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

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

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

OUR xEVMPD PARADIGM
UNITY OF REGULATORY REQUIREMENTS
EudraVigilance
07.02.

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)

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

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

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
5,7 milli liter / 100
Example 2: 10 mg / tablet equals 10 milli gramm / 1 milli single liter liter tablet
/ -

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

xEVMPD COMPLIANCE
REPORTING, HANDLING OF REPORTS

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

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

DREAM: Drug Regulatory Electronic Affair Management
SYSTEM COMPONENTS: MODULARITY
XSD pm wf gw db
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

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

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

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

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

DREAM: Drug Regulatory Electronic Affair Management
INTERFACE
SSI
- 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

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

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

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

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

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

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 highlighted („registered”) events

DREAM: Drug Regulatory Electronic Affair Management
DATA MANAGEMENT
- product records handling parallels product lifecycle 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

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

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 SOP s

DREAM: Drug Regulatory Electronic Affair Management
BENEFITS OF A DREAM
XSD pm wf gw db
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

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

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

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

1024, Budapest, Ady Endre u. 22.
soldra@soldra.com
2000, Szentendre, Nap u. 52/21 contact@accepther.com