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  1. 1. EFPIA Proposals for IT Support to the European Regulatory Procedures Mr S. Hasler EFPIA PAT Regulation 2000 Slide EFPIA IT Proposals
  2. 2. EFPIA IT Proposals Key Benefits <ul><li>More rapid processes </li></ul><ul><li>More efficient processes </li></ul><ul><li>Remove duplication </li></ul><ul><li>Increase transparency </li></ul>Slide
  3. 3. EFPIA IT Proposals General Principles (1) <ul><li>Intent to remove need for paper copy </li></ul><ul><li>Sufficient IT and business resource committed by agencies and industry </li></ul><ul><li>Collaborative industry/agency approach to agreed initiatives </li></ul><ul><li>Clear benefits for industry and agencies </li></ul><ul><li>Agreed priority order for progression of initiatives </li></ul>Slide
  4. 4. EFPIA IT Proposals General Principles (2) <ul><li>Single standards, in line with ICH, implemented across Europe </li></ul><ul><li>One system across all agencies, wherever possible </li></ul><ul><li>Integrated systems across all agencies, otherwise </li></ul>Slide
  5. 5. EFPIA IT Proposals The Future for Europe <ul><li>Dossiers and data submitted to a single EU repository </li></ul><ul><li>e-submissions implemented in support of full lifecycle </li></ul><ul><ul><li>eCTD implemented </li></ul></ul><ul><ul><li>eADR submission implemented </li></ul></ul><ul><ul><li>management of static and dynamic data </li></ul></ul><ul><li>Transparent process tracking systems </li></ul><ul><li>Secure email and document exchange systems </li></ul>Slide
  6. 6. Networked Review MAA Submission Slide Applicant Agencies Applicant MAA M2 S i n g l e E U R e p o s I t o r y M2 Approval Questions E-mail Link during Assessment Prepare e-CTD Submit to EU Network e-Review Consolidate e-Review Responds to Questions Receives Approval Transparent progress during review
  7. 7. EFPIA IT Proposals The Benefits <ul><li>Single set of information for EU decision making </li></ul><ul><li>Supports EU expansion </li></ul><ul><li>Improves Pharmaco-vigilance system </li></ul><ul><li>Bring products more quickly to patients </li></ul><ul><li>Supports single review for Europe </li></ul><ul><li>Improved filing and archiving </li></ul><ul><li>Data integration across product life-cycle </li></ul><ul><li>Improved information sharing and exchange </li></ul><ul><li>Improved tracking and project management </li></ul>Slide
  8. 8. EFPIA IT Proposals Short Term Initiatives (Before 2002) <ul><li>Secure electronic transmission </li></ul><ul><ul><li>document exchange </li></ul></ul><ul><ul><li>e-mail </li></ul></ul><ul><li>e-Submission of small dossiers </li></ul><ul><li>Management of Dynamic Data - PIM </li></ul><ul><li>e-Submission of ADRs </li></ul><ul><li>Transparent process tracking systems </li></ul><ul><li>Support with Appropriate Guidelines and Directives </li></ul>Slide
  9. 9. Secure Electronic Transmission between Industry and Agencies <ul><li>Implement system supporting </li></ul><ul><ul><li>Secure 2-way transmission of small volumes of information, e.g. </li></ul></ul><ul><ul><ul><li>variations </li></ul></ul></ul><ul><ul><ul><li>responses </li></ul></ul></ul><ul><ul><li>Secure 2-way e-mail </li></ul></ul><ul><li>Platform underpinning all e-interactions </li></ul><ul><li>Eudrasafe? </li></ul><ul><li>One system for EU </li></ul>Slide
  10. 10. Static and Dynamic Data Slide 1 Regional Admin Info Quality Overall Summary Non-Clinical Overview and Summary Clinical Overview and Summary 3 Quality 4 Non-Clinical 5 Clinical CTD Implement CTD Module 2 Dynamic Data Life cycle Management Growing dossier Database Exchange, XML Approach Single EU Database ADR data - Administrative Data - Product Information Quality Data 1 3 5 Efficacy Data Static Data One-off submission Single EU Repository Module 2 5 4 Non-Clinical Quality Overall Summary Non-Clinical Overview and Summary Clinical Overview and Summary
  11. 11. Implement e-submissions <ul><li>Stepwise approach using eCTD standards: </li></ul><ul><li>Small dossiers submitted as pdf, e.g. variations </li></ul><ul><li>Establish dynamic data exchange and management </li></ul><ul><ul><li>continue to support PIM </li></ul></ul><ul><li>Implement eCTD for new products </li></ul>Slide
  12. 12. Establish Dynamic Data Exchange and Management <ul><li>Dynamic data in the dossier to be exchanged </li></ul><ul><ul><li>Using defined exchange standard </li></ul></ul><ul><ul><li>Database to database </li></ul></ul><ul><li>Potential areas for collaborative initiatives </li></ul><ul><ul><li>Management and submission of product information (PIM) </li></ul></ul><ul><ul><li>Management and submission of CMC (Module 3) </li></ul></ul><ul><ul><ul><li>Cumulative table of contents </li></ul></ul></ul><ul><ul><ul><li>CMC data, starting with small element of data, e.g. specification </li></ul></ul></ul><ul><ul><li>Administrative data (Module 1) </li></ul></ul><ul><li>Provides EU input to evolving eCTD </li></ul><ul><ul><li>PIM included in module 1 of eCTD </li></ul></ul>Slide
  13. 13. Submit Updated Parts only Slide 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
  14. 14. Benefits from PIM <ul><li>Removes duplication of work across a product </li></ul><ul><ul><li>Creation of documents by applicant </li></ul></ul><ul><ul><li>Review of documents by agency </li></ul></ul><ul><li>Brings resource efficiencies </li></ul><ul><li>Reduces number of translations </li></ul><ul><li>Faster notification of changes proposed by agencies or industry </li></ul><ul><li>Capability to support administrative aspects of Decision Making Process and reduce time </li></ul><ul><li>Capability to support MR and National processes </li></ul>Slide
  15. 15. e-Submission of ADRs <ul><li>Implement full production system </li></ul><ul><ul><li>Engage more agencies </li></ul></ul><ul><ul><li>Engage more of industry </li></ul></ul><ul><li>Ensure ICSR activity supported by secure electronic data exchange </li></ul>Slide
  16. 16. Process tracking system <ul><li>Implement process tracking system in EU </li></ul><ul><li>Key benefits </li></ul><ul><ul><li>T ransparent European information </li></ul></ul><ul><ul><li>I nstant access for industry and regulators to key information about specific regulatory tasks </li></ul></ul><ul><ul><li>A utomated process measurement and prompting / alerting of key dates and milestones </li></ul></ul><ul><ul><li>I nstant access to the tracking system and information about own applications </li></ul></ul><ul><ul><li>Availability both for the centralised and the mutual recognition procedures </li></ul></ul><ul><ul><li>D ifferent tracking systems implemented at present at a national level (e.g. MCA's RAMA) made compatible </li></ul></ul>Slide
  17. 17. EFPIA IT Proposals Longer Term Initiatives (Before 2004) <ul><li>Implement eCTD </li></ul><ul><li>Single EU Submission Repository </li></ul><ul><li>Management of Dynamic Data - other dossier components </li></ul><ul><ul><li>CMC </li></ul></ul><ul><ul><li>Administrative data </li></ul></ul><ul><li>Single EU ADR database </li></ul><ul><li>Support with Appropriate Guidelines and Directives </li></ul>Slide
  18. 18. Implement eCTD <ul><li>Implement eCTD as standard for e-submission across product lifecycle: </li></ul><ul><ul><li>When signed off at step 4 </li></ul></ul><ul><ul><li>Collaboration between agencies and industry </li></ul></ul><ul><ul><li>Agencies to develop internal review environments </li></ul></ul><ul><li>Support eCTD with EU legislation </li></ul><ul><ul><li>Encouraging e-submission </li></ul></ul><ul><ul><li>Removing need for paper copy of submission </li></ul></ul><ul><li>Develop single EU submission repository </li></ul><ul><li>Develop new aspects of eCTD in collaboration with industry (e.g. manage CMC as dynamic data) </li></ul>Slide
  19. 19. Other Benefits of Dynamic Data Exchange and Management <ul><li>Dossier content always up-to-date </li></ul><ul><li>Provides transparency of information </li></ul><ul><li>Provides resource savings and efficiencies </li></ul><ul><li>Up-to-date information for better decision making, e.g. </li></ul><ul><ul><li>Manufacturing inspections </li></ul></ul><ul><li>Eliminates or speeds up administrative steps </li></ul><ul><li>Tackles common business problem for industry and agencies </li></ul>Slide
  20. 20. Single EU ADR Database <ul><li>Single EU repository for product AE data </li></ul><ul><ul><li>Single point of submission </li></ul></ul><ul><ul><li>Single data set for safety profile </li></ul></ul><ul><li>Up-to-date information for better decision making, e.g. </li></ul><ul><ul><li>Protection of public health </li></ul></ul><ul><li>Provides resource savings and efficiencies </li></ul><ul><li>Tackles common business problem for industry and agencies </li></ul><ul><li>Facilitates PSUR creation and submission </li></ul>Slide
  21. 21. EFPIA IT Proposals Conclusions (1) <ul><li>Progress towards future IT implementation </li></ul><ul><li>Realise benefits </li></ul><ul><ul><li>Support EU Expansion </li></ul></ul><ul><ul><li>Improve Pharmaco-vigilance system </li></ul></ul><ul><ul><li>Bring products more quickly to patients </li></ul></ul><ul><ul><li>Enhance competitiveness of EU Regulatory Procedures </li></ul></ul>Slide
  22. 22. EFPIA IT Proposals Conclusions (2) <ul><li>Progress towards future IT implementation </li></ul><ul><li>Industry and Agencies work together </li></ul><ul><ul><li>shared benefits </li></ul></ul><ul><ul><li>shared steering committees and task forces </li></ul></ul><ul><li>Require clear commitment to ongoing and future projects </li></ul><ul><ul><li>agency business and IT resources </li></ul></ul><ul><li>Support changes with legislation </li></ul><ul><ul><li>remove the need for paper </li></ul></ul><ul><li>INDUSTRY WILL PLAY OUR PART </li></ul>Slide