1. Regulatory Affairs Domain
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
The RAD system gives us global view of all submissions, correspondence and approvals.

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 Definitions Introduction
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.
As we review the terms think about how they equate to local terms you currently use. New terminology is required to give us a common regulatory language across Medtronic. But of course local terms – particularly with they are used by regulators – will still be there. We recommend that your local procedures map regulatory terminology in your country to RAD system terminology.

7. 2. Common RAD Definitions Products
Family
Devices: A marketing brand name or other similar grouping that can be used to define a collection of customer facing numbers. Each Business Unit will have its own documented definition of a device family.
Drugs: The international non-propriety name assigned by WHO or the generic name assigned by USAN
Product
Device: customer facing number (CFN) providing the product features of form, fit, or function of an end item thereby distinguishing each product variation within a product
Drug: Each new combination of Generic Name, Concentration and Pharmaceutical Form (Dosage Form) is a drug product.
Components
Each product may be composed of multiple components. For example a kit may have 3 different device products. A combination product may have a drug and device component.
*The definition of a drug product is still under discussion.

8. 2. Common RAD Definitions Products
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. Combination Product Notes
2. Common RAD Definitions Products
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 Definitions Submission Terms - Application
A top level grouping that keeps related submissions together. For example in the US, a PMA groups the original PMA and all related supplements. The definition will vary for each country
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 Definitions Submission Terms - Event
A request to approve something, a notice to a regulatory agency of an intended change, or a change to a submission file maintained within Medtronic.
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 Definitions Submission Terms – Sequence & Assembly
The package of information sent to a regulatory agency at any one time. The “fedex box” for paper submissions, the sequence according to the eCTD definition for drugs.
Assembly
The collection of documents that makes up a sequence. For paper submissions this is a collection of binders, for electronic submissions it may be a CD.
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 Definitions Submission 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 Definitions Other Terms for Regulatory Tracking
Project
A grouping of events that support a common regulatory goal. For example, a manufacturing site change that requires multiple submissions to gain approval for all impacted products. Note: Medtronic only uses projects to group events within a single country
Reference
A record of correspondence, telephone log, or other information related to a submission.
Registration
The record of an approval
Task
An activity to be done that is associated with a submission, correspondence or product. Tasks can have due dates and be assigned to a specific person.
References, Tasks can be associated with Project, Families, Products, Applications, Events or Sequences.
Registrations can only be associated with Applications and Events

15. RAD is composed of 3 basic parts:
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
This slide shows at a high level how the various components of the system are related.
Documents linked to database records
Approvals
GTS

17. System Connections InSight entities & Webtop folders
Family
Country
Application
Event
Sequence
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 Connections InSight 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 Connections EMC 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. Utilize workflow for review and approval
System Connections EMC 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 Connections Families
A family is created in InSight (on the left). You can then create the family folder in Webtop based on the InSight field. The family name and the family folder name will always stay the same. Business Unit values and Product Number values on the family in InSight will show up on the family folder properties in Wetop.

22. System Connections Applications
An application is created in InSight (left screen). You can create an application folder in Webtop to match it. The name of the application and the name of the application folder will always be the same between InSight and Webtop. The application number in InSight will appear on the application folder properties in Webtop.

23. System Connections Applications
Product numbers on the application in InSight show up on the Product Info tab of the application folder in Webtop

24. System Connections Events
Events are created in InSight (left screen). You can then create a corresponding event folder in Webtop. The event name in InSight and the event folder name in Webtop will always match. The event number in InSight will always appear on the Event info tab of the Event folder in Webtop. If the event is part of a project in InSight, the project name will appear on the Event info tab in Webtop and the Project info tab will be populated with more information about the project.

25. System Connections Events
Product numbers on the event in InSight will show up on the Product Info tab on the event folder in Webtop.

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
To “plan” a submission, the geography needs to create the structure in InSight (Application, event sequence) to support it. Submissions could be “planned” the same day they are sent – though we would not encourage this as best practice.