Transcript DREAM: Drug Regulatory Electronic Affair Management

our xEVMPD solution
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
up-to-date knowledge of requirements
and
INDUSTRIAL
AUTHORITY
- product development
- clinical development
- REGULATORY AFFAIRS
- strategic consulting
- (…)
- local representation
- PHARAMCOVIGILANCE
- PV system
- (…)
- local PV tasks
- PRICING AND REIMBURSEMENT
CONSULTANCY (HUNGARY)
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
validated and independent
Regulatory data and process management
SOFTWARE
- REGULATORY ASSISTANCE
- PIL redability testing
- translations
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
pm
gw
procedure tracking
workflows
automated reporting
wf
compliance &
maintenance
db
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
XSD
db
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
liter
5,7
milli
liter
/
100
milli
liter
gramm
/
1
single
/
-
-
Example 2: 10 mg / tablet
equals
10
-
milli
-
-
tablet
-
xEVMPD COMPLIANCE
REPORTING, HANDLING OF REPORTS
pm
gw
wf
XSD
db
according to the
EudraVigilance scheme
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
„THICK CLIENT”
- Windows operating system
- MS .Net Framework 3.5 SP1 & 4.0
FILE POOL
DATABASE
- database server (dedicated PC)
INTRANET
DREAM: Drug Regulatory Electronic Affair Management
SYSTEM COMPONENTS: MODULARITY
D – Drug product database
pm
gw
wf
R – Registry book
E – Electronic process management
A – Audit trail
M – Management and reporting
X – xEVMPD compliance
XSD
db
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
- standard administration and
end-user interface
- controlled vocabularies a priori
enclosed
- xEVMPD data structure
compliant Product Data Sheet
SSI
- 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 SOPs
DREAM: Drug Regulatory Electronic Affair Management
BENEFITS OF A DREAM
D – Data safety
pm
gw
wf
R – Robustness of the IT platform
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
DREAM: Drug Regulatory Electronic Affair Management
TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION
2001
EudraVigilance
2005
2008.12
First RIMs live (MS-Access )
EU RDM v 2.0
2009.07
DREAM release 1.0 live
DREAM: CT module live (CTA)
2010.12
Directive 2010/84/EU
Regulation 1235/2010
2011.07
Art 57(2) Legal notice
2011.09
xEVMPD guidance 2.0
DREAM: 7x
2012.03
xEVMPD guidance 3.0
DREAM Lite – xEVMPD (1)
DREAM release 2.0
2012.04
FileFlower gateway
2012.07
xEVMPD deadline
?
xEVMPD guidance 4.0 (SSI)
+ 3 hó
DREAM: PV module live
(PSUR, CIOMS)
NOT NECESSARILY RELATED TO THE
xEVMPD DEADLINE!
User specification
Data ”migration”, config.s
Operational implementation
DREAM / DREAM Lite – xEVMPD (2)
2 mo
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.
[email protected]
2000, Szentendre, Nap u. 52/21
[email protected]
THNANK YOU FOR YOUR INTEREST
AND ATTENTION!
www.xEVMPD.hu