IDMP update: A practical approach to IDMP implementation ... · PDF fileA practical approach...
Transcript of IDMP update: A practical approach to IDMP implementation ... · PDF fileA practical approach...
Frits Stulp
Managing Director Iperion Life Sciences Consultancy
Samarind Webinar July 29th, 2015
IDMP update:
A practical approach to IDMP implementation and
the impact of the possible new phasing
Introduction
A practical approach to IDMP implementation
The building blocks:
Understanding the impact and recognizing the data
An example: Clinical particulars
Bringing IT together (IT Architecture)
Next steps and the impact of the possible revision in timing
Questions
CONTENTS
INTRODUCTION
Frits Stulp
M.Sc. In Pharmacochemistry
Worked for Yamanouchi / Astellas (1998 – 2007):
Responsible for development and maintenance of R&D Quality System
Manager of European SAP Competence Center / SAP Project Manager
Worked for Accenture (2007 – 2011):
Project manager for several projects in Healthcare and Life Sciences (a.o. Business Intelligence projects, compliance projects)
Independent project manager / advisor since 2011 as Mesa Arch Consulting:
Specialized in project management of IT projects for Regulatory Compliance
Project manager for XEVMPD compliance project for Astellas
Lead consultant and Program Manager for IDMP compliance at Astellas
IDMP SME and practical advisor to MAH’s and Regulatory / PV software suppliers
Active speaker on several IDMP conferences
Managing Director of Iperion Life Sciences Consultancy:
Specialized consulting in (regulatory) compliance in life sciences by applying IT tools (system-agnostic)
INTRODUCTION OF FRITS STULP
COMPANY PROFILE
DEDICATION TO LIFE SCIENCES
SOLUTION PROVIDER
DELIVERY
CHARACTERISTICS
Pharma/Biotech
Medical Devices
Contractors
Health Care
Information Systems
GxP Cloud Comp.
Consultancy
Reliable Solutions
Project Results
High Quality
Customer Satisfaction
CONSULTANCY
Regulatory Affairs (XEVMPD / IDMP)
Quality Management
Computer System Validation Services
IT Compliance & Audits
Consultancy services are based on content knowledge and not
specific or limited to any system or tool
IDMP is mandatory
Need to stay compliant to ensure products on the market
First focus on the EU, but keep in mind the global perspective
IDMP can bring additional benefits to the company
Global identifiers allow for improved communication and
understanding between regions and departments
IDMP
A practical approach to IDMP Implementation: - the building blocks:
Understanding the impact and recognizing the data
An example: Clinical particulars
Bringing IT together (IT Architecture)
IDMP
A DATA EXAMPLE
Manufacturer, the related Operation type and associated
Manufacturing Authorisation number
Where do you record this – in your RIMS, Production system, a
list?
Who is responsible – RA, Manufacturing or QA?
ANOTHER DATA EXAMPLE
Information on the included device with your product:
Like its material and physical characteristics
Where do you keep such data?
The product administered to a patient for treating or preventing disease
Example data: Combined Pharmaceutical Dose Form
Possible sources: Dossier, RIMS
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Medicinal Product
Manu-facturer
Marketing Authori-zation
Packaged Medicinal Product
Pharma-ceutical Product
Clinical Particulars
Information on the manufacturer of the product Example data: Manufacturing License Number Possible sources : RIMS, ERP, Manufacturing information systems, Dossier
The registration and marketing of the product Example data: Marketing Date Possible sources : M&S affiliate, Dossier, RIMS
The Packaging of the product Example data: Image of the packaged product Possible sources : RIMS, ERP, Artwork systems, Manufacturing information systems
Data regarding the manufactured item. Usually this is equal to the Medicinal Product, but there are instances where the product undergoes an transformation before being administered Example data: Strenght of all ingredients
Information about indications, contra-indications, undesirable effects and interactions Example data: Intended Effect
MAPPING THE IDMP DATA TO SOURCES
Medicinal Product
Manufacturer
Marketing Authorization
Packaged Medicinal
Product
Pharma-ceuticalProduct
Clinical Particulars
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Pharma-ceutical Product
Clinical Particulars
Data regarding the manufactured item. Often equal to the Medicinal Product, but product can undergo transformation before being administered Example data: Strength of all ingredients Possible sources: Dossier, RIMS, ERP
Information about indications, contra-indications, undesirable effects and interactions Example data: Intended Effect Possible sources : Dossier, RIMS, Product Information (Systems), SmPC, SPL, Drug safety systems
Substances
Supporting details of substances used Example data: Molecular weight Possible sources : Dossier, RIMS, ERP, SRS ?
MAPPING THE IDMP DATA TO SOURCES
Medicinal Product
Manufacturer
Marketing Authorization
Packaged Medicinal
Product
Pharma-ceuticalProduct
Clinical Particulars
Finding the sources and the impact of IDMP on
your environment:
Find where this data is stored (system, paper, etc.)
Determine specifics for products in scope (devices, biologicals, etc.)
Determine consistency of this information across the globe
Understand the processes & procedures that ensure this data is kept up
to date:
With the up to date regulatory information
With the practice applied in the plant (a.o.)
View the organizational impacts of IDMP
In other words: Do a readiness assessment
UNDERSTANDING IDMP IMPACT
TYPICAL AREAS OF
YOUR ASSESSMENT (1/2)
Regulatory scope
Number of dossiers
Legacy of National Products
eCTD vs pre-eCTD
Global or regional company
Number of license partners and M&A’s
Medical devices in portfolio
Biologicals on the market
Current compliance XEVMPD compliant
SPL compliant
UDI prepared / compliant
Supply chain and manufacturing scope Number of plants
In-house vs contract Manufacturing
TYPICAL AREAS OF
YOUR ASSESSMENT (2/2)
Process maturity
All processes described
Process orientation vs functional (silo) orientation
Procedural arrangements with third parties (e.g. Master data exchange)
IT & architecture Infrastructure for master data mgt
Integration level for applications, like Enterprise service bus and datawarehousing
ERP policy (single instance vs multiple)
Gateway management in place
Labelling solution in place
Organizational readiness
Coverage and detail level of procedures
Establish impact on current roles
Change readiness of involved functions
Some key-factors
can be recognized
that strongly drive
the complexity of
your IDMP
challenge, for
example:
WHAT DRIVES THE OUTCOME?
Decreases complexity
Increases complexity
The outcomes allow you to make your plan and set priorities, naturally, aligned with exernal deadlines and phases.
A practical approach to IDMP Implementation: - the building blocks:
Understanding the impact and recognizing the data
An example: Clinical particulars
Bringing IT together (IT Architecture)
Clinical particulars:
Typically coming from the Product Information documents like
the Summary of Product Characteristics
MedDRA coding is needed when submitting the IDMP records
Although identified in the new phasing as Iteration 3, this
information can have major impact on patient safety and label
consistency
Let’s have a look at some of the fields and where to find them
Then we will see how we can manage this in the SPC and the
IDMP submission at the same time..
AN EXAMPLE
CLINICAL PARTICULARS
IDMP
Clinical Particulars: high level
IDMP
Clinical Particulars: Example
IDMP
Clinical Particulars: Example
IDMP
Clinical Particulars: Example
Coded in MedDRA
PI STRUCTURED AUTHORING
‘Master’ text
‘Instance’ text
‘QRD’ template
PI STRUCTURED AUTHORING
Getting the clinical particulars directly from the SPC
1. Select Clinical Particular(s)
2. Assign Code, via code list
Then clinical particulars can be delivered
as part of the IDMP submission
A practical approach to IDMP Implementation: - the building blocks:
Understanding the impact and recognizing the data
An example: Clinical particulars
Bringing IT together (IT Architecture)
OPTIONS FOR IDMP ARCHITECTURE
Dependent on where your IDMP data is, you can design
your IT architecture, like:
Expand your IDMP data in your RIMS and/or
Manage your source documents (like SPCs)
Bring the data together from the sources
Ensure common terms (= Master data mgt)
And then allow for approval, XML/SPL creation and submission
This can be achieved in all 4 scenarios
IT ARCHITECTURE
NEXT STEPS AND THE IMPACT OF
POSSIBLE REVISION IN TIMING
The official implementation date of 1 July 2016 for the full IDMP
scope is recognized as nearly impossible to achieve
A phased approach to implementation is proposed in which:
Phase 1: limited scope (XEVMPD, substances, mandatory items to
create IDMP identifiers)
Phase 2: scope extended with Investigational Medicinal Products
(development products)
Phase 3: include Clinical Particular details
Phase 4: include batch identifiers, alignment serialization and other
remaining IDMP items
Phase 5: include veterinary products
With initial timelines proposed for late 2017 and later phased up to
2019
HIGH LEVEL FEEDBACK FROM
EMA INFORMATION DAY
ANALYSIS OF ITERATIONS
Iteration 1
Iteration 4
Iteration 4
Iteration 3
Iteration 2
IMPID HIGH LEVEL DATA MODEL
So, the EU ISO IDMP Taskforce has formulated a
phasing plan that:
Is more realistic
Has buy-in from key stakeholders
EMA, NCA’s, Industry, Standardization organizations
But requires approval of the European Commission..
In other words: Be prepared to adjust your IDMP plans to a longer term phasing that fits into your
other RA IT plans
Make sure you can reach this timeline
NEXT STEPS
IDMP is a complicated area and although phasing is being discussed at this
time, you will still need to organize yourself to deal with this by:
Understanding your IDMP Readiness
Incorporating Business and IT alignment in your project
Plan the required project activities, taking relevant phasing and internal
developments into account
Stay tuned to the possible change of timing and take ownership of your
IDMP compliance
There are accelerators out there to help you like:
Project experience, Program templates, Process insights
Let me know if you have any questions!
CLOSING
Contact: Frits Stulp
Managing Director Consultancy
Iperion Life Sciences Consultancy
Phone: +31(0)652727351
Email: [email protected]
Website: www.iperion.nl
LinkedIn: http://www.linkedin.com/pub/frits-stulp/1/aa7/b7b