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RAD

Regulatory Affairs Domain Paving the way toward harmonized global submissions and tracking

RAD Overview

Regulatory Affairs Domain

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RAD

Overview

1. RAD Purpose & Benefits

2. Common RAD Definitions

3. System Components

4. Connection between System Components

5. Differences from Old System

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RAD

1. 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

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RAD

• 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 Purpose

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RAD

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

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RAD2. 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.

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RAD2. 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.

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RAD2. 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 1 Component 2 Component 3 Component 4

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RAD2. 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.

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RAD2. Common RAD Definitions

Submission Terms - Application

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,

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RAD2. Common RAD Definitions

Submission Terms - Event

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 -

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RAD2. Common RAD Definitions

Submission Terms – Sequence & Assembly

Sequence 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

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RAD2. Common RAD Definitions

Submission Terms

Family

Product

Country

Sequence

1 to many

Application

Event

1 to many

1 to many

1 to many

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

Assembly

1 to 1

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RAD2. 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

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RAD3. 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

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RAD4. Connection between System Components

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

Data for document properties and folder structure

Documents linked to database records

GTS

SAP (R3)

Product Numbers

Approvals

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RAD4. System Connections

InSight 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

Family

Country

Application

Event

Sequence

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RAD

• 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)

4. System ConnectionsInSight entities & Webtop folders

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RAD

• 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

4. System ConnectionsEMC Documentum (Business Object Framework)

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RAD

• 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

4. System ConnectionsEMC Documentum Workflow

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RAD4. System Connections

Families

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RAD4. System Connections

Applications

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RAD4. System Connections

Applications

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RAD4. System Connections

Events

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RAD4. System Connections

Events

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RAD

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

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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