we need to know. Do people want fire that can be fitted nasally? From The Hitchhiker s Guide to the Galaxy

36 Structured Documents (continued) Alternative is Natural Language Processing Most tools are very expensive Documents will only be analyzed once At least hopefully Revisions should be directly added to the RIM environment Still requires human review Instead, tag as you go Tools are young Requires some training for authors/reviewers But at least they re part of the existing word processing environment

37 Opportunity: Reduced effort for variations/supplements? EMA proposal Minor variations could be coded as just IDMP Submit without documents, just facts Initially small number of variation types Each additional variation type may require more data to be coded FDA CMC/Product Quality data is similar in concept, but different in data required

38 Ovation Improved processes at home Ease of exchange with partners and acquisition EMA requirements form the core of what will be needed elsewhere The prize for a job well done is

39 Ovation: Improved processes at home RIM Database: Know Thyself Smarter Authoring: Write it once Master Data Management: Know it once Technology investments have a cost, but should pay off in the long run, in ways outside the original purpose

40 Ovation: Ease of exchange with partners and acquisition Product acquisitions, out-licensing and co-marketing Already know your product information better Exchange registration and formulation data using standard formats

41 Ovation: EMA requirements form the core of what will be needed elsewhere US still promises that IDMP is in their future Other countries express interest Regardless of whether IDMP is implemented RIM database for registrations helps manage submission information Even with changes from market to market, commonalities make it worth centralizing knowledge Aim high in steering lesson from high school driving class

42 Ovation: The prize for a job well done is another job IDMP Iteration 1 is not the end Full IDMP is about 3X the data needed initially Use Master Data Management concepts to Integrate partner data Align marketing catalog with registrations Consolidate affiliate data

43 Ask Ask Questions

44 Image Credits All images Creative Commons Orientation: Luis Pérez Obligation: Erich Ferdinand Opportunity: Lachlan Donald Obstacles: Stevan Sheets Ovation: きうこ Kiuko