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our xEVMPD solution Dr. Zajzon Gergely Dr. Katona Botond

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Presentation on theme: "our xEVMPD solution Dr. Zajzon Gergely Dr. Katona Botond"— Presentation transcript:

1 our xEVMPD solution Dr. Zajzon Gergely Dr. Katona Botond
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 PROJECT MANAGEMENT
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 UNITY OF REGULATORY REQUIREMENTS
OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS EudraVigilance 07.02.

6 UNITY OF REGULATORY REQUIREMENTS – DIVERSITY OF MARKET PLAYERS
OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS – DIVERSITY OF MARKET PLAYERS EXAMPLE: HUNGARY 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 UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS
OUR xEVMPD PARADIGM UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS pm gw procedure tracking workflows automated reporting wf compliance & maintenance db

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

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

11 xEVMPD COMPLIANCE REPORTING, HANDLING OF REPORTS

12 REPORTING ABILITY ← VALID DATA ← ADEQUATE WORKFLOW
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 compliant Product 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 compliant Product 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 compliant Product 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 compliant Product 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 SSI DREAM: Drug Regulatory Electronic Affair Management INTERFACE
- standard administration and end-user interface - controlled vocabularies a priori enclosed xEVMPD data structure compliant Product 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 compliant Product 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 compliant Product 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 compliant Product 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 XML beküldés munkafolyamat – több modellt dolgoztunk ki: adatfeltöltés / validálás // workflow-ba is illeszthető / gateway használat esetén eltérő modell // termékenkéénti beküldés // csoportos (batch) beküldés; ACK kezelése => EVCODE-k visszaírása // Post esetén kézi Ack - 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 NOT NECESSARILY RELATED TO THE
DREAM: Drug Regulatory Electronic Affair Management TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION 2001 EudraVigilance 2005 First RIMs live (MS-Access ) EU RDM v 2.0 DREAM release 1.0 live DREAM: CT module live (CTA) Directive 2010/84/EU Regulation 1235/2010 DREAM: PV module live (PSUR, CIOMS) Art 57(2) Legal notice xEVMPD guidance 2.0 DREAM: 7x xEVMPD guidance 3.0 DREAM Lite – xEVMPD (1) NOT NECESSARILY RELATED TO THE xEVMPD DEADLINE! DREAM release 2.0 FileFlower gateway User specification 2 mo xEVMPD deadline Data ”migration”, config.s ? xEVMPD guidance 4.0 (SSI) Operational implementation + 3 hó DREAM / DREAM Lite – xEVMPD (2)

31 SaaS: USER SPECIFICATION !!!
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 Database maintenance xEVMPD compliance Consultancy

33 THNANK YOU FOR YOUR INTEREST
1024, Budapest, Ady Endre u. 22. 2000, Szentendre, Nap u. 52/21 THNANK YOU FOR YOUR INTEREST AND ATTENTION!


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