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Moderator: Patricia Van Arnum Executive Editor Pharmaceutical Technology Speakers: Jake Doran IT Director, Global Regulatory Affairs Janssen R&D KR Karu Industry Solution Director, Pharmaceutical Sciences Sparta Systems

Ashley Watkins Industry Solution Manager, Pharmaceutical Sciences Sparta Systems

Jake Doran
IT Director, Global Reg Affairs Janssen R&D 11-June-2013

The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Janssen, its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved.

In this day and age there are no IT projects, every initiative is a business project with technological components!
People
Its not an administrative activity Cannot underestimate the cultural impact Organizational changes can be viewed as the impetus for advancement of process and technology Getting beyond business as usual Letting go of legacy Thinking and being transformational Change and transition management are critical success factors Discipline approach to driving efficiency and value

Process

Technology

Set of tools used to implement a new paradigm

Unification of R&D activities across numerous multinational Operating Companies

More than 80 Marketed Pharmaceutical Products

50 Operating Companies 100 Countries

Not centralization, still maintain decentralized model with regional and local OpCos

Business Goals

Improve how regulatory information is collected, accessed, managed, and consumed to enhance compliance, decision-making, and efficiency Achieve real-time and accurate submission, product, and registration information that supports Global Regulatory Affairs (GRA) and other divisions (R&D, Supply, Commercial etc.) Increase transparency of Central / Regional / LOC activities throughout the product life cycle

RIM

(Registration , Commitments, and HA Q&A)

Product Registration Management

Submission Portfolio Management

Authoring , Document Management, & Publishing

Enterprise Regulatory Information (Master Data) Data Quality & Governance Information Consumption, Data Warehouse, Metrics
9

Internal Drivers: Processes and systems do not easily allow a complete regulatory view Extensive manual effort required to verify information Many resources to support current technology and business process adherence External Drivers: Implement new HA Requirements: e.g. IDMP - medicinal product ID will drive standardized product definitions in 2015 HA Inspections are more sophisticated requiring a higher degree of readiness and compliance management (realtime access)

10

Consumption of Regulatory Data has Evolved

1) 2) 3) 4) 5) 6) GRA Global Regulatory Affairs GMS Global Medical Safety GCO Global Clinical Operations Manufacturing & Supply Chain QPPV Quality, PV PDMS - Pharmaceutical Development Manufacturing Sciences PMO - Portfolio Mgmt Office QA Quality Assurance Commercial (Sales and Marketing)
Commercial Companies GRA (LOC, regional, central) GCO Business Development Other R&D Groups

GMS

PMO

7) 8) 9)

Reg. Info

10) HCC Health Care Compliance 11) Due Diligence 12) External Development Partners 13) External Manufacturing Partners
Supply Chain CoMarketing Health Authorities Commercial Agents

11

Define Scope Initial Focus on Global Product Registration & Information backbone Doc Mgmt & Publishing are part of Longer Term Plans Understand Current Situation Visit the Trenches, Interviews, etc. Conduct Cross-Functional Workshops to Validate Current Situation and to Draft Future State Be Inclusive, Global Participation, Understand Industry Direction Produce Detailed Roadmap Highlighting Business Benefits Transition from Current -> Future Conduct Focus Groups to Vet the Strategy of Future State Gain Consensus and Support Conduct Executive Session and Present Case for Change Approval to Execute

12

Track & Archive

LOC Tool Set eTRACKER

GRAMM

LOC Tool Set

Local Submission Archive

SPS

GRAIL DMS EPOD

GRAIL DMS EPOD

LOC Tool Set Remedial RMS

Local Submission Archive

PMC LOC Tool Set TRACKER Remedial WRAT HAQ RMS

GRAIL
EPOD

DMS
PMC Tracker

MPD/PKB

Investigationa l Submissions

Ongoing HA Communicatio n

Initial Marketing Application (s)

Questions and Answers

HA Approvals

Commitment s Daily /Routine Submission

Post Approval Submissions

CTMS (GCO)
T-RACE

DMS EPOD (IND)

DMS
RCW (small molecule) Country Requirement s

EPOD

DMS SPS
RCW (small

EPOD Country Plan List Country Requirement s

GWRAT / Metrics

PUMA

Planning & Preparation

Country Distribution Lists

molecule)

PUMA (BIO)

SPS

Country Plan List

Local XLS

(BIO)

ERIS/SCOR EPOD E Country Plan SPS List

Country Distribution Lists

RCW

(PRD) PUMA (BIO) Country Country Distribution Requirement Lists s

Legend
Planning
Search / Metrics Reference

Publishing Touch Points GWRAT / Metrics

100s
E-mail

Content
RI & Tracking

LOC Tools

Publishing Suite of Tools

www.diahome.org

Used extensively in each step

Drug Information Association

13

Simplify Global Working Environment

+

Resource (authoritative source for submission planning and tracking regulatory information) Optimization

Efficiency / Cost &

Confidence in the Quality of the Information

(accuracy, timeliness, data standards, and accountability)

Compliance and Productivity

Effective Transition Management to Enable the Change

(practical approach to support people through the change)
User Interface

Efficient & Consistent Execution

Local Regional Central Partners

Submission Planning and Product Registration Information

Process / Role Design Authoritative Source Data Quality Standardize Data Information Consumption

Investigationa l Submissions

Ongoing HA Communicatio n

Initial Marketing Application (s)

Questions and Answers

HA Approvals

Commitment s Daily /Routine Submission

Post Approval Submissions

14

2013
Mobilize Project and CAR Strategy /Development Detailed Planning and Resource Evaluation

2014

2015
*Illustrative Purposes Only

Submission Archive Policy and Scalability Submission Portfolio Management Determine long term Strategy Regulatory Information Consumption Define Requirements

(Placeholder as Data Warehouse / Dash Board actions dependant on 2013/14 actions)

Information Consumption Implementation

Combine Submission Portfolio & Product Reg. capability or not

Product Registration Capability

CAR related

Decommission Systems

LOC Tool & Infrastructure Review

Requirements Definition
High Level E2E Process Design

Process & Role Design ---- Configure ---Prototype---Test / Validate---- Migrate Data ---Deploy
P

Solution Evaluation & Procurement

Commitments / Corresp. V M D

CTA Tracking
P V M D P

Full Product Registration V M

Upgrade for IDMP

D P V M D

Data Migration Analysis, Cleanup, and Automation

Regulatory Information Backbone

Define Master Data / Terminology Plan & Start Data Cleanup Design Data Architecture and security model

P V M D

Process Design Test & Validate Migrate Data Deploy Policy Decision Requirements Review Dependency

Data Governance Strategy - Data Verification Methods and Qualification Model Change and Transition Management, Program Governance www.diahome.org

Drug Information Association

15 15

Demonstrate Compliance Real-time access to regulatory status of all products Support other divisions compliance (e.g. commercial product release) Provide (global) shared transparency on upcoming regulatory activities without contacting all involved parties up front Reduce the number and complexity of SOPs to manage compliance

Improve Support for Internal and External Audits

Inspection relevant information can be reported ad hoc from any location Ability to produce internal metrics for compliance related activities Support Emerging Agency Data Standards

Integrate new standards (XEVMPD, IDMP) using existing and robust regulatory information

Productivity / Efficiency Gains Reduce by 50% the time to find and verify the quality of regulatory information Productivity gains will support the increased number of submissions with current headcount Interactive sharing of up to date regulatory status information

16

Benefits Local and Regional Offices Reduce redundant data entry including time spent duplicating information in local trackers (100s) Reduce (or eliminate) time required to respond to redundant queries from regional hubs and central (HQ) Redundant data entry and redundant queries account for 20% - 30% of time spent

(focus group data)

Consolidated Environment Reduce redundant data entry / processes Reduce number of central, regional; and local systems that track regulatory status information Manage cost by simplifying the system footprint Resource reallocation: Time spent upgrading and maintaining multiple smaller systems (business and IT)

17

 Project

vs. Program on Data Governance between Organizations

Emphasis

Interconnectivity

and Systems

Re-think Ensure

and Simplify Information Consumption Ample Resources to Address Change and Transition Management
18

Registration Management as Part of an Enterprise Regulatory Management System

KR Karu Industry Solution Director

Ashley Watkins Industry Solution Manager

Enterprise Quality and Regulatory Systems: A Broad Scope of Usage

EHS
Incident Management Action Item Tracking Audits CAPA Recurring Commitments Risk Assessments

Regulatory Affairs
Registration Tracking Correspondence Tracking Commitment Tracking Audits Issue Tracking/Deviations CAPA Change Management Adverse Event Reporting Deviations/OOS CAPA

R&D
Preclinical/ Clinical
GCP/GLP Audits Clinical Trial Registrations Service Provider Mgmt Deviations/Incidents CAPA Change Management Lab Investigations

Commercial Manufacturing
Deviations

Quality

Complaints Lab Investigations CAPA Change Management Batch Record Review Audits Supplier Management Recalls/Withdrawals Training Management

Change Management Audits Batch Record Review

Harmonized Audit Management

20

Product Registration Tracking

What: product registration is the act of gaining permission to sell products to a particular country
- Initial approval - Recurring approval - Certain product changes

Who: product registration is commonly managed by regulatory affairs

How: each country has its own rules, requirements, timelines and renewal timeframes
- Each product must be registered in each country, as well as each variation of the product

Registration Process Description

Market Authorization attained via the following: National Procedure (NP)
- Used when a standard application is made for the first time in a single member state (EU)

Mutual Recognition Procedure (MRP)

- Means that EU countries may approve the decision made about a product by another EU country

Decentralized Procedure (DCP)

- For products that have not yet received authorization in any EU country, and would like a mutual recognition

Centralized Procedure (CP)

- Used for product authorization in all EU countries through the EMA

Product Registration
Substance
Aspirin

Product Product Product Product Product Product Product Product

Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration Registration

Registration

National National National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration National Registration Registration Registration

National Registration

Registration Process Description

1 Agency, 1 Country

Registration Process Description

1 Agency, Multiple Countries

Registration Process Description

Multiple Agencies, Multiple Countries

Product Registration Tracking

Data Element
Product Information

FAQs
What are the approved specifications? Is manufacturing in sync with product designs? What products have been approved? What are the planned changes? (i.e. release of revised formulation, process/test, and site facility changes) Where can we ship products? Are there any local deviations from the original dossier? What needs to be put on the label? What is the insert content? Where can we manufacture? Are we manufacturing according to high standards promised to the authorities? Who are my approved suppliers? What are the storage conditions?

Approval Status and Date

Approved Geographic Location Packaging and Labeling Manufacturing Steps

Product Lifecycle

28

Pharmaceutical Process Lifecycle

Submissions Publishing Doc Management

New Indications Cost effective manufacturing Change in process Change in ingredients Change in manufacturing location

Start limiting production Plan for plant reconfiguration

Development

Approval & Launch

Growth/Maturity

Decline

Regulatory Information Process

29

Managing Regulatory Affairs Processes

Product Registration Database

Product Registration Database

Pharma Regulatory Affairs Solutions

Regulatory Affairs Solutions

Solutions for tracking and managing: Product registrations Correspondence and commitments with regulatory bodies EVMPD submissions

XML

</>

EMA

Enterprise Regulatory Management System (ERMS)

One harmonized system Brings together all of the data from your decentralized and disconnected systems Provides management a dashboard view of all registration activities
- Global view of all locations where product has been approved for sale - Global view of all registration activities
Is anything overdue? What is the workload for any future period of time?
Resource planning

Pre-built registration processes with user-configurable flexibility for company specific requirements
- Automates EVMPD submission information to EMA countries

Configurable security so users can be limited to view only their areas of responsibility
33

Enterprise Regulatory Management System (ERMS)

Automates product registration tracking process Decreases time-to-market Reduces manual efforts Eliminates duplication of efforts Prevents missed deadlines by managing renewal schedules Streamlines communication Tracking of worldwide regulatory correspondence and commitments in a single global system Interaction between internal parties, contractors and regulators on action items Assignment of commitment tasks and due dates with visibility to status
34

Enterprise Regulatory Management System (ERMS)

Can be linked directly to global change control process When a change may affect product, registration and correspondence activities can be automatically triggered for authorities that have granted market authorization Creates a closed loop on the change process Creates visibility to be able to answer the tough questions:
- What can we sell where? - When can we sell it there? - Do we owe the regulators anything?

35

ERMS Dashboards and Analytics

Data access and visibility
ERMS provides a single dashboard that allows you to identify:
All product registrations by country Current product registration status Product registration due in 30/60/90/120 days Expired product registrations Pending regulatory authority activity Whether all products are properly registered and authorized for sale

ERMS provides the country- and region-specific ability to:

- Analyze product registration in a particular country or with a specific affiliate - Scorecard your affiliate based on real performance - Identify affiliate issues and resource limitations - Speed RA activity to maintain authorization to sell a product

ERMS provides real time data to the supply chain for immediate product distribution by country or regions

36

EVMPD
Registration Tracking Solution EVMPD eReporting Solution Substance Product
EVMPD EVMPD messages Registration messages Messages

Registration
National Registration
Supporting Supporting Records Supporting Records Supporting Records Records

EudraVigilance Medical Product Dictionary

EVMPD EVMPD messages Return messages Messages

Pharmaceutical Registration Tracking

Substance Product
Registration Template

Registration

Entities
EVMPD Message Medical Device
Pharmaceutical Dose

ATC Code

Variation

National Approval

Renewal

Document

Administration Route

Correspondence

Commitment

The Value of an Enterprise Regulatory Affairs Solution

Automate the Product Registration Tracking Process Decrease time to market Reduce costs and manual efforts Prevent missed deadlines by managing renewal schedules Automate EVMPD submissions to EMA Streamline Communication Track regulatory correspondence and commitments in one system Interact with internal parties and regulators on action items

Leverage Your Current Investments Reduce TCO by managing RA processes in your quality system Ensure consistent information Effectively manage global requirements Increase process efficiency and transparency

Future State

Future ERMS vision

Doc Submissions FDA EMA Data Registration Mgt/Admin RA Activity
Correspondence & Commitments

Inputs

Executive Sponsorship

Forces of Change

Enterprise Regulatory Management System

Industry Best Practices Regulatory Requirements & Initiatives Process Harmonization Data Harmonization

ANALYTICS DASHBOARD

Global Reportability Global Visibility Accelerate Product to Market Globally Harmonized Process

Global harmonized reportability Global visibility to change

GLOCAL

EYE TO THE FUTURE

FDA EMA

Mobile Solutions and ERMS

Analyze product portfolio available any time, anywhere Remote approval capabilities means no longer needing to wait to log on to the network to view and approve documents On-the-go access to data and analytics

42

Extending ERMS Beyond the Enterprise

Streamline RA activity beyond the corporate four walls Connect companies to affiliates and regulatory agencies Maintain security of product data behind the firewall Increase transparency to the global product registration ecosystem

On Premise

ERMS

ERMS Cloud

Global Affiliates
43

Summary
ERMS is a system of process Process Management <> Content Management
- Two different types of software - Documents are often linked to ongoing processes

Change management is the main driver for variations to registrations once product is being marketed Having management and global visibility to status of ongoing processes help reduce time of processes thereby creating efficiencies, which can speed time to market It is critical to have a global system of record

44

Questions?
Thank You