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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