Workshop4

EFPIAEFPIA IT Proposals 200401.ppt Slide 1

EFPIA Proposals for IT Support to the European Regulatory Procedures

Mr S. Hasler

EFPIA PAT Regulation 2000

EFPIAEFPIA IT Proposals IT Proposals


EFPIA IT ProposalsEFPIA IT ProposalsKey BenefitsKey Benefits

• More rapid processes

• More efficient processes

• Remove duplication

• Increase transparency


EFPIA IT ProposalsEFPIA IT ProposalsGeneral Principles (1)General Principles (1)

• Intent to remove need for paper copy

• Sufficient IT and business resource committed by agencies and industry

• Collaborative industry/agency approach to agreed initiatives

• Clear benefits for industry and agencies

• Agreed priority order for progression of initiatives


EFPIA IT ProposalsEFPIA IT ProposalsGeneral Principles (2)General Principles (2)

• Single standards, in line with ICH, implemented across Europe

• One system across all agencies, wherever possible

• Integrated systems across all agencies, otherwise


EFPIA IT ProposalsThe Future for Europe

• Dossiers and data submitted to a single EU repository

• e-submissions implemented in support of full lifecycle» eCTD implemented

» eADR submission implemented

» management of static and dynamic data

• Transparent process tracking systems

• Secure email and document exchange systems


Networked ReviewMAA Submission

ApplicantAgencies

Applicant

MAA M2

Single

EU

ReposItory

M2

Approval

Questions

E-mail Link during Assessment

Preparee-CTD

Submit toEU Network e-Review

Consolidatee-Review

Responds toQuestionsReceivesApproval

Transparent progress during review


EFPIA IT ProposalsThe Benefits

• Single set of information for EU decision making

• Supports EU expansion

• Improves Pharmaco-vigilance system

• Bring products more quickly to patients

• Supports single review for Europe

• Improved filing and archiving

• Data integration across product life-cycle

• Improved information sharing and exchange

• Improved tracking and project management


EFPIA IT ProposalsShort Term Initiatives (Before 2002)

• Secure electronic transmission» document exchange» e-mail

• e-Submission of small dossiers

• Management of Dynamic Data - PIM

• e-Submission of ADRs

• Transparent process tracking systems

Support with Appropriate Guidelines and Directives


Secure Electronic Transmission Secure Electronic Transmission between Industry and Agenciesbetween Industry and Agencies

• Implement system supporting» Secure 2-way transmission of small volumes of

information, e.g.– variations– responses

» Secure 2-way e-mail

• Platform underpinning all e-interactions

• Eudrasafe?

• One system for EU


Static and Dynamic Data

1RegionalAdmin

Info

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Quality4

Non-Clinical5

Clinical

CTDCTD

Implement CTDImplement CTD

Dynamic DataDynamic DataLife cycle ManagementLife cycle ManagementGrowing dossierGrowing dossier

Database Exchange,Database Exchange,XML ApproachXML ApproachSingle EU Database Single EU Database

ADRdata

- - AdministrativeAdministrativeDataData

-- ProductProductInformationInformation

QualityQualityDataData

1

3 5

EfficacyData

Static DataStatic DataOne-off submissionOne-off submission

Single EU RepositorySingle EU Repository

Mo

du

le 2

54

Non-Clinical

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Implement e-submissions Implement e-submissions

Stepwise approach using eCTD standards:

• Small dossiers submitted as pdf, e.g. variations

• Establish dynamic data exchange and management» continue to support PIM

• Implement eCTD for new products


Establish Dynamic Data Exchange and Management

• Dynamic data in the dossier to be exchanged» Using defined exchange standard» Database to database

• Potential areas for collaborative initiatives» Management and submission of product information (PIM)» Management and submission of CMC (Module 3)

– Cumulative table of contents– CMC data, starting with small element of data, e.g. specification

» Administrative data (Module 1)

• Provides EU input to evolving eCTD» PIM included in module 1 of eCTD


Submit Updated Parts onlySubmit Updated Parts only

XML V 1.0

Overdose_s

Overdose_p

Life

Duration

XML V 1.1

Overdose_s

Overdose_p

Life

Duration

Overdose_s

Overdose_p

Life

Duration


Benefits from PIM Benefits from PIM

• Removes duplication of work across a product» Creation of documents by applicant» Review of documents by agency

• Brings resource efficiencies

• Reduces number of translations

• Faster notification of changes proposed by agencies or industry

• Capability to support administrative aspects of Decision Making Process and reduce time

• Capability to support MR and National processes


e-Submission of ADRs e-Submission of ADRs

• Implement full production system» Engage more agencies» Engage more of industry

• Ensure ICSR activity supported by secure electronic data exchange


Process tracking systemProcess tracking system

• Implement process tracking system in EU

• Key benefits» Transparent European information» Instant access for industry and regulators to key information

about specific regulatory tasks » Automated process measurement and prompting / alerting of

key dates and milestones» Instant access to the tracking system and information about

own applications» Availability both for the centralised and the mutual recognition

procedures» Different tracking systems implemented at present at a national

level (e.g. MCA's RAMA) made compatible


EFPIA IT ProposalsLonger Term Initiatives (Before 2004)

• Implement eCTD

• Single EU Submission Repository

• Management of Dynamic Data - other dossier components» CMC» Administrative data

• Single EU ADR database

Support with Appropriate Guidelines and Directives


Implement eCTD Implement eCTD

• Implement eCTD as standard for e-submission across product lifecycle:

» When signed off at step 4» Collaboration between agencies and industry» Agencies to develop internal review environments

• Support eCTD with EU legislation» Encouraging e-submission» Removing need for paper copy of submission

• Develop single EU submission repository

• Develop new aspects of eCTD in collaboration with industry (e.g. manage CMC as dynamic data)


Other Benefits of Dynamic Data Exchange and Management

• Dossier content always up-to-date

• Provides transparency of information

• Provides resource savings and efficiencies

• Up-to-date information for better decision making, e.g.» Manufacturing inspections

• Eliminates or speeds up administrative steps

• Tackles common business problem for industry and agencies


Single EU ADR Database

• Single EU repository for product AE data

» Single point of submission

» Single data set for safety profile

• Up-to-date information for better decision making, e.g.

» Protection of public health

• Provides resource savings and efficiencies

• Tackles common business problem for industry and agencies

• Facilitates PSUR creation and submission


EFPIA IT ProposalsConclusions (1)

• Progress towards future IT implementation

• Realise benefits

» Support EU Expansion» Improve Pharmaco-vigilance system» Bring products more quickly to patients» Enhance competitiveness of EU Regulatory

Procedures


EFPIA IT ProposalsConclusions (2)• Progress towards future IT implementation

• Industry and Agencies work together» shared benefits» shared steering committees and task forces

• Require clear commitment to ongoing and future projects» agency business and IT resources

• Support changes with legislation» remove the need for paper

INDUSTRY WILL PLAY OUR PART

Technology

Workshop4