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W More rapid processes More efficient processes Remove duplication Increase transparency.X-)b)EFPIA IT Proposals 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 initiativesw)EFPIA IT Proposals 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 Proposals The Future for EuropeDossiers 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 systems6mTPmTP,m Networked Review MAA Submission  EFPIA IT Proposals The BenefitsPSingle 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 managementQQPx7EFPIA 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 DirectivesD{3 Yg<Secure Electronic Transmission between 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 EUd@F@E |Static and Dynamic DatauRImplement 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 productsr) ` bbbb`.Establish Dynamic Data Exchange and ManagementDynamic 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,5.c_#!+4-b_#!,mSubmit Updated Parts only @!  ddfnBenefits from PIM qRemoves 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 processesB-ZAZZ-Ae-Submission of ADRs  Implement full production system Engage more agencies Engage more of industry Ensure ICSR activity supported by secure electronic data exchangeB"Z-ZBZ"-BsProcess 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 compatibleB5ZZ4bbb6 WJE @O8EFPIA 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 DirectivesPe 3 eKImplement 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)nGZwZ!ZDZZGw!DaB6Other 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 agencies6ggSingle EU ADR DatabaseHSingle 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 submissionh)>8)>8"EFPIA IT Proposals Conclusions (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`* )Zn"EFPIA IT Proposals Conclusions (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 N;8!! 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