how to comply with idmp regulatory requirements
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HOW TO COMPLY WITHIDMP REGULATORY REQUIREMENTS
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ABOUT PERFICIENT
Perficient is the leading digital transformation consulting firm serving Global 2000 and
enterprise customers throughout North America.
With unparalleled information technology, management consulting, and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
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PERFICIENT PROFILEFounded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto
Global delivery centers in China and India
>2,800 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
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FEATURED SPEAKERMark ThackstoneSenior Business Consultant• Specializes in the implementation, support, and development of software
used in the collection, management, and analysis of medical product information data
• Expertise in the EVMPD/IDMP arena• Many years of experience working in pharmacovigilance
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AGENDA• A brief history of IDMP• IDMP in Europe
• Timelines and milestones• Is IDMP a problem?• What are the ISO standards?• Where is the data?• Solutions
• Technological aspects• Organizational and project aspects
• A introduction to the Oracle IDMP offering• Summary
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IDMP HISTORY
• Like all problems, started with• “I think things could be better.”
• Since the 80’s – safety databases were growing• MCA/MHRA – Sentinel• FDA AERS• EudraVigilance
• No common standard; meta analysis handicapped by the lack of common standards
• ISO IDMP
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IN EUROPE…• IDMP falls with in a series of initiatives under the
EU Telemetrics Strategy• Other initiatives include management of clinical
trials, monitoring of pharmacovigilance literature, provision of a single portal for drug authorization applications
• IDMP is unique in several ways,• It is multi-disciplinary• It underpins several of the other applications• And it is part of a joint initiative between the
members of the International Conference on Harmonisation (ICH)
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IN EUROPE…• Regulation (EC) No. 726/2004/EU, Article 57 & Regulation (EU) No520/2012 (articles
25 and 26)• Mandated that Marketing Authorisation Holders (MAH) are
required to submit electronically information on all medical products for Human use
• Since 02-Jul-2012 according to a standard described by the EMA – EVMPD
• Since 16-Jun-2014 MAHs needed to update to a new standard– xEVMPD (eXtended EVMPD)
• As of July 2016, MAHs need to move to the next standard• This standard is EVMPD compliant with the relevant
ISO standards• DON’T PANIC – it is accepted that this legal requirement
is unachievable and an incremental plan has been put in place reach the objective
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IN EUROPE…• I won’t say anything about the impact of Brexit!
• Who knows what is going to happen next!!
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SO, WHAT IS IDMP?• EVMPD on Steroids!
• Application of ISO standards to Article 57 product data collection
• This standard was developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. It is one of a group of five standards which together provide the basis for the unique identification of medicinal products.
• It provides data elements and structures for unique identification and exchange
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GOALS OF IDMP• Increased patient safety
• Identification of counterfeit medicines• Enhanced signal detection• Increased transparency
• Increase consistency of the regulation of pharmaceuticals• With in the EU• With the USA (and ultimately other regions that adopt ISO IDMP.
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Industry and Medical Research
Competent Authorities
EXCHANGE AND INTEROPERABILITY
USA FDA EMA
Pharma CompanyRegulators
/ Medicines Agency
Sponsor
Other Stakeholders
Health Service providers –
e.g. NHS
Other Agentse.g. CROs
Assignment of new
substance identifier
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ISO STANDARDSISO 11615
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11240Health informatics — Identification of medicinal products — Data elements and structures for the unique identification
and exchange of units of measurement
ISO 11238Health informatics — Identification of medicinal products — Data elements and structures for the unique identification
and exchange of regulated information on substances
ISO 11616Health informatics — Identification of medicinal products
— Data elements and structures for the unique identification and exchange of regulated pharmaceutical
product information
ISO 11239Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration
and packaging
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ISO STANDARDS
Product Package
ISO 11616regulated pharmaceutical product information
ISO 11615regulated medicinal product
information
ISO 11238substances
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ISO STANDARDS
Product Package
ISO 11239dose forms,
units of presentation, routes of administration
packaging
ISO 11240units of measurement
ISO 11616regulated pharmaceutical product information
ISO 11615regulated medicinal product
information
ISO 11238substances
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IDMPMPID
Version
Medical Product Name
Marketing Authorisation
Marketing Authorisation
Procedure
Manufactoring Authorisation
Holder :Organisation
Holder :Organisation
Regulator : Organisation
Authorisation Authority : OrganisationPCID Outer Packaging Physical Characteristics
Package Item
Package Item Package Item Part Package Item Part
Package Item Part
Substances
Manufactured Item Ingredient Specified Substances
Substances
Substances
StrengthsStrengths
Strengths
Reference Strength
Pharmaceutical Product Ingredient Specified Substances
Substances
Substances
StrengthsStrengths
Strengths
Reference Strength
Route of Administration
Indications
PhPID
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SPOR AND MASTER DATA MANAGEMENT• One thing that is apparent is a large amount of the data is shared or common• Some of these data types are well defined, controlled, and managed in dictionaries
and code lists• MedDRACountry and language lists (ISO 3166 and ISO 639)• International units• ATC
• Where these exist IDMP adopts them
• However what to do about those that are common data points, but are not defined?• This was one of the lessons learned from previous iterations of the Art. 57
database, and the EMA have accepted responsibility for organizing and harmonizing codes for data points such as substances
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SPOR AND MASTER DATA MANAGEMENT
Referencials
Organisation
Products
Substances• Substance - describing the ingredients of a medicine;
• Product - describing the marketing and medicinal information relating to a product;
• Organisation - providing the contact details of organisations and individuals responsible for various aspects of a medicine;
• Referential, providing controlled vocabularies (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) for a medicine, which are explicitly defined for use in Europe.
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TIMELINES AND MILESTONES
• The legal deadline for the move to IDMP is July 2016…but don’t panic!
• Following the experience of the regulators and the industry, this was identified as unachievable
• The EMA has developed as strategy of moving in stages or Iterations
• The first Iteration is planned to kick off in Q2 2018 and become enforceable Q4 2018
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TIMELINES AND MILESTONESRe
fere
ntial
Subs
tanc
es
Products Organizations
Iterations
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TIMELINES AND MILESTONES
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Form
•Paper•Electronic documents•Structured fields
Location
•Regulatory affairs•PV•Sales•Clinical
Repository
•SAS•Spreadsheet•Database
Provenance
•New products•Old products•Legacy products•Authoritative source
IDMP Data
•MPID•PhPID•Substance•Unit
IDMP DATA
All these data attributes have to be taken into consideration
One IDMP record might be made of data elements that come from diverse sources
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Form
•Paper•Electronic documents•Structured fields
Location
•Regulatory affairs•PV•Sales•Clinical
Repository
•SAS•Spreadsheet•Database
Provenance
•New products•Old products•Legacy products
IDMP Data
•MPID•PhPID•Substance•Unit
IDMP DATA
These data points are not static and move within their own quality management systems – the status of the data within the life cycle needs to be considered.
The same data points can also exist in multiple sources, therefore it is necessary to identify the authoritative source, or if you use a secondary source, you need confirmation of its veracity against the primary.
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STRATEGIES AND SOLUTIONS
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DATA HANDLING
DBsDBs
DBs
DBs
DBs
Staging Area
Data Mart
Data Mart
Data Vault
Other Company Purposes
Paper Sources
Data transformed into IDMP
IDMP
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SOLUTION PHASES
Project Plan/ Solution design
Gap Analysis
Data Gathering
Technical solution build and validation
IDMP delivery Maintenance
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FULL PRODUCT LIFE CYCLE - MAINTENANCE
CTA
Withdrawal
MAH
Deve
lopm
ent M
arketed
1. Triggers for a new or updated record?
2. How to make update?
3. QMS?4. Metrics/Oversight
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DBsDBs
DBs
IDMPIDMP Solution
WHERE DO YOU WANT TO END UP?
DBsDBs
DBs
IDMPIDMP Solution
IDMP Solution
DBsDBsDBsIDMP
Master Data Management
Regulatory InformationManagement
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WHERE DO YOU WANT TO END UP?Advantages Disadvantages
Master Data Management
• Possibly faster• Doesn’t require different
departments to change their processes
• Policing the master data• Poor control• Need to maintain multiple
systems
Regulatory Information Management
• Maintenance of a single repository
• Intrinsic master data management
• Inter-departmental inertia• Costly• Potentially slower to deploy• May not meet niche needs
IDMP
IDMP
MDM
RIM
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TEAMS
Design and Build• Existing headcount
• Multi-disciplinary teams• Business SMEs, IT & Project Management• What about their day jobs?
• IDMP-focused teams• Budget• Do you have the necessary expertise?• External support/Consulting
IDMP processing• Extend existing roles
• Training/Procedures • Resource – do you officers have
enough time?• Dedicated IDMP department
LEADERSHIP
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ORACLE OFFERING
Agile OBI
TMSEQD
IDMPEnterprise
Foundation Pack
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SUMMARY• IDMP is the application of ISO standards to the Art 57 (EVMPD) Medical Product
Dictionary• It is a legal requirement in the EU from July 2016, but it is being released in iterations.• Time lines are short and guidance is unclear.• Gap analysis, Data gathering, technical solution design are key early phases for
project success, but don’t lose sight of the long term solution and ensure to factor in the people and procedural component
• Because of the nature of the project – support of senior leadership is critical for success.
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