EFPIA IT Proposals
EFPIA Proposals for IT Support to the
European Regulatory Procedures
Mr S. Hasler
EFPIA PAT Regulation 2000
EFPIA IT Proposals 200401.ppt
EFPIA
Slide 1
EFPIA IT Proposals
Key Benefits
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More rapid processes
More efficient processes
Remove duplication
Increase transparency
EFPIA IT Proposals 200401.ppt
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Slide 2
EFPIA IT Proposals
General Principles (1)
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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 Proposals 200401.ppt
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Slide 3
EFPIA IT Proposals
General Principles (2)
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Single standards, in line with ICH,
implemented across Europe
One system across all agencies, wherever
possible
Integrated systems across all agencies,
otherwise
EFPIA IT Proposals 200401.ppt
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Slide 4
EFPIA IT Proposals
The Future for Europe
• Dossiers and data submitted to a single EU
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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
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Slide 5
Networked Review
MAA Submission
Agencies
Applicant
Applicant
MAA
S
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M2
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p
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Approval
M2
Questions
E-mail Link during Assessment
Transparent progress during review
Prepare
e-CTD
EFPIA IT Proposals 200401.ppt
Submit to
EU Network
e-Review
Consolidate
e-Review
Responds to
Questions
Receives
Approval
EFPIA
Slide 6
EFPIA IT Proposals
The Benefits
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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
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Slide 7
EFPIA IT Proposals
Short 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
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Slide 8
Secure Electronic Transmission
between Industry and Agencies
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Implement system supporting
» Secure 2-way transmission of small volumes of
information, e.g.
– variations
– responses
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» Secure 2-way e-mail
Platform underpinning all e-interactions
Eudrasafe?
One system for EU
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Slide 9
Static and Dynamic Data
Static Data
One-off submission
Dynamic Data
Life cycle Management
Growing dossier
CTD
1
1
Regional
Admin
Info
4
Non-Clinical
5
Efficacy
Data
Single EU Repository
EFPIA IT Proposals 200401.ppt
3
Quality
4
Non-Clinical
Implement CTD
5
Clinical
Administrative
Data
Product
Information
3
Quality
Data
5
ADR
data
Database Exchange,
XML Approach
Single EU Database
EFPIA
Slide 10
Implement e-submissions
Stepwise approach using eCTD standards:
• Small dossiers submitted as pdf, e.g. variations
• Establish dynamic data exchange and management
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» continue to support PIM
Implement eCTD for new products
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Slide 11
Establish Dynamic Data Exchange and
Management
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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
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» Administrative data (Module 1)
Provides EU input to evolving eCTD
» PIM included in module 1 of eCTD
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Slide 12
Submit Updated Parts only
Overdose_s
Overdose_s
Overdose_p
Overdose_p
Duration
Duration
Life
Life
XML V 1.0
XML V 1.1
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Slide 13
Benefits from PIM
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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
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Slide 14
e-Submission of ADRs
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Implement full production system
» Engage more agencies
» Engage more of industry
Ensure ICSR activity supported by secure
electronic data exchange
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Slide 15
Process tracking system
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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
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Slide 16
EFPIA IT Proposals
Longer 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
EFPIA IT Proposals 200401.ppt
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Slide 17
Implement eCTD
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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)
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Slide 18
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
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Slide 19
Single EU ADR Database
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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
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Slide 20
EFPIA IT Proposals
Conclusions (1)
• Progress towards future IT implementation
• Realise benefits
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Support EU Expansion
Improve Pharmaco-vigilance system
Bring products more quickly to patients
Enhance competitiveness of EU Regulatory
Procedures
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Slide 21
EFPIA IT Proposals
Conclusions (2)
• Progress towards future IT implementation
• Industry and Agencies work together
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» 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
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Slide 22