Moving to digital labeling: Journey to achieving Desired Outcomes

Moving to digital labeling: Journey
to achieving Desired Outcomes
Dr. Sonica Batra
Associate Vice President,
Regulatory and Medical,
Indegene
Vladimir Penkrat
Associate Vice President - Global
Head of Safety & Regulatory
Affairs, Indegene

2
Agenda
Industry challenges & Health Authority changes
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2
3
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The future demands in labelling
Industry initiatives to advance label business operations
Process mapping and investigation
Technology assessment and implementation
Objectives to outcomes
© 2023 Indegene. All rights reserved.

3
Labeling: Historical Evidence of Challenges
>50% of medication
errors are due to drug
labeling
No current Standard for
the CCDS
>10% of errors due to
Quality / Compliance
Checks missed
Technical competency
for XML based label
requirements
Traceability of decisions
and Risk of counterfeit
>25% of labelling delays
due to incorrect templates
and style guides

4
These challenges have an impact: e.g. recalls & counterfeits
• Recalls between January 2017 and September 2021:
• Most were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls
• Fighting Counterfeit through Serialization, traceability and other regulations

5
.. But Labeling Regulations Are Moving to Digital – Examples
Implants and Class III Class IIa and IIb Class I
UDI on Device Labels
Article 123.3.f and article 27.4
May 26, 2021 May 26, 2023 May 26, 2025
Direct marking on reusable devices Article 123.3.g and article 27.4 May 26, 2023 May 26, 2025 May 26, 2027
Europe, there is ongoing work to improve communication to patients, amongst others through
electronic product information (ePI)
e-PIL pilot with pharmaceutical industry and the regulatory authorities in Belgium and Luxembourg.
New electronic labelling for human prescription drugs "Electronic media in prescription drug labelling“
Improving patient safety and health systems resilience through the use of electronic labeling
EU MDR changes including UDI per EU MDR 2017/745

6
…With Strides to Combat Counterfeit Efforts through New Data
Requirements …
Drug Supply Chain Security Act (DSCSA)
Implementation Timeline
Inclusion Requirements
• Serial Number
• National Drug Code (NDC)
• Batch number
• Expiration date

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… And A Priority Focus on Patient Needs: e.g.: Health Literacy
“Health literacy occurs when a society provides accurate health information and services
that people can easily find, understand, and use to inform their decisions and actions.”
Healthy People 2030 Health Literacy Definition Public Comments
Flesch Reading Ease is one of the oldest and most accurate readability
formulas applying Fleish Kinkaid scores applying an algorithm. Inputs
are sentence length and number of syllables per word.
90-100 Very easy
80-90 Easy
70-80 Fairly easy
60-70 Standard
50-60 Fairly difficult
30-50 Difficult
0-30 Very difficult
European Product Information (ePI) is taking initiative in literacy as well

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Need of the hour: Future Ready Labelling Requirements
Towards the ultimate
Objectives:
Ensure consistency, accuracy, and quality in labeling;
Reduce cycle time and costs
Ensure compliance
and patient safety:
topmost priority
Reduce the number
of labeling templates
Minimize the need for
relabeling
Connect planning,
content, and output
submissions with the
same information
Timely and accurate
Regulatory Authority
communications and
query management
First time right -
labeling and artwork
quality process
Accelerate time to
market but reduce
waste in print
manufacturing
Transition from paper
based to digital
automated systems

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Apply A Framework for Process Redesign
How optimized is the Labelling process flow?
• What are the stages/ steps in end-to-end labelling &
artwork process, and what are the tasks carried out in
each stage?
• How are the labelling & artwork milestones recorded for
core and country labelling documents ? How are the
various hand-offs managed in the systems/platforms?
What are the roles and responsibilities?
• Who are the stakeholders, what are their roles/
responsibilities?
• Are there overlaps/ missing roles, are there
redundancies or capacity constraints across Regulatory,
Legal, Market coordinators and QA team?
What are structures/ artifacts in place?
• To ensure quality and compliance at every stage/
step of the process
• To ensure the deviations are being managed
• To evaluate vendor performance
• For information exchange, collaboration, on-the
job support (artifacts, guidelines, checklists)
How technologies are being used
• What are the systems/ tools used in the labelling
& artwork process – proofing, code creation and
harmonization of labelling content etc.?
• How do they integrate with the process?
• How are digital assets stored, managed and
tracked?
• What is the planned future roadmap?
How is the process being monitored and
performance being measured?
• Which process/ people KPIs/ metrices are tracked
for label & artwork creation and update, HA query
management and implementation & distribution?
• What accountability measures are in place
What’s the current maturity and what should be done to move toward best-in-class?
Comprehensive ‘as-is’ Picture
Identifiy gaps &
remediation plans
Process Technology
People

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1st: Identify Labelling Failure Points around People, Process &
Technology
Difficult
challenge
Common
Challenge
Cross functional
challenge
Responsibility
for Readability
Transcription
errors
Global, Local
cross-functioning
Knowledge of XML / style
Standards & training
Multiple
Stakeholders Opinions
Reduced Agility in
responding to
regulatory changes
Complex, Non
centralised/
fragmented
Local Nuanced regulations,
standards, style guides
Limited tracking of SOP adherence.
Label Version
Control &
Aggregation
Label Lifecycle Planning, Implementation
& Tracking; HA Query management
Retrospective Content
Harmonization
People
Process
Visibility and Governance
between Global Position and
Local Market Actions
Complex
technology
Non Compliance
Cost of
scaling up
Siloed
Information
Systems
Manual
operational
processes
Limited
Insights/Analytics
on operations
Transferance
across
markets
Technology
Adoption
Technology and
Analytics
Competence
and skill issues
Non Conformance

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Sample label and artwork issues
Quality Compliance Process
Issue Observation RCA/ Symptoms Action / Solution
Content deviation Label was created for initial registration
but missed AE Mouth haemorrhage.
Reference label in PDF format did not allow for
effective document comparisons by the LM.
Enhancement of the QC process for all file types
Rework & high iterations Rework ratio for Arabic leaflet was >
50%
Arabic being complex language had to be checked
manually and the proofing tool did not support the
text comparsion
Lingusitic expert and use of plug-in to support
Arabic text; RFT increased to 85%
Content Inconsistency
Content Inconsistency in different
sections across the same Label in case
of hybrid referencing
Local product label is a hybrid label (Referenced on
CDS and USPI). The infusion durations mentioned
in both reference labels were inconsistent.
Diligent quality check must be done to ensure
that the information is consistent across the
references used.
Editorial error The word "ARM" in the table header of
Table 9 was not seen/hidden in the local
product label submitted to Health
Authority
Since many other tables in this document had
empty columns, author missed to do a thorough
formatting check to ensure if any content was
present in the empty space of Table 9.
The formatting marks should be turned on while
working on the document.
Editorial error
The Hydrogen atom was deleted in the
structure for Piperacillin label
Inadvertent deletion of content in the document and
not comparing the documents before dispatching it
to the client.
The editorial team should ensure that all the
documents are compared against the document
received.
Content inconsistency
Indication Section of local product label
was not aligned as per current effective
reference label - Core Data Sheet
Author assumed that the indication section must
be retained "as is" since it is the revision of the
initial draft which was sent for registration.
Every section of the local product label is to be
checked thoroughly by all the stakeholders and it
must be aligned as per the reference label.
1 3
2
Quality
1

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Issue Observation RCA/ Symptoms Action / Solution
Guidelines Requirements of excipient guidelines not reflective updates not properly communicated
'Tightened 'Regulatory intelligence newsletters to callout
“confirmed” change-inducing guidelines v/s “inviting-industry-
views” phase
Internal transitions / Hand-offs Some recent adverse event wording changes were not
reflected in the label for certain country
Lack of documentation with transition between Hub Labelling
Managers
Structured transition /hand-off format was introduced to deliver
internal transitions seamlessly
Risk Information in IFU
A Top 3 Device company was struggling with
maintaining alignment on the risk information present in
the Instructions for Use (IFU) documents.
Based on the RML, IFUs had to be updated to align the risk
information across geographies
Successful completion of 200+ RMLs and 300+ IFUs updated
with 100% compliance.
Locating clinical overviews
Requirement of Clinical overview (CO) for submission
purposes
For submission of labels to HA as a justification, we need to
provide CO which is difficult to locate. Sometimes Tailored CO
is required in addition to general CO.
A recommendation of the proper linking of the CO to the labels is
proposed with use of a structured content authoring solution.
HA triggered deviations
Deviation Management & Traceability not captured
If deviation is triggered by the HA , LM does not track this as a
deviation and tracing the origin becomes challenging
Modified the tracking system to allow for HA query as the
justification of change
Technical Specifications
Incorrect technical specification leading to multiple
iteration
Updated technical specification not available during artwork
creation
Review of the TS before artwork creation and adding the new
specs along with the artwork files
p Observation RCA/ Symptoms Action / Solution
Translation (HA requirement) Abbreviations not aligned to reference SOP for some
specific countries
Language nuance of abbreviations for certain languages were
missed
Translation supplier CAPAs were activated and monitored in the
governance. Penalty clauses were introduced
Inconsistencies in Label change
request
Inconsistency across components within the change
order
Inconsistency/Missing of annotations, e.g address, colours,
dosage etc
Upstream review of source document before the finalization
Standardization of process Varied approach for Mockup and commercial artwork
Use of different platform for execution of work leading to
communication gap and tracking
Use of single platform for both mockup and commercial artwork
for better traceability
Content deviation
Missed comments across multiple inputs from a local
country officer for a paediatric population update on the
label.
Three files were provided with associated comments. One
from the RA country officer, 1 from medical and one from
Please Review. LM missed medical comments and data for
paediatric population
Access was updated to make sure online access is available for all
resources. A revision on the tracking system to ensure clarity on
all sources of documented observations are called out so each can
be reconciled.
Compliance
2
Process
3

13
2nd: Map the Labeling Process and Opportunities to Automate HA
Approval
Trigger
Label Impact
Assessment
Label Creation/
Update
HA Submission &
Query Management
HA
Approval
Label Lifecycle
Management
Distribution
Notification of
CDS creation/
update
Impact Assessment &
Content Alignment Check
Create/
Update CDS
Review and
Approve the
CDS
Post
approval
tasks
Notification
to local
markets
Country-driven
request for new
product
launch/Line
extension/CMC
change/PV signal
Create/Update US label
Create/Update EU label
ROW labels:
Country Specific label
creation/update
CDS
Creation/
Update
Local
Label
Creation/
Update
Biosimilar
Product
Label
Creation/Update
Communicate
to the key
stakeholders
Artwork
Creation/
Update
Submission
to HA for
approval
HA
Query
management
HA
Approval
Label
Lifecycle
Management
Periodic
Monitoring of
reference
label/reference
label update
Impact Assessment &
Update biosimilar label
Review and Approve
the biosimilar label
Submission
to HA for
approval
HA Query
management
HA
Approval
Assessment of HA response and proceed to label update if needed
1
1
1
2
2 3
2
3
3 3
3
Impact Assessment &
against CDS
2 3
Industry
Pitfalls
• Maintaining regulatory labelling
requirements
• Collaboration
• Training maintenance
• Adaptability to change
• Knowledge gaps
1
People
• Complex and varied regulatory
requirements across the globe
• Frequently changing regional nuances
• Hybrid labels & nuanced market-specific
formats
• Publishing approach
2
Process
• Data duplication
• Disparate systems
• Information/intelligence in multiple
formats
• Manual Label workflow management
• Knowledge gaps
3
Technology
Print and
Track

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3rd: Prioritize Target Needs à Refine Objectives à Execute a Plan
Identify
improvement
opportunities
Select
processes for
automation
Explore and
incubate in
sandbox
Business case
justification and
roadmap
Prepare
Operations
& Deploy
Measure
Outcomes
Value
creation and
change
readiness
1
2
3
4
5
6
Failure Mode (example) Priority
Traceability of decisions in local
labels
2
Local Regulatory requirements
for templates, style, data
2
Confusion in ownership of Work
allocation causing delays from
GLL to label manager
2
Delay in Communication to
Regulatory for submission
1
Data accuracy and Quality in
AEs included
1
Resources to apply style guides
and formats are poorly utilized
3
# Objectives (example)
1
Implement Work
Allocation for Label
change Requirements
2
Establish system to
ensure accurate
templates are applied
3
Employ dashboards to
monitor timelines and
submission plans

15
4th: Evaluate Relevant Opportunities From Across
The Industry
Readability / Patient
friendly language
Converters / assessors
Creation of Core Patient
Information Leaflets
Integrated digital Quality
checklists
Digital Publishing &
Submissions
Modern Label Management
System
Traceability & Structured
Content Authoring
e-Labelling / ePI
introduction to eliminate
paper approaches
Intelligent Labelling
Centers and Analytics
XML / HL7 Based
Standards conversion
solutions
Global monitoring to
regulatory requirements
using AI
Label to Claims, ISI,
Artwork Integration
HA Query Analytics and
Insights
A B C
D E F
G H I
J J L

16
5th: Execute A Labelling Technology Roadmap For Change
Labelling
Technology
Technology &
Automation
Process &
Training
Implement and Measure
Outcomes at Scale
Pilot and
evaluate impact
Prepare Labelling
for Change
Readiness
Define and Experiment
with demos
Select Solutions And Apply a Methodology Prepare For the Change Example
1. Strategize
i. Perform Gap analysis
ii. Anticipate future state
iii. Prepare Change Mgmnt
2. Operationalize
i. Create Awareness
ii. Improve Ability
iii. New ways of working
iv. Surveys and feedback
v. KPIs to track progress
3. Implement Changes
i. Pilot Team
ii. New roles
iii. Change Agents & Artifacts
4. Enable Scaling
i. Apply learnings
ii. Scale
iii. Measure & Assess
1. Implement Label Management
System by market - work allocation
2. Involve Global Labelling leads, hub
label managers, Regulatory Affairs
3. Identify the technical gaps in
classifying different requests
4. Consider organizational
responsibilities in work allocation
5. Address process documentation
gaps
6. Develop the training plans for
technology plus process
7. Gather feedback in pilots on
experience and needs
8. Scale and Assess for efficiency,
quality, compliance, timeliness

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6th: Enable Scaling: Measure And Assess
• Efficiencies: resources productivity, cycle time
• Manual Effort
• Reduce Risk: Accuracy and consistency in information
• Quality outputs: First Time Right
Robust management and governance across work streams and regions
Short term
Long term
• Compliance: CCDS – Global à Local; Variations management across the entire
Lifecycle
• Reduction in Health Authority Queries: obviate the obvious
• Faster and accurate closure
• Faster HA Approvals
• Experience improved / Satisfaction: Seamless labeling to artwork communications
• Quality: Error rate, Escalation rate, Rejection rate
• For e.g.; count of supply chain issues due to labeling/artwork concerns/delays

Moving to digital labeling: Journey to achieving Desired Outcomes

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