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Confidential - Property of Navitas - 2015
IDMP - IDentification of Medicinal Products
From concept to reality
31 March, 2016
Rens
van den Boomen
Presented by
Navitasnets host live webcast events
Confidential - Property of Navitas - 2015
2
Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
3
ISO IDMP is a global standard, with EMA and EU NCAs
as early adopters
It is an ISO Standard (163 members)
ISO member countries with a national standards body and ISO voting rights
Correspondent members (countries without a national standards body)
Subscriber members (countries with small economies)
IDMP
Confidential - Property of Navitas - 2015
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IDMP data describes what a product is, where it is
authorised, how it looks, and where its parts come from
Ingredients & Substances
Ingredients
Substances
Strengths
Medicinal Product
Name
Identification
Classification
Market Authorisations
Marketing Approvals
Legal status
Countries
Manufacturing
Organisations
Operation Types
Identification
Packaging
Container
Packed Items
Clinical Particulars
Therapeutic indication
Undesired effects
Contraindications
Pharmaceutical Particulars
Dosage form
Route of admin
Units of presentation
IDMP
243data points
Confidential - Property of Navitas - 2015
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IDMP introduces unique IDs at every stage of the supply
chain for full traceability and transparency
RMs IMs FGs
MFG Primary
Packaging
2ndary
Packaging
Distribution
NetworksHCPs &
Patients
Components
BAID_2
API
Excipient
BAID_1
PCID
PHPID
MPID
SID
Confidential - Property of Navitas - 2015
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EMA has published and extended the timeline for IDMP
implementation in alignment with their SPOR initiative
Source: Minutes of EU ISO IDMP Task Force meeting 19 February 2016 -
http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2016/03/WC500203327.pdf
Confidential - Property of Navitas - 2015
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IDMP key regulatory messages
Timeline for P&S it. 01 has been moved forward to a later date with approx.
9 months
Publication of EU IGs moved from H2 2016 Q1/Q2 2017
Kick off P&S it. 01 moved from Q1 2017 Q1/Q2 2018
Enforcement of P&S it. 01 moved from Q2 2018 Q3/Q4 2018
Product it. 02 not mentioned in updated timeline
Number of data attributes for it. 01 slightly reduced
2016 is all about:
controlled vocabularies, operating models for CVs, unique IDs and exchange of
product information, technical specifications and finalisation of IGs
Our advice:
Disconnect yourself (slightly) from EMA timelines and associate IDMP implementation to
solving a real-time business challenge
Confidential - Property of Navitas - 2015
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Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
9
Today, wherever a product is released into the market
the approved label requires to be in complete alignment
Compliance
“Today”
=Product
Released
Approved
Label
Region/Country
MAH
Confidential - Property of Navitas - 2015
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In the future the approved IDMP data set (snapshot) for
each of those markets is to be included into this mix
Region/Country
MAH
=
Product
Released
Approved
IDMP SetApproved
Label
Compliance
“Today” “Future”
=Product
Released
Approved
Label
Region/Country
MAH
Confidential - Property of Navitas - 2015
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Today global operating company have to maintain hundreds of
labels plus deviations for every market release
X times # of registrations and packs per market
Confidential - Property of Navitas - 2015
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On top of that, with the introduction of IDMP, global operating
companies have to maintain IDMP snapshots for each market
X times # of registrations and packs per market
Confidential - Property of Navitas - 2015
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How do you ensure full control of your product releases,
labels and IDMP data sets on a global scale?
MAH
“Compliance”
Confidential - Property of Navitas - 2015
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Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
15
SmPC, PIL, PSUR, PBRER etc. are an integrated part of the IDMP
data set
This means:
1. Changes to these documents
equals a change to IDMP data sets
2. Both are version controlled and
need to remain uniquely linked
together
SmPC
PIL
PSUR /
PBRER
…
ISO 11615 sec 3.1.72:
any document issued by a Medicines Regulatory Agency in
the context of the regulatory process to grant, maintain or
update the authorization of a Medicinal Product or in the
regulatory process of the authorization and supervision of
clinical trials
Confidential - Property of Navitas - 2015
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All product information used in those documents are
detangled and part of the structured IDMP data model
Confidential - Property of Navitas - 2015
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This allows you to make IDMP an integrated part of your
change control and associated labelling processes
Submission to NCA
Submission to EMA
IDMP Process
Labelling Process
Business Processes
Data Management Processes
Exchange of Product InformationTrigger
(Change Control)
IDMP Submissions
Label submissions
Submission Processes
∆ discrepancies equal questions from regulators
Confidential - Property of Navitas - 2015
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Change Control Process
Submission processes
Label business processes
IDMP data management processes
IDMP data management will accelerate the labelling process,
allow for tighter change control and IDMP compliance reporting
Auto-Reports
SmPC
PIL
PSUR / PBRER
IDMP submission
Pre-population of Regulatory documents
Author finalising the
label for submission
Manual Authoring
System
Updated label
Trigger:
Label Change
Change
owner
,,,
Author(s)IDMP Impact Assessment
Update/build IDMP record(s)
Functional
SMEs
IDMP change
owner
Times x registrations impacted
Review/approve changes
IDMP
approver
Label / IDMP Submissions
Submission
Owner
IDMP submission
Report
Confidential - Property of Navitas - 2015
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Benefits
Improved patient safety
Reduced lead times to bring critical safety information into the market place
Acceleration of labelling process
Reduction of lead-times, handovers and forms to be used
Auto population of key regulatory documents (SmPC, PIL, PSURs, etc.)
eLabelling and E2E tracking of Risk Minimisation Measures
Standardisation of structured product information
Precursor for business analytics/big data
Part of master data initiatives and data integration
IDMP compliance
Improved brand protection
Confidential - Property of Navitas - 2015
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Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
21
The journey from a decision to change the label to release in
market is long and requires tracking and tight control
Multiple Years
Timeline 1 – Variation A / Deviation X
Timeline 2 – Variation B / Deviation Y
Timeline 3 – Variation C / Deviation Z
etc…
Supply Chain
Implementation
Health
Authority
negotiation
Preparation
and dispatch
of core
submission
pack
Confirm
need
for label
change
Translation
and local
submission
Management
& tracking
of Deviations
Artwork
preparation
Update product
info in public
domain
Safety changes
New products
Technical
changes
Non-safety /
other changes
Label in
market
Confidential - Property of Navitas - 2015
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If tracking would be done today, we need to map and link
up existing identifiers between processes and systems
SKU 1
SKU 2
Change Control
Registration Database
Artwork BOM Batch Records
CR #
MA #
Art ID 1
Art ID 2
MA Pack 1
MA Pack 2
Batch #
SKU
BOM 1
BOM 2
Batch #
QMS
RIMS
ArtworkRIMS
DMS
ERP
1..*
1..*
1..*
1..*
Pro
ced
ure
sU
niq
ue
Iden
tifi
ers
Supply Chain
Implementation
Health
Authority
negotiation
Preparation
and dispatch
of core
submission
pack
Confirm
need
for label
change
Translation
and local
submission
Management
& tracking
of Deviations
Artwork
preparation
Update product
info in public
domain
Safety changes
New products
Technical
changes
Non-safety /
other changes
Label in
market
Raise CR
Close CR
Confidential - Property of Navitas - 2015
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IDMP unique IDs
Serialisation
IDMP introduces IDs at every stage of the supply chain;
Serialisation introduces traceability in the distribution network
Confidential - Property of Navitas - 2015
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Serialisation together with IDMP enables E2E tracking of
safety measures and associated label changes
Supply Chain
Implementation
Health
Authority
negotiation
Preparation
and dispatch
of core
submission
pack
Confirm
need
for label
change
Translation
and local
submission
Management
& tracking
of Deviations
Artwork
preparation
Update product
info in public
domain
Safety changes
New products
Technical
changes
Non-safety /
other changes
Label in
market
Pro
ced
ure
s
Raise CR
IDMP (July 2016 onwards)
Serialisation* (2017 & Feb 2019)
PCID
MPID
GTIN
CR#
BAID(2)
Un
iqu
e
Iden
tifi
ers
Registration Level
Package Registration Level
Individual Pack Level
1..*
1..*
1..*
1..*
*Global Trade Identification Number
*US: Drug Supply Chain Security Act (2017)EU: Falsified medicine Act (2019)
Change Control
Close CR
SN1..*
Batch #1..*
Confidential - Property of Navitas - 2015
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Data carriers (i.e. GTIN) are an integrated part of the
IDMP data model
Packaged Item Container
Packaged Medicinal Product
Data Carrier Identifier
GTIN
PCID
Medicinal Product
MPID
1..*
1..*
0..*
11615
BatchIdentifier
BAID(2)
0..*
(Outer Package)
Split into individual components
Confidential - Property of Navitas - 2015
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IDMP compliance means being in full control of your product
information for any product released in any market
Oversight
Build, manage and maintain IDMP content
including regulatory documents
corresponding to deviating market
requirements
Proactive management of workload and QC
of IDMP records throughout the building,
submission as well as product release
phases
Transparency
Ability to track the deviations and decisions
corresponding to them
Version control and information retention
Traceability
Ability to extract/maintain tracking information
of key E2E tracking points with introduction
of IDMP unique IDs and Serialisation
=
Product
Released
Approved
IDMP SetApproved
Label
Transparency
Confidential - Property of Navitas - 2015
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Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
28
Navitas would like to facilitate a xNetworks IDMP
working group
What would you get out of it (purpose)?Topic examples could include:
Labelling & Serialisation
Regulatory documents (SmPc, PIL, PSUR, PBRER, etc.)
Pharmacovigilance (E2B_R3, commitment tracking, etc.)
Product Quality Complaints
…
Exact purpose will be established by its member during first call
Solution orientated, best practices, driving business improvements
How would we work (commitment)?Teleconference (every 1 or 2 months)
Work packages, supported by Navitas SMEs
F2F breakout sessions during forums
Interested?Please send an email to [email protected]
Confidential - Property of Navitas - 2015
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Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
30
Upcoming 2016 Navitasnets Spring Forum dates
Network
Spring Dates 2016Timings 09.30 – 16.30
New York London
14 June – forum
13 June - HoS21 June
16 June 23 June
15 June 22 June
15 - 16 June 24 May
14 June 25 May
Early June /
NEW! 15 June /CDS
RoundTable
Confidential - Property of Navitas - 2015
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2016/7 will see the continuation of quarterly webcasts to
hear the latest best practice
Latest Regulatory context for
IDMP
IDMP – 5 steps to success
Maturity assessment
Strategy roadmap
Program management
System implementation
IDMP deployment
Case study – tbc?
Where next
A reminder of why E2E tracking
is key
Regulatory scrutiny / E2E
model
The start and end point of
labelling
Key milestones, timelines,
interfaces
Tracking tools in action
A portfolio of tools
Success stories
Preventing pitfalls ,
Reaping benefit
Looking forward
IDMP
From concept to reality
31st March 2016
Global PV connections
Managing across borders
18th Feb 2016
Navitasnets host live webcast events
The shifting global PV context
Shifting regs, Complex landscape
Rising volumes , headcount sqeeze
Building global connections
Managing across borders –
affiliates, partners
Assessing risk and resource needs
Strategies for success
Governance in action
Success stories (case stud
examples
Preventing pitfalls , Reaping benefit
Looking forward?
E2E labelling
“Tracking tools in action”
14th April 2016
Confidential - Property of Navitas - 2015
32
Agenda
IDMP concepts and regulatory update
IDMP compliance, what does it mean?
IDMP and labelling
IDMP and Serialisation
Introducing the IDMP xNetworks working group
Next Navitas webinars & forums
Q&A
Confidential - Property of Navitas - 2015
34
Thank you for listening
M: +44 (0) 7766 107514
USANavitas Inc.
502 Carnegie Center
Suite 100, Princeton,
NJ 08540, USA
Tel: +1 609 720 1002
EUNavitas Life Sciences Limited
Parklands Business Park,
Forest Road, Denmead
Hampshire, PO7 6XP, UK
Tel: +44 (0) 2392 268133
IndiaNavitas LLP
2nd Floor, Block – A1
Shriram “The Gateway SEZ”
No. 16, GST Road, Perungalathur
Chennai-600063, India
NJ 08540
Tel: +91 44 4590 9000
www.navitas.net