INTRODUCTION TO MPXR AND THE GLOBAL COMPLAINT HANDLING SYSTEM PLEASE SUBMIT QUESTIONS TO:

AND NOW… A WORD FROM (ONE OF) OUR SPONSORS

MPXR MOBILE PRODUCT EXPERIENCE REPORTING

 Web-based  Product Experience Reporting MPXR WHAT IS IT?

iPhone Laptop Android Phone iPad MPXR WHAT IS IT?

 Reduces paperwork  PIR (Product Information Report  PER (Product Event Report)  Eliminate / reduce follow-up  Improve accuracy  Deployed across multiple businesses MPXR WHY DO WE USE IT?

Average complaint entry takes 12 minutes Initiated on mobile device, finished on another device Multiple attachments ID any missing information Reports sent directly to GCH MPXR TOP FEATURES

DEMO MPXR

GLOBAL COMPLAINT HANDLING STAGES HIGH-LEVEL PROCESS OVERVIEW

GLOBAL COMPLAINT HANDLING STANDARDIZED PROCESS Complete Product Event Complete Complaint Resolved [ Complaint] Intake Communications Product Analysis Regulatory Reporting [Complaint] Intake Complaint Investigation Staging Record Response More Information required to Resolve the Complaint The Standardized complaint handling process is depicted in this graphic.

The complaint handling process always begins with the creation of a Staging Record. STAGING RECORD STANDARDIZED PROCESS Staging Record Staging Records are used to document a potential complaint.

INTAKE STANDARDIZED PROCESS Staging Record If it is determined that the event is not a complaint, the Staging Record is closed. closed Event is not Complaint

INTAKE STANDARDIZED PROCESS If it is determined that the event may be a complaint, the Intake process is completed. At this point in GCH, the record has been promoted and is now referred to as a Product Event. [ Complaint] Intake Staging Record

NEXT STEPS STANDARDIZED PROCESS If, based on the information available, it is determined that the event is a potential complaint, the next four process steps occur. [ Complaint] Intake Product Analysis Regulatory Reporting [Complaint] Intake Complaint Investigation Staging Record

COMMUNICATIONS STANDARDIZED PROCESS When more information is needed to make a decision in any of the remaining four steps, a request for more information is required. Staging Record[Complaint] Intake Product Analysis Regulatory Reporting Reportability Decision Complaint Investigation Communication s More Information required to Resolve the Complaint Response The information shared in the response is assessed and applied to the record.

COMPLETION STANDARDIZED PROCESS Once all of the information has been added to the record and enough information is available to close the event, the Event Status is changed to Closed and the complaint is resolved. Staging Record[Complaint] Intake Product Analysis Regulatory Reporting Reportability Decision Complaint Investigation Complete Product Event Complete Complaint Resolved

KEY TERMS GLOBAL COMPLAINT HANDLING Staging Record Staging Record Intake Regulatory Reporting Regulatory Reporting Product Analysis Product Analysis Reportabilit y Decisions Reportabilit y Decisions Complaint Investigatio n Complaint Investigatio n Communicatio n Communicatio n Used to document a potential complaint. Begins when the file is promoted to a Product Event and it has been determined that the event is a potential complaint. Conducted to evaluate and analyze the device related to the complaint. Determines what to report to the appropriate regulatory bodies. Determines if and how to report to the appropriate regulatory bodies. The results and conclusions of the investigation are documented to determine if a formal investigation is required. Used to ask for more information, receive responses, and provide information to others.

STAGING RECORD

PURPOSE The Staging Record is used to document a potential complaint. It is also used to document non- complaint information.

STAGING RECORD ROLE OF THE USER The role of the user is used to review the pre-populated information and determine if additional information is needed to:  Promote the Staging Record to a Product Event (potential complaint) or  Close the Staging Record (non-complaint)

STAGING RECORD DEMO

STAGING RECORD AUTOMATED PROCESS – PRE-POPULATED INFORMATION The standardized automated Staging Record process is depicted below. Source System Record Updates Is the record being addressed by the correct BU / Region? No Send Event to Correct BU/GEO Document Event Details Add or Verify Information (As Necessary) Does Another Record Exist ? Merge to Existing Record & Reassess Yes Promote the Staging Record to a Product Event Yes Is the Event a Potential Complaint ? No Document Rationale for why the Record is not a Complaint and change Status to Closed Yes

STAGING RECORD KEY FIELDS Country * Notified Date Brief Description Product Information * Attachments

GCH SYSTEM ORIENTATION We’ll review:  Key Stages and Commonalities:  The Home Page  PE Quick Info  Field Help Text  Drag and Drop Functionality  Quality Checks  Save and Save and Back  Icons and Hyperlinks Demo

BASIC NAVIGATION HOME PAGE The Overlay Tool Home Page is shown below. 1.Upper Navigation Hyperlinks: The navigation links to Home and Maintain are located at the top of the screen 2.Detailed / Saved Search 3.Work Inbox 4.Links / Templates

BASIC NAVIGATION HOME PAGE Quicklinks Bar: Create  Create new items such as an Account, Contact, Product, etc. Recent  View your 10 most recent tasks

FEATURES  There are three sections to a Staging Record – top, middle, and bottom.  You can drag and drop any tab to any section  There are no limits to how many tabs are in each section – you can even have zero in a section DRAG AND DROP Best Practice: Put the most used tabs at the top of the page to make it easier to see them most often.

STAGING RECORD KEY FIELDS

STAGING RECORD KEY FIELDS

INTAKE

PURPOSE Intake is primarily used to document complaints. Intake is not a specific task in GCH, rather, Intake is a process. The purpose of Intake is to add the balance of the information needed for further processing of the event.

INTAKE ROLE OF THE USER The role of the user it so document the event details, construct the narrative, code the event, and follow-up when required.

INTAKE DEMO

INTAKE PURPOSE Validate Entries Add Information to the Complaint Begin Complaint Documentation Document Key Data

EVENT INTAKE AND COMPLAINT DETERMINATION PROCESS The standardized Intake process is depicted in this graphic. Enter Event Details in System No Response Continue with Processing the Complaint No Review Product Event Are Additional Records Needed? Construct Narrative Code Event Is Follow-Up Required? Yes Communications Create Additional Records Yes

BASIC NAVIGATION Some features of PE Quick Info link are:  Follows every process throughout the transaction  Displays the fields that are important for that process  Will not be the same through each process area PRODUCT EVENT (PE) QUICK INFO

FEATURES Contextual Information Facilitates consistent usage To view the field help text: 1.Hover over the field 2.Click anywhere on the blue highlight 40 fields have additional contextual (e.g., Field Level Help) information. FIELD HELP TEXT 2 1

The layout of the Product Event page is updated as shown here. The main changes include: 1.Menu Items: List of standard transactions associated to the Product Event 1.Quick Access to transactions 2.Transaction List: Displays the associated transaction for each Menu Item 1.(20) indicates the PLI number 2.() Indicates the transaction is on the PE level LAYOUT LEFT NAVIGATION / MENU ITEMS 1 2

INTAKE KEY FIELDS Most of the information needed in the [Complaint] Intake can be found on the Product Event page. The tabs used for this purpose include: Product Line Items Clinical and Literature Text Info Dates Patient Information Partners Attachments

PERSONALIZATION An example of the Quality Check feature is shown here. 1.Quality checks indicated by ! in a Yellow triangle and ! in a Red circle. 2.The fields will be highlighted to indicate that they need to be addressed 3.Hover over the icons and you see the message ‘Missing Partner Name’, ‘Undetermined PLI’ or ‘Missing event Context’ QUALITY CHECKS 1 3 2

FEATURES ASKED BUT UNKNOWN FIELDS New check boxes for Asked but Unknown have been added for certain fields such as Patient Age, Patient Date of Birth, etc. If there is a value added in these fields and then we select the Asked but Unknown check box, the values are automatically erased. The system will generate an error if you save the transaction with a value in these fields and the Asked but Unknown checkbox selected. Asked but Unknown has also been added as an option in certain drop-down fields such as Patient Gender. These values now get tracked in the different reports. When you promote the SR to a PE, all the values get copied into the Event as well.

FEATURES There are two options for saving information in the Overlay Tool. 1.Save button: Allows you to save the information you have entered on a particular page and then remain on the same page. 2.Save and Back button: this button has been standardized on all transactions. It allows you to save the information on a page and return to the page that you were previously on. SAVE, SAVE AND BACK, AND BACK 2 1

INTAKE KEY FIELDS Product Line Item Details and Codes are located on the Product Line Items page. Let’s review the information required to process a [Complaint] Intake.

PRODUCT ANALYSIS

PURPOSE AND USER ROLE In Product Analysis, users document the receipt of the returned product and the results and conclusions of the analysis in GCH.

PRODUCT ANALYSIS DEMO

PRODUCT ANALYSIS PROCESS FOR PRODUCT ANALYSIS When the event is promoted to a complaint, and an analysis may be conducted on the product. The standardized Product Analysis process is depicted in this graphic. Log Product Receipt Product Analysis Required? Document the Rationale for no Analysis, Date, and the Individual who mad the decision No Disposition Product Yes Perform Analysis Additional Info? Record Completion Date & Individual who made the Decision Document Methods, Results, Outcomes Communications Reportability Decision Complaint Investigation Yes No Communication Returns Mgmt (Physical Product) Perform Decontamination New Information

PRODUCT ANALYSIS KEY FIELDS Only a few of the tabs needed in Product Analysis will be found on the Product Event page. All Schedule Actions PE Quick Info Left Navigation

PRODUCT ANALYSIS KEY FIELDS The majority of the tabs used in Product Analysis page are found on the Product Analysis page: Product Line Items Product Location PLI Codes All Attachments Analysis Details Text Info

COMPLAINT INVESTIGATION

PURPOSE AND USER ROLE Complaint Investigation is used document the results and conclusions of the investigation in GCH. When the decision has been made that the event is a complaint, an investigation transaction is created.

COMPLAINT INVESTIGATION DEMO

COMPLAINT INVESTIGATION PROCESS FOR COMPLAINT INVESTIGATION An investigation is conducted when the decision has been made that the event is a complaint. The standardized Complaint Investigation process is depicted in this graphic. Summarize Investigation and Populate Applicable Codes Review Event Details Yes Escalate Request for a New Formal Investigation, Document Reference No. & Date of Decision Document Rationale For No Investigation Investigation Required? Yes Conduct Investigation Is a New Formal Investigation Required ? No Document Rationale For No New Formal Investigation Continue with Processing the Complaint No

COMPLAINT INVESTIGATION SCREEN ORIENTATION To access the Investigations screen, click on the Investigations Menu item in the Left Navigation. The available Investigation transactions display. Click on the specific transaction to open the transaction page.

COMPLAINT INVESTIGATION SCREEN ORIENTATION The tabs that are accessed when working on an Investigation are: Investigation Details PLI Codes Product Line Items All Attachments All Text Info Formal Investigation

REPORTABILITY DECISIONS

REPORTABILITY DECISION PURPOSE Reportability Decisions are made about if the event is reportable and if it is, which report needs to be filed.

REPORTABILITY DECISION ROLE OF THE USER The role of the user is review the information in the Product Event to determine if the event is reportable. Once the decision is made, the rationale for the decision will also be documented.

REPORTABILITY DECISIONS DEMO

REPORTABILITY DECISION PROCESS FOR REPORTABILITY DECISION The standardized Reportability Decision process is depicted in this graphic. NOTE: Not all information may be available at the time of the decision. [Complaint] Intake Product Analysis Complaint Investigation Communications Identify Decision Type Determine Report Type & Timeline Confirm Aware Date Regulatory Reporting Document Rationale No More Information Needed ? Communications Yes Secondary Review (per Defined Criteria) Reportable based on Decision Tree? No Document Rationale Yes Secondary Review (per Defined Criteria) Information Received

REPORTABILITY DECISION KEY FIELDS To access the Reportability Decision screen, click on the Reportability Menu item in the Left Navigation. The available Reportability Decision transactions display. Click on the specific transaction to open the transaction page.

REPORTABILITY DECISION KEY FIELDS The tabs that are accessed when working on a Reportability Decision are: Rep. Decision Details Text Info Dates Decision Tree Associated Transactions

REGULATORY REPORTING

PURPOSE The purpose of Regulatory Reporting is to document the submission of a report to the applicable regulatory body / competent authority in GCH.

REGULATORY REPORTING ROLE OF THE USER The role of the user is to complete the appropriate regulatory report and document in GCH. Once complete, submit the report to the regulatory body / competent authority within the appropriate timeline.

REGULATORY REPORTING DEMO

REGULATORY REPORTING PROCESS FOR GENERATING A REGULATORY REPORT Reportability Decision Communications Yes Determine Due Date Yes The standardized Regulatory Reporting process is depicted in this graphic. Additional Reports Needed? No Submit Report Complete Translation (if applicable) More Information Needed? Populate Report Secondary Review per Defined Criteria No / Time Sensitive Information Received

REGULATORY REPORTING SCREEN ORIENTATION To access the Regulatory Reporting screen, click on the Regulatory Report menu item in the Left Navigation within the Product Event. The available Regulatory Report transactions display. Click on the specific transaction to open the transaction page.

REGULATORY REPORTING SCREEN ORIENTATION The tabs that are accessed when working on Regulatory Reporting are: Reg Report Details Dates MDR (e.g., Reg Report tab) Schedule Actions

COMMUNICATIONS

PURPOSE Communications can occur when more information is needed to assess the status of a potential complaint, clarify details, or to obtain more specifics about an event. Communications also are used to make others aware of the status of the complaint, potential complaint, or non- complaint.

COMMUNICATIONS DEMO

COMMUNICATIONS SCREEN ORIENTATION To create communication transactions, access the Product Event screen and click the All Schedule Actions button. The Actions dialogue box displays and the Communication Activity can be created. Access the Communications menu item, and click on the specific transaction to open the transaction page.

REGULATORY REPORTING SCREEN ORIENTATION The tabs that are accessed when working on Regulatory Reporting are: Reg Report Details Dates MDR (e.g., Reg Report tab) Schedule Actions

GLOBAL COMPLAINT HANDLING COMMUNICATIONS Complete Product Event Complete Complaint Resolved [ Complaint] Intake Communications Product Analysis Regulatory Reporting [Complaint] Intake Complaint Investigation Staging Record Response More Information required to Resolve the Complaint Communications transactions can occur at any point in the complaint handling process.

COMMUNICATIONS OUTPUT

GLOBAL COMPLAINT HANDLING LEARNING PLAN

LEARNING PLAN NEXT STEPS

QUESTIONS AND ANSWERS PLEASE SUBMIT QUESTIONS TO:

APPENDIX

HOW TO USE MPXR

MPXR HOME PAGE

MPXR NAVIGATION

Required Fields are marked by an asterisk and a red callout box. Date Fields are located throughout the application. Type in the year and select the other date components from the dropdowns. MPXR REQUIRED FIELDS Selecting “Today” populates the Year, Month, and Day fields with ‘today’s’ date.

MPXR CHECK BOXES, RADIO BUTTONS, AND DROP DOWNS Check Boxes Radio Buttons Drop Downs Are used for data entry. Select all that apply. Use Unknown if you don’t know or can’t get information.

COMPLETE INDICATORS Completed Sections are marked by a Green Check in the navigation pane. MPXR

PATIENT AND HCP INFORMATION Information can be pre-populated with a registered Serial Number. If the registered serial number is not available, the Product Information can be entered manually.

iPhone Laptop Android Phone iPad Photos MPXR ADDING ATTACHMENTS Laptop

MPXR PRINT AND SUBMIT Click Review /Submit to review the report and submit it. Print a copy of the report. Record the mPXR number (tablet / phone). Return the product in the return mailer kit – include the Packing Slip.

GLOBAL COMPLAINT HANDLING JOB AID REFERENCES

STAGING RECORD DEMONSTRATION Job Aid link:  Staging Records; Automated Staging Records; Automated

INTAKE DEMONSTRATION Job Aid link:  Intake Intake

PRODUCT ANALYSIS DEMONSTRATION Job Aid link:  Product Analysis; Manual Check In Product Analysis; Manual Check In  Product Analysis; Quick Check In Product Analysis; Quick Check In  Product Analysis; Documenting Results Product Analysis; Documenting Results

COMPLAINT INVESTIGATION DEMONSTRATION Job Aid link:  Investigations Investigations

REPORTABILITY DECISIONS DEMONSTRATION Job Aid link:  Reportability Decisions Reportability Decisions

REGULATORY REPORTING DEMONSTRATION Job Aid link:  Regulatory Reporting Regulatory Reporting  Regulatory Reporting; Non-Electronic Vigilance Form Regulatory Reporting; Non-Electronic Vigilance Form

COMMUNICATIONS DEMONSTRATION Job Aid DRAFT documents  Communication; Follow-up Communication; Follow-up  Communication; Customer Response Communication; Customer Response