Ensuring Global Reg Compl 4 Product Reg

7/28/2019 Ensuring Global Reg Compl 4 Product Reg

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Moderator:Patricia Van ArnumExecutive EditorPharmaceutical Technology

Speakers:Jake DoranIT Director, Global Regulatory Affairs

Janssen R&D

KR KaruIndustry Solution Director, Pharmaceutical Sciences

Sparta Systems

Ashley WatkinsIndustry Solution Manager, Pharmaceutical SciencesSparta Systems


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Jake DoranIT Director, Global Reg Affairs

Janssen R&D

11-June-2013


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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.

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In this day and age there are no IT projects, every initiative is abusiness project with technological components!

People Its not an administrative activity

Cannot underestimate the cultural impact

Organizational changes can be viewed as the impetus foradvancement of process and technology

Process 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

Technology Set of tools used to implement a new paradigm

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Unification of R&D activities across numerous multi-national Operating Companies

More than 80 Marketed Pharmaceutical Products

50 Operating Companies

100 Countries

Not centralization, still maintain decentralized model with

regional and local OpCos

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Business Goals

Improve how regulatory information is collected, accessed, managed, andconsumed to enhance compliance, decision-making, and efficiency

Achieve real-time and accurate submission, product, and registrationinformation that supports Global Regulatory Affairs (GRA) and otherdivisions (R&D, Supply, Commercial etc.)

Increase transparency of Central / Regional / LOC activities throughout

the product life cycle

9

ProductRegistrationManagement(Registration ,

Commitments, andHA Q&A)

SubmissionPortfolioManagement

Authoring ,DocumentManagement,& Publishing

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

RIM


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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 - medicinalproduct ID will drive standardized product definitions in2015

HA Inspections are more sophisticated requiring a higherdegree of readiness and compliance management (real-time access)

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Consumption of Regulatory Data has Evolved

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Reg.Info

GMS

Business

Development

Other

R&D

Groups

PMO

Co-

Marketing

Commercial

Agents

Health

Authorities

Supply

Chain

Commercial

Companies

GRA

(LOC, regional,

central)

GCO

1) GRA Global Regulatory Affairs

2) GMS Global Medical Safety

3) GCO Global Clinical Operations

4) Manufacturing & Supply Chain

5) QPPV Quality, PV

6) PDMS - PharmaceuticalDevelopment ManufacturingSciences

7) PMO - Portfolio Mgmt Office

8) QA Quality Assurance

9) Commercial (Sales and Marketing)

10) HCC Health Care Compliance

11) Due Diligence

12) External Development Partners

13) External Manufacturing Partners


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Define Scope

Initial Focus on Global Product Registration & Informationbackbone

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

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Drug Information Association www.diahome.org 13

Investigational SubmissionsOngoing HACommunication

InitialMarketingApplication (s)PostApprovalSubmissions

Questionsand Answers HAApprovals

CTMS(GCO)

MPD/PKB

RCW (smallmolecule)

PUMA (BIO)

GRAIL

PMCTRACKER

eTRACKER

Country PlanList

CountryRequirement

s

RemedialRMS

GRAMM

SPSRCW (small

molecule)PUMA (BIO)

EPOD

EPOD

CountryRequirement

s

EPOD

Country PlanList

SPS

RCW (PRD) PUMA (BIO)

ERIS/SCORE EPOD

CountryRequirement

s

Local SubmissionArchive

CountryPlan ListSPS

GRAIL

EPOD

Local XLS

LOC Tool Set

LOC Tool SetLocal Submission

ArchiveLOC Tool Set

WRAT HAQ

LOC Tool Set

PublishingSuite of Tools

Publishing TouchPoints

EPOD (IND)

GWRAT /Metrics

CountryDistribution

Lists

Commitments

PMC Tracker

T-RACE

Pan&Peao

Ta&Archv

SPS

Daily/RoutineSubmissionGWRAT /Metrics

Planning

Search /Metrics

Content

RI & Tracking

Reference

Legend

LOC Tools

CountryDistribution

Lists

CountryDistribution

Lists

DMS

DMSDMS

DMS

DMS

GRAIL

EPODDMS

E-mail Usedextensively in

each step

100s

RemedialRMS


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Effective Transition Management to Enable the Change(practical approach to support people through the change)

Confidence in the Quality of the Information(accuracy, timeliness, data standards, and accountability)

Simplify Global Working Environment(authoritative source for submission planning and tracking regulatory information)

+

+

Efficiency / Cost &ResourceOptimization

ComplianceandProductivity

Efficient &ConsistentExecution

Investigational SubmissionsOngoing HACommunication

InitialMarketingApplication (s)PostApprovalSubmissions

Questionsand Answers HAApprovals Commitments

User Interface

Daily/RoutineSubmission

Submission Planning and Product Registration Information

Process / Role Design Authoritative Source Data Quality Standardize Data

InformationConsumption

Local Regional

Central Partners


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Drug Information Associationwww.diahome.org 15

2013 2014 2015Mobilize

Project andCAR Strategy

/Development

DetailedPlanning

andResourceEvaluation

Regulatory Information BackboneDefine

Master Data/

Terminology

Design DataArchitecture

and security model

Plan & StartData

Cleanup

RegulatoryInformation

Consumption Define

Requirements

Data GovernanceStrategy - Data

Verification Methods

and Qualification Model

Dependency

RequirementsReview

Policy Decision

Migrate Data

Deploy

Test & Validate

Process DesignP

V

M

D

SubmissionPortfolio

Management Determine longterm Strategy

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LOC Tool &Infrastructure

Review

Change and Transition Management, Program Governance

Submission

ArchivePolicy andScalability

Information Consumption Implementation(Placeholder as Data Warehouse / Dash Board actions

dependant on 2013/14 actions)

Product Registration CapabilityRequirements Definition Process & Role Design ---- Configure ---Prototype---Test / Validate---- Migrate Data ----

Deploy

SolutionEvaluation

& Procurement

High LevelE2E Process

Design

Data Migration Analysis, Cleanup, and Automation

Commitments /Corresp.

P V M D

CTA Tracking

P V M D

Full ProductRegistration

P V M D

Upgrade for IDMP

P V M D

Decommission Systems

Combine Submission Portfolio& Product Reg. capability ornot

CAR related

*Illustrative PurposesOnly


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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 withoutcontacting 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 currentheadcount

Interactive sharing of up to date regulatory status information

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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 hubsand 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 statusinformation

Manage cost by simplifying the system footprint

Resource reallocation: Time spent upgrading and maintaining multiple smaller systems(business and IT)

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Project vs. Program

Emphasis on Data Governance

Interconnectivity between Organizationsand Systems

Re-think and Simplify InformationConsumption

Ensure Ample Resources to Address Changeand Transition Management

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KR Karu

Industry Solution Director

Ashley Watkins

Industry Solution Manager

Registration Management as Part of an

Enterprise Regulatory Management System


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Clinical Trial Registrations

Enterprise Quality and Regulatory Systems:

A Broad Scope of Usage

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Quality

R&DCommercial

Manufacturing

CAPA

Change Management

Complaints

Deviations

Recalls/Withdrawals

Supplier Management

Batch Record Review

Lab Investigations

Training Management

Audits

Batch Record Review

CAPA

Audits

GCP/GLP Audits

CAPA

Change Management

Change Management

Deviations/Incidents

Deviations/OOS

Lab Investigations

Action Item Tracking

Audits

CAPA

Incident Management

Recurring Commitments

Risk Assessments

Harmonized Audit Management

Adverse Event Reporting

Audits

Correspondence Tracking

Commitment Tracking

Issue Tracking/Deviations

Registration Tracking

CAPA

Change Management

Service Provider Mgmt

EHSRegulatory

Affairs

Preclinical/

Clinical


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Product Registration Tracking

What: product registration is the act of gaining permission to sellproducts 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 andrenewal timeframes

- Each product must be registered in each country, as well as each

variation of the product


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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 EUcountry, and would like a mutual recognition

Centralized Procedure (CP)

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


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Product Registration

Substance Aspirin

RegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistrationRegistration

ProductProductProductProductProductProductProductProduct

National RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational RegistrationNational

Registration


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1 Agency,

1 Country


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1 Agency,

Multiple Countries


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Multiple Agencies,

Multiple Countries


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Product Registration Tracking

Data Element FAQs

Product Information 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 revisedformulation, 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?

Manufacturing Steps

Approval Status and Date

Approved Geographic

Location

Packaging and Labeling


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Product Lifecycle

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Pharmaceutical Process Lifecycle

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Development Approval & Launch

New Indications

Cost effective

manufacturing

Change in process

Change in

ingredients Change in

manufacturing

location

Growth/Maturity

Start limiting

production

Plan for plant

reconfiguration

Decline

Regulatory Information Process

Submissions

Publishing

Doc Management


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Managing Regulatory Affairs Processes

Product

Registration

Database

Product

Registration

Database


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Pharma Regulatory Affairs Solutions


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Regulatory Affairs Solutions

Solutions for tracking and managing: Product registrations

Correspondence and commitments with regulatory bodies

EVMPD submissions

EMA

XML


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(ERMS)

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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 forcompany specific requirements

- Automates EVMPD submission information to EMA countries

Configurable security so users can be limited to view only their areas ofresponsibility


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(ERMS)

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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 andcommitments in a single global system

Interaction between internal parties, contractors and regulatorson action items

Assignment of commitment tasks and due dates with visibility tostatus


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(ERMS)

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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?


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ERMS Dashboards and Analytics

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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-specificability 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 aproduct

ERMS provides real time data to the supply chainfor immediate product distribution by country orregions


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EudraVigilance

Medical Product

Dictionary

EVMPD

messagesEVMPD

messages

EVMPD

Supporting

RecordsSupporting

RecordsSupporting

RecordsSupporting

Records

Registration TrackingSolution

Substance

Product

Registration

National

Registration

Registration

Messages

EVMPD

eReportingSo

lution

EVMPD

messagesEVMPDmessagesReturnMessages


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Product

Registration

Substance

EVMPDMessage

Medical

Device

Pharmaceutical

Dose

ATC Code

Document

Administration

Route

Entities

RegistrationTemplate

VariationNational

ApprovalRenewal

CommitmentCorrespondence

Pharmaceutical Registration Tracking


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The Value of an

Enterprise Regulatory Affairs Solution

Leverage Your Current Investments

Streamline Communication

Automate the Product Registration Tracking Process

Track regulatory correspondence and commitments in one system

Interact with internal parties and regulators on action items

Reduce TCO by managing RA processes in your quality system

Ensure consistent information

Effectively manage global requirements

Increase process efficiency and transparency

Decrease time to market

Reduce costs and manual efforts

Prevent missed deadlines by managing renewal schedules

Automate EVMPD submissions to EMA


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Future State


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Doc Data

FDA

EMA

Submissions RA ActivityRegistration

Mgt/Admin

Inputs

Forces of

Change

FDA

EMA

EYE TO THE

FUTUREGlobally Harmonized Process

Executive Sponsorship

Industry Best Practices

Regulatory Requirements& Initiatives

Process Harmonization

Data Harmonization

Enterprise Regulatory

ManagementSystem

Global Reportability

Global Visibility

Accelerate Product to

Market

$

ANALYTICS DASHBOARD

GLOCAL Global harmonized reportability Global visibility to change

Correspondence &

Commitments

Future ERMS vision


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Mobile Solutions and ERMS

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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


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Extending ERMS Beyond the Enterprise

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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


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Summary

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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 toregistrations 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


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Questions?

Thank You


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Ensuring Global Reg Compl 4 Product Reg

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