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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 Regulatory Affairs Domain
Overview • RAD Purpose & Benefits • Common RAD Definitions • System Components • Connection between System Components • Differences from Old System
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
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
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
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.
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
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.
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,
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 -
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
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
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
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
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
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
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)
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
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
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
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
