dr. katona botond accepther ltd. director, research and developmet our xevmpd solution dr. zajzon...
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![Page 1: Dr. Katona Botond AccepTher Ltd. Director, Research and developmet our xEVMPD solution Dr. Zajzon Gergely AccepTher Ltd. Director, Business development](https://reader035.vdocuments.mx/reader035/viewer/2022062423/56649ccf5503460f9499a98b/html5/thumbnails/1.jpg)
Dr. Katona BotondAccepTher Ltd.Director, Research and developmet
our xEVMPD solution
Dr. Zajzon GergelyAccepTher Ltd.Director, Business development
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Who weare?
our xEVMPD paradigm
xEVMPD compliance
DREAM
IT support for implementationand system-independentservice
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- 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)
INDUSTRIAL AUTHORITY
up-to-date knowledge of requirementsand
experience, in local andmultinational eviromnents
WHO WE ARE?
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- 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 independentRegulatory data and process management
impleneted in both small- and Multinational Pharma environments
WHO WE ARE?
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EudraVigilance
UNITY OF REGULATORY REQUIREMENTS
OUR xEVMPD PARADIGM
07.02.
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Distribution of MAsbetween local market players(excl. representative offices)
Distribution of MAHs per number of Masbetween local market players(excl. representative offices)
UNITY OF REGULATORY REQUIREMENTS – DIVERSITY OF MARKET PLAYERS
OUR xEVMPD PARADIGM
EXAMPLE: HUNGARY
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compliance &maintenance
procedure trackingworkflows
automated reporting
db
gwpm
wf
UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS
OUR xEVMPD PARADIGM
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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
dbXSD
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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
- - - / - - -
xEVMPD COMPLIANCE
DATA COLLECTION AND DATA ENTRY
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REPORTING, HANDLING OF REPORTS
gwpm
wf
db
according to theEudraVigilance scheme
XSD
xEVMPD COMPLIANCE
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REPORTING, HANDLING OF REPORTS
xEVMPD COMPLIANCE
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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
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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
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SYSTEM COMPONENTS: MODULARITY
DREAM: Drug Regulatory Electronic Affair Management
gwpm
wf
dbXSD
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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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?
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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
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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
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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
dbXSD
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TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION
DREAM: Drug Regulatory Electronic Affair Management
2010.12 Directive 2010/84/EURegulation 1235/2010
2005 First RIMs live (MS-Access )
2008.12 DREAM release 1.0 live
2009.07 DREAM: CT module live (CTA)
2011.07
DREAM: PV module live (PSUR, CIOMS)
Art 57(2) Legal notice
2011.09 xEVMPD guidance 2.0 DREAM: 7x
2012.03 xEVMPD guidance 3.0
2012.07 xEVMPD deadline
? xEVMPD guidance 4.0 (SSI)+ 3 hó
DREAM release 2.0
2012.04
DREAM / DREAM Lite – xEVMPD (2)
User specification
Data ”migration”, config.sOperational implementation
2 mo
EU RDM v 2.0
2001 EudraVigilance
FileFlower gateway
DREAM Lite – xEVMPD (1)NOT NECESSARILY RELATED TO THE
xEVMPD DEADLINE!
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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 !!!
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xEVMPD SERVICES
FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK
MedDRA coding of indications
Data collection & data entry
Database maintenance
xEVMPD compliance
Consultancy
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2000, Szentendre, Nap u. 52/21
www.xEVMPD.hu
1024, Budapest, Ady Endre u. 22.
THNANK YOU FOR YOUR INTERESTAND ATTENTION!