dr. katona botond accepther ltd. director, research and developmet our xevmpd solution dr. zajzon...
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Dr. Katona BotondAccepTher Ltd.Director, Research and developmet
our xEVMPD solution
Dr. Zajzon GergelyAccepTher Ltd.Director, Business development
Who weare?
our xEVMPD paradigm
xEVMPD compliance
DREAM
IT support for implementationand system-independentservice
- 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?
- 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?
EudraVigilance
UNITY OF REGULATORY REQUIREMENTS
OUR xEVMPD PARADIGM
07.02.
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
compliance &maintenance
procedure trackingworkflows
automated reporting
db
gwpm
wf
UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS
OUR xEVMPD PARADIGM
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
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
REPORTING, HANDLING OF REPORTS
gwpm
wf
db
according to theEudraVigilance scheme
XSD
xEVMPD COMPLIANCE
REPORTING, HANDLING OF REPORTS
xEVMPD COMPLIANCE
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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?
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
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
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
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!
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 !!!
xEVMPD SERVICES
FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK
MedDRA coding of indications
Data collection & data entry
Database maintenance
xEVMPD compliance
Consultancy
2000, Szentendre, Nap u. 52/21
www.xEVMPD.hu
1024, Budapest, Ady Endre u. 22.
THNANK YOU FOR YOUR INTERESTAND ATTENTION!