Process and Architecture Overview IDMP Identification of Medicinal Products. Sven Eller, Life Sciences Solution Engagement Manager

Process and Architecture Overview IDMP Identification of Medicinal Products Sven Eller, Life Sciences Solution Engagement Manager

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SAP s History Managing Global Regulations Operational Compliance Compliant Manufacturing (GMP) Good Lab Practices (GLP) HCP Spend (Sunshine Act) Serialization (GTIN/GLN) Regulatory In-take Global Trade Compliance Denied Parties Import/ Export Documentation Customs Duty Regulatory Policy Track & Trace GxP Submission of Drug Master Data Comply with Regulations Regulatory Submission ectd submission (through Partner: Lorenz Life Sciences) UDI and IDMP Environmental Compliance Waste Management Hazardous Material Occupational Health and Safety Emissions Management REACH Control Execution Financial Compliance SOX FCPA FASB, SEC (Dodd Frank) 2016 SAP SE or an SAP affiliate company. All rights reserved. 3

IDMP Iterations Iteration 1: Already marketed drugs (See content in Article 57) Support life cycle management of MPIDs, PCIDs, PhPIDs Iteration 2: Investigational Medicinal Products Additional data elements and ISO Norm 11615 Iteration 3: Clinical Particulars Iteration 4: Batch Identifiers Remaining ISO norm content (ISO 11615 & ISO 20443) Iteration 5: Veterinary products 2015 SAP SE or an SAP affiliate company. All rights reserved. 5

Anticipated Scope & Timeline for IDMP/SPOR* Based on meeting minutes of IDMP taskforce meeting Feb 2016** Note: Timeline depends on publication date of EMA Guidelines +12 +6 July 2016 Q1/Q2 2017 Q1/Q2 2018 Q3/Q4 2018 Expected Release of the EU Implementation Guideline Enforcement of Iteration 1 Law states: Implementation is July 2016 redefinition: Start of transition phase *SPOR = Substance, Products, Organisations, Referentials 1st submission: Product and Substance Iteration 1 ** Task Force MM only address Iteration 1, not the following Iteration 2. It is uncertain, when EMA will publish the timeline officially on their webpage 2015 SAP SE or an SAP affiliate company. All rights reserved. 6

Countries participating in IDMP standard definition FDA and EMA have decided to implement ISO IDMP regulations Source: Andrew Marr, EMA IDMP presentation 2016 SAP SE or an SAP affiliate company. All rights reserved. 7

Outlook Phased SAP Approach Step 1 Master Data Hub and Enterprise Data Model (Customer Co-Innovation has started) Step 2 Text Analysis for Regulatory Documents (Customers invited to PoC) Step 3 Message Creation and Submission (Timeline depending on EMA Implementation Guideline Availability) 2016 SAP SE or an SAP affiliate company. All rights reserved. 8

Architecture Details actions Workflow & Approvals Reporting SAP HANA for IDMP Enterprise-wide Master Data Hub Reg. Reg. Agency Agency Reg. Agency Non- SAP Systems* SAP Non-SAP** File Upload Consolidated Data Data Replication Consistency Rules IDMP Message structure & Message Content Direct via on-premise gateway (SAP or RIMS provider) or as future consideration via SAP Pharma Network in the Cloud Owners content *SAP ERP, EHS, MDG, ** CTMS, RIMS, GInAS, MDM, Controlled Vocabularies (Catalogs) Message structure definition (IDMP, UDI, ATTP, GS1, ) Staging and data cleansing Detection of inconsistencies Reporting on data content and quality Creating and approving submission content Built in extensibility concept for future requirements 2016 SAP SE or an SAP affiliate company. All rights reserved. 11

IDMP Processes External Stakeholders Data from CMOs 5 Regulatory Agencies Regulatory Affairs UI 2 Integrate external information Data enrichment, address cleansing, duplicate check, Consistency check rules Regulatory Collaboration (Corporate / Local Reg Affairs) Adaptable workflow Auditable change process 8 Maintain Consolidate 4 Validate/ Cleanse 6 Inform Manage Change 9 Approve Submit 10 1 3 Internal systems / Responsibility Matrix Local maintenance of IDMP relevant data in designated systems Information captured in Documents Work flow 7 Internal Stakeholders (R&D, Med.Affairs, PV, Manufacturing, Marketing, ) 2016 SAP SE or an SAP affiliate company. All rights reserved. 13

Any middleware (optional) Any middleware (optional) SAP Solution Offerings For Pharma Track And Trace ATTP: Manage Serialization Within Company / Pharma Network: Exchange Serialization Externally Government Any middleware 1 connection Pharma Network Cloud Open Q1 to Early Adopters ERP/ WM SAP Advanced Track and Trace for Pharmaceuticals On SAP HANA Cloud Platform 3PLs, CMOs wholesalers 100s of 1:1 connections available Early Adopter Model Any middleware (optional) Application interface framework (AIF restricted license included in SAP Advanced Track and Trace for Pharmaceuticals) Pack line/device AIF content shipped for regulatory reporting and CMO/wholesaler messaging 2016 SAP SE or an SAP affiliate company. All rights reserved. 15

Pharma Network Preview of Planned IDMP Functionality Key Collaboration Scenarios CMO Discussion 1: CMO Scenario Serial Number Request and Response CMO Commissioned IDs & Aggregations IDMP Information (Documents, WebUI Front-End, Messages) Pharma MAH Regulatory Reporting Messages 4: International Regulatory Reporting Scenario Authorities 3PL Commissioned IDs & Aggregations 2: 3PL Scenario Verification request & response for sellable returns Commissioned IDs & Aggregations according DSCSA CMO = Contract Manufacturing Organization 3PL = Third Party Logistic Provider MAH = Market Authorization Holder 3: US Supply Chain Scenario US Wholesaler Commissioned IDs & Aggregations according DSCSA 3: US Supply Chain Scenario US Hospitals Pharmacies SAP Advanced Track and Trace for Pharmaceuticals SAP IDMP Application Pharma Network (cloud) *simplified view 2016 SAP SE or an SAP affiliate company. All rights reserved. 16

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