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

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Presentation on theme: "Dr. Katona Botond AccepTher Ltd. Director, Research and developmet our xEVMPD solution Dr. Zajzon Gergely AccepTher Ltd. Director, Business development."— Presentation transcript:

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

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

3 - 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) INDUSTRIALAUTHORITY up-to-date knowledge of requirements and experience, in local and multinational eviromnents WHO WE ARE?

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

5 EudraVigilance UNITY OF REGULATORY REQUIREMENTS OUR xEVMPD PARADIGM

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

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

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

9 EXAMPLES: HANDLING OF CONCENTRATION DATA Example 1: 5,5-5,7 ml/ 100 ml range5,5 milliliter / 100 milliliter 5,7 milliliter / 100 milliliter Example 2: 10 mg / tablet equals10 milligramm / 1 singletablet - -- / - -- xEVMPD COMPLIANCE DATA COLLECTION AND DATA ENTRY

10 REPORTING, HANDLING OF REPORTS gwpm wf db according to the EudraVigilance scheme XSD xEVMPD COMPLIANCE

11 REPORTING, HANDLING OF REPORTS xEVMPD COMPLIANCE

12 REPORTING ABILITY ← VALID DATA ← ADEQUATE WORKFLOW xEVMPD COMPLIANCE - 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 REGULATORY INFORMATION MANAGEMENT

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

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

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

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

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

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

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

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

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

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

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

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

26 DATA MANAGEMENT DREAM: Drug Regulatory Electronic Affair Management - product records handling parallels product life- cycle management - feature available to the user only in DREAM implemented as RIMs -DREAM Lite logs data changes in „background” (invisibly to user) - mapping of internal workflows ensuring long-term compliance by autamated control by the system of the need to generate an XML output - QPPV oversight - 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) WHY USEFUL?

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

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

30 TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION DREAM: Drug Regulatory Electronic Affair Management Directive 2010/84/EU Regulation 1235/ First RIMs live (MS-Access ) DREAM release 1.0 live DREAM: CT module live (CTA) DREAM: PV module live (PSUR, CIOMS) Art 57(2) Legal notice xEVMPD guidance 2.0 DREAM: 7x xEVMPD guidance xEVMPD deadline ? xEVMPD guidance 4.0 (SSI) + 3 hó DREAM release DREAM / DREAM Lite – xEVMPD (2) User specification Data ”migration”, config.s Operational implementation 2 mo EU RDM v EudraVigilance FileFlower gateway DREAM Lite – xEVMPD (1) NOT NECESSARILY RELATED TO THE xEVMPD DEADLINE!

31 SYSTEM IMPLEMENTATION AND MAINTENANCE FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK - 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 SaaS: USER SPECIFICATION !!!

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

33 2000, Szentendre, Nap u. 52/ , Budapest, Ady Endre u. 22. THNANK YOU FOR YOUR INTEREST AND ATTENTION!


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