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Dr. Katona Botond AccepTher Ltd. Director, Research and developmet

our xEVMPD solution. Dr. Zajzon Gergely AccepTher Ltd. Director, Business development. Dr. Katona Botond AccepTher Ltd. Director, Research and developmet. Who weare?. our xEVMPD paradigm. xEVMPD compliance. DREAM. IT support for implementation. and system-independent service.

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Dr. Katona Botond AccepTher Ltd. Director, Research and developmet

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  1. our xEVMPD solution Dr. Zajzon Gergely AccepTher Ltd. Director, Business development Dr. Katona Botond AccepTher Ltd. Director, Research and developmet

  2. Who weare? our xEVMPD paradigm xEVMPD compliance DREAM IT support for implementation and system-independent service

  3. WHO WE ARE? • DRUG PRODUCT DEVELOPMENT • overviews, summaries, expert opinions • (…) • development plans • PROJECT MANAGEMENT • product development • clinical development • REGULATORY AFFAIRS • strategic consulting • (…) • local representation • PHARAMCOVIGILANCE • PV system • (…) • local PV tasks • PRICING AND REIMBURSEMENT • CONSULTANCY (HUNGARY) up-to-date knowledge of requirements and INDUSTRIAL AUTHORITY experience, in local and multinational eviromnents

  4. WHO WE ARE? • REGULATORY „IT” • software development • eCTD services • implementation of IT systems • web page design and maintenance • hardver services • REGULATORY ASSISTANCE • PIL redability testing • translations validated and independent Regulatory data and process management SOFTWARE impleneted in both small- and Multinational Pharma environments

  5. OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS EudraVigilance 07.02.

  6. EXAMPLE: HUNGARY OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS – DIVERSITY OF MARKET PLAYERS Distribution of MAs between local market players (excl. representative offices) Distribution of MAHs per number of Mas between local market players (excl. representative offices)

  7. OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS pm gw procedure tracking workflows automated reporting wf compliance & maintenance db

  8. xEVMPD COMPLIANCE DATA COLLECTION AND DATA ENTRY WHICH SET OF DATA? WHERE CAN DATA BE REACHED? pm gw wf automated data entry guided XLS-based data collection public data XSD db manual data entry

  9. EXAMPLES: HANDLING OF CONCENTRATION DATA xEVMPD COMPLIANCE DATA COLLECTION AND DATA ENTRY Example 1: 5,5-5,7 ml/ 100 ml milli liter range 5,5 / milli liter 100 milli liter 5,7 / milli liter 100 Example 2: 10 mg / tablet milli gramm equals 10 / single tablet 1 - - - / - - -

  10. xEVMPD COMPLIANCE REPORTING, HANDLING OF REPORTS according tothe EudraVigilance scheme pm gw wf XSD db

  11. xEVMPD COMPLIANCE REPORTING, HANDLING OF REPORTS

  12. xEVMPD COMPLIANCE REPORTING ABILITY ← VALID DATA ← ADEQUATE WORKFLOW REGULATORY INFORMATION MANAGEMENT • supporting user definitions: use as both a database and a data management system • workflow handling and data access mapping individual responsibility of end-users • Regulatory procedure tracking & xEVMPD feed-back • internal QA compliance • multiple models for xEVMPD reporting

  13. DREAM: Drug Regulatory Electronic Affair Management SYSTEM CHARACTERISTICS AND REQUIREMENTS „THICK CLIENT” • Windows operating system • - MS .Net Framework 3.5 SP1 & 4.0 FILE POOL INTRANET DATABASE - database server (dedicated PC)

  14. DREAM: Drug Regulatory Electronic Affair Management SYSTEM COMPONENTS: MODULARITY D – Drug product database pm gw R – Registry book wf E – Electronic process management A – Audit trail M – Management and reporting X – xEVMPD compliance XSD db S – Support and administration D – Development infomation storage

  15. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  16. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  17. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  18. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  19. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported SSI • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  20. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities; i.e. • - regulatory • - medical

  21. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities: • - regulatory • - medical

  22. DREAM: Drug Regulatory Electronic Affair Management INTERFACE - standard administration and end-user interface - controlled vocabularies a priori enclosed • xEVMPD data structure • compliantProduct Data Sheet • addition of custom fields • supported • prepared for final SSI data • structure • platform-independent document • access • customizable end-user interface • in function of responsibilities: • - regulatory • - medical

  23. DREAM: Drug Regulatory Electronic Affair Management XML-GENERATION AND VALIDATION - according to XSD • According to xEVMPD Business • Rules - validation log, report XML handling ~ workflow - ACK handling

  24. DREAM: Drug Regulatory Electronic Affair Management PROCESS MANAGEMENT • mapping of workflows reaching • accross multiple • organizational units - Regulatory procedure tracking • management of development • processes subject to xEVMPD • reporting • integrated workflows ensuring • xEVMPD otput • (i.e. variation procedures) • custom configuration of workflows • according to pronciples of • project management • (administrator level) to fit actual • daily routine

  25. DREAM: Drug Regulatory Electronic Affair Management EVENT MANAGEMENT • mapping of workflows within • a given organizational unit • platform-independent handling • of enclosures(i.e. PrARs, • other Authority communication) - workflow generation for high- lighted („registered”) events

  26. DREAM: Drug Regulatory Electronic Affair Management DATA MANAGEMENT • product records handling parallels product life- • cycle management • changes of data status handled within • workflows (fool-proof) • data not erased from the datanse upon change • of status or deletion (thief-proof) • data change log (audit-proof) • feature available to the user only in DREAM • implemented as RIMs • DREAM Lite logs data changes in • „background” (invisibly to user) WHY USEFUL? • QPPV oversight • mapping of internal workflows ensuring long-term compliance by autamated control • by the system of the need to generate an XML output

  27. DREAM: Drug Regulatory Electronic Affair Management SUPPORTING LEADERSHIP FUNCTIONS - integrated reporting features • custom reports according to • indivisual needs: supported • („How many of my products • contain lactose?”) • exporting of report • feature available in function of • predefined end-user permission

  28. DREAM: Drug Regulatory Electronic Affair Management QUALITY ASSURANCE COMPLIANCE • developed in line with principles • GAMP5 and 21 CRF part 11 • support for validation in enterprise • environment: • - adaptation to validation criteria • - ensuring required documents • - operational presence • - consultancy • end-user application: • - algorithmic(SOP • suitability) • - adaptability to procedures in • place • - end-user activity log - support for establishment of SOPs

  29. DREAM: Drug Regulatory Electronic Affair Management BENEFITS OF A DREAM D – Data safety pm gw R – Robustness of the IT platform wf E – Ease to implement A – Adaptability M – Multi-level user definition X – eXpertise and eXperience XSD db S – Service only as needed D – Dynamic models for compliance

  30. DREAM: Drug Regulatory Electronic Affair Management TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION 2001 EudraVigilance 2005 First RIMs live (MS-Access ) 2008.12 EU RDM v 2.0 DREAM release 1.0 live 2009.07 DREAM: CT module live(CTA) 2010.12 Directive 2010/84/EU Regulation 1235/2010 DREAM: PV module live (PSUR, CIOMS) 2011.07 Art 57(2) Legal notice DREAM: 7x 2011.09 xEVMPD guidance 2.0 DREAM Lite – xEVMPD (1) 2012.03 xEVMPD guidance 3.0 NOT NECESSARILY RELATED TO THE xEVMPD DEADLINE! DREAM release2.0 2012.04 FileFlowergateway Userspecification 2 mo 2012.07 xEVMPD deadline Data ”migration”, config.s Operational implementation xEVMPD guidance 4.0 (SSI) ? + 3 hó DREAM / DREAM Lite – xEVMPD (2)

  31. FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK SYSTEM IMPLEMENTATION AND MAINTENANCE SaaS: USER SPECIFICATION !!! • system set-up, configuration of the • database and end-user permissions • adaptation of the database according to the • enterprise infrastructure, if an IT policy • support in data „migration”(i.e. XLS, other • databases), adapted to internal QA • requirements • user manula and training • consultancy for establishment or update of • SOPs, as required • maintenance service: option, not a must! • (administrator know-how-t transferred!) • on-demand post-implementation availability

  32. FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK xEVMPD SERVICES Data collection & data entry MedDRA coding of indications Databasemaintenance xEVMPD compliance Consultancy

  33. 1024, Budapest, Ady Endre u. 22. 2000, Szentendre, Nap u. 52/21 soldra@soldra.com contact@accepther.com THNANK YOU FOR YOUR INTEREST AND ATTENTION! www.xEVMPD.hu

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