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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
7
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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
8
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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)
10
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Consumption of Regulatory Data has Evolved
11
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
12
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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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14
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
15
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)
17
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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
18
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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
20
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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Registration Process Description
1 Agency,
1 Country
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Registration Process Description
1 Agency,
Multiple Countries
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Registration Process Description
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
28
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Pharmaceutical Process Lifecycle
29
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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Enterprise Regulatory Management System
(ERMS)
33
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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Enterprise Regulatory Management System
(ERMS)
34
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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Enterprise Regulatory Management System
(ERMS)
35
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
36
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
42
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
43
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
44
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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