EFPIA EFPIA IT Proposals 200401.ppt Slide 1 EFPIA Proposals for IT Support to the European...
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Transcript of EFPIA EFPIA IT Proposals 200401.ppt Slide 1 EFPIA Proposals for IT Support to the European...
EFPIA Slide 1EFPIA IT Proposals 200401.ppt
EFPIA Proposals for IT Support to the European Regulatory Procedures
Mr S. Hasler
EFPIA PAT Regulation 2000
EFPIAEFPIA IT Proposals IT Proposals
EFPIA Slide 2EFPIA IT Proposals 200401.ppt
EFPIA IT ProposalsEFPIA IT ProposalsKey BenefitsKey Benefits
• More rapid processes
• More efficient processes
• Remove duplication
• Increase transparency
EFPIA Slide 3EFPIA IT Proposals 200401.ppt
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 Slide 4EFPIA IT Proposals 200401.ppt
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 Slide 5EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 6EFPIA IT Proposals 200401.ppt
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 Slide 7EFPIA IT Proposals 200401.ppt
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 Slide 8EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 9EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 10EFPIA IT Proposals 200401.ppt
Static and Dynamic Data
1RegionalAdmin
Info
Qua
lity
Ove
rall
Sum
mar
y
Mod
ule
2
Non
-Clin
ical
Ove
rvie
wan
d S
umm
ary
Clin
ical
Ove
rvie
w
Clin
ical
Ove
rvie
w
and
and
Sum
mar
y3
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
Qua
lity
Ove
rall
Sum
mar
yN
on-C
linic
al O
verv
iew
and
Sum
mar
y
Clin
ical
Ove
rvie
w
Clin
ical
Ove
rvie
w
and
and
Sum
mar
y
EFPIA Slide 11EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 12EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 13EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 14EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 15EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 16EFPIA IT Proposals 200401.ppt
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 Slide 17EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 18EFPIA IT Proposals 200401.ppt
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)
EFPIA Slide 19EFPIA IT Proposals 200401.ppt
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
EFPIA Slide 20EFPIA IT Proposals 200401.ppt
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 Slide 21EFPIA IT Proposals 200401.ppt
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 Slide 22EFPIA IT Proposals 200401.ppt
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