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RAD Overview

RAD Overview. R egulatory A ffairs D omain. Overview. RAD Purpose & Benefits Common RAD Definitions System Components Connection between System Components Differences from Old System. RAD Purpose & Benefits Purpose.

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RAD Overview

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  1. RAD Overview Regulatory Affairs Domain

  2. Overview • RAD Purpose & Benefits • Common RAD Definitions • System Components • Connection between System Components • Differences from Old System

  3. RAD Purpose & Benefits Purpose • A collaborative environment to develop global regulatory plans and submission documents that result from those plans • A controlled electronic environment to create and edit regulatory submissions • One Medtronic global regulatory tracking system that allows regulatory staff to easily find information about global submissions & approvals • Intended to replace existing local databases and tracking spreadsheets • Provides a platform to add complete tracking of approved drug products at a later phase • Efficient publishing of both paper and electronic submission

  4. RAD Purpose & Benefits Purpose • RAD replaced previous solution that utilized Desktop Client & EZ Subs • Previous system was not robust enough to support evolving global requirements • Previous system made heavy use of Virtual Documents and foldering to model and maintain Submission Geography-Product relationships

  5. 1. RAD Purpose & Benefits • 21 CFR 11 compliant electronic archive for regulatory files • A more efficient way to make submission documents available to the geographies • Creation of electronic submissions (eCTD) and more efficient creation of paper • Reports allow efficient tracking of regulatory metrics • Global visibility and reporting for submission, correspondence & approval data across Medtronic

  6. Common RAD DefinitionsIntroduction • RAD introduces new terms that will be used for regulatory tracking across Medtronic • All new terms have a common global definition • Some of the terms will be mapped to country specific regulatory procedures and terms as appropriate.

  7. 2. Common RAD DefinitionsProducts

  8. 2. Common RAD DefinitionsProducts • Each family has multiple products assigned to it within the database. • Each product may have multiple components FAMILY Product 1 Product 2 Component 3 Component 1 Component 2 Component 4

  9. 2. Common RAD DefinitionsProducts • Combination Product Notes • A combination product regulated as a drug in some countries and a device in others should have 2 families – one drug family and one device family • Combination products regulated consistently around the world should be created as a single combination product family using the definition that best aligns to how they are regulated.

  10. Common RAD DefinitionsSubmission Terms - Application • Applications are created under a family and contain multiple products • Applications are in one or more countries • Each country needs guidance on how these levels within the system will be used EXAMPLES • US – An original PMA is an application. • Europe – a Design Examination Certificate (CE Cert) is an application,

  11. Common RAD DefinitionsSubmission Terms - Event • Events are created under an Application • Events can be related to one or more products within the application • Each country needs guidance on how these levels within the system will be used EXAMPLES: • US – the original PMA is the first event under the application. Each PMA Supplement is an addition event under the PMA application • Europe – The first design dossier sent to get a CE Cert is the first event under the application. A change notification is an additional event under the certificate application • Japan -

  12. Common RAD DefinitionsSubmission Terms – Sequence & Assembly • Each sequence is related to one event • Each assembly is related to one sequence EXAMPLES • US – When the original PMA is sent, it is the first sequence under the PMA event. The first response to questions is a 2nd sequence under the event for the original PMA • Europe – When the original Design Dossier is sent to the notified body, it is the first sequence under the Design Dossier Event. The first response to questions is a 2nd sequence under the same event

  13. 2. Common RAD DefinitionsSubmission Terms Family 1 to many 1 to many Product Country 1 to many • Applications can relate to one or more products within the family • Events can related to one or more products within the application Application 1 to many Event 1 to many Sequence 1 to 1 Assembly

  14. 2. Common RAD DefinitionsOther Terms for Regulatory Tracking • References, Tasks can be associated with Project, Families, Products, Applications, Events or Sequences. • Registrations can only be associated with Applications and Events

  15. 3. System Components RAD is composed of 3 basic parts: • Documentum Webtop version 6.5 • InSight Publisher (IP) • InSight Registration Planning & Tracking (RPT) • RAD refers to all components of the system used together

  16. 4. Connection between System Components SAP (R3) Product Numbers Data for document properties and folder structure • Webtop 6.5 • Document creation • Routing and approval of documents • Regulatory archive for documents • InSight Manager (IP & RPT) • Data about submissions • Data about correspondence • Data about approvals • Reporting • Submission Publishing Documents linked to database records Approvals GTS

  17. Family Country Application Event Sequence System ConnectionsInSight entities & Webtop folders • Data is created in InSight first • You can then create folders in Webtop based on the InSight data • The system will automatically keep the folder name matching the InSight entity name

  18. System ConnectionsInSight entities & Webtop folders • Creation of new entities (e.g. families, products, applications, events and sequences) happens in InSight • As a 2nd step, corresponding folders are created in within Webtop • A configurable model was developed to map Webtop menu items (context) to template folder structure creation • Webtop user interface (UI) components were developed to connect to InSight real time for some properties to give a consistent view (e.g. products)

  19. System ConnectionsEMC Documentum (Business Object Framework) • RAD utilizes the Business Objects Framework • Type and Service based business objects (TBO and SBO) architecture was used for folders and documents • TBO features include: • Lifecycle assignment during the creation and import of documents (Note: special archive folder has a lifecycle) • Cascading of meta-data between the Regulatory tracking database and folder/document properties • SBO Features include: • Prune minor versions on approval • Assign major version number on approval • Dynamic folder creation based on Webtop menu context

  20. System ConnectionsEMC Documentum Workflow • Utilize workflow for review and approval • Approval process includes the option for electronic signature or just audit trail creation • The system provides the ability to manage collections of documents within a folder structure and route for review and approval • Document and Folder lifecycle management is controlled within the workflow process

  21. System ConnectionsFamilies

  22. System ConnectionsApplications

  23. System ConnectionsApplications

  24. System ConnectionsEvents

  25. System ConnectionsEvents

  26. 5. Differences from Old System • RAD is a new system – not an upgrade to the existing system • The old “Global Dossier” system is a highly customized system with a rigid structure – which makes it unreliable. • RAD relies on commercially available software configured for Medtronic

  27. 5. Differences from Old System • 01, 02, and 03 folders are gone • There will still be an area in Webtop for “local files” • Country folders are only created if there is a submission ( planned, under construction, or complete) • Product folders are created at a family level only

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