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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.

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slide1

our xEVMPD solution

Dr. Zajzon Gergely

AccepTher Ltd.

Director, Business development

Dr. Katona Botond

AccepTher Ltd.

Director, Research and developmet

slide2

Who weare?

our xEVMPD paradigm

xEVMPD compliance

DREAM

IT support for implementation

and system-independent

service

slide3

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

slide4

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

slide5

OUR xEVMPD PARADIGM

UNITY OF REGULATORY REQUIREMENTS

EudraVigilance

07.02.

example hungary
EXAMPLE: HUNGARY

OUR xEVMPD PARADIGM

UNITY OF REGULATORY REQUIREMENTS – DIVERSITY OF MARKET PLAYERS

Distribution of MAs

between local market players

(excl. representative offices)

Distribution of MAHs per number of Mas

between local market players

(excl. representative offices)

slide7

OUR xEVMPD PARADIGM

UNITY OF REGULATORY REQUIREMENTS – DIFFERENT TASKS

pm

gw

procedure tracking

workflows

automated reporting

wf

compliance &

maintenance

db

slide8

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

examples handling of concentration data
EXAMPLES: HANDLING OF CONCENTRATION DATA

xEVMPD COMPLIANCE

DATA COLLECTION AND DATA ENTRY

Example 1: 5,5-5,7 ml/ 100 ml

milli

liter

range

5,5

/

milli

liter

100

milli

liter

5,7

/

milli

liter

100

Example 2: 10 mg / tablet

milli

gramm

equals

10

/

single

tablet

1

-

-

-

/

-

-

-

slide10

xEVMPD COMPLIANCE

REPORTING, HANDLING OF REPORTS

according tothe

EudraVigilance scheme

pm

gw

wf

XSD

db

slide11

xEVMPD COMPLIANCE

REPORTING, HANDLING OF REPORTS

slide12

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
slide13

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)

slide14

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

slide15

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide16

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide17

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide18

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide19

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide20

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide21

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide22

DREAM: Drug Regulatory Electronic Affair Management

INTERFACE

- standard administration and

end-user interface

- controlled vocabularies a priori

enclosed

  • xEVMPD data structure
  • compliantProduct 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
slide23

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

slide24

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
slide25

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

slide26

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
slide27

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
slide28

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

slide29

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

slide30

DREAM: Drug Regulatory Electronic Affair Management

TIMELINES: REGULATORY – DEVELOPMENT – IMPLEMENTATION

2001

EudraVigilance

2005

First RIMs live (MS-Access )

2008.12

EU RDM v 2.0

DREAM release 1.0 live

2009.07

DREAM: CT module live(CTA)

2010.12

Directive 2010/84/EU

Regulation 1235/2010

DREAM: PV module live

(PSUR, CIOMS)

2011.07

Art 57(2) Legal notice

DREAM: 7x

2011.09

xEVMPD guidance 2.0

DREAM Lite – xEVMPD (1)

2012.03

xEVMPD guidance 3.0

NOT NECESSARILY RELATED TO THE

xEVMPD DEADLINE!

DREAM release2.0

2012.04

FileFlowergateway

Userspecification

2 mo

2012.07

xEVMPD deadline

Data ”migration”, config.s

Operational implementation

xEVMPD guidance 4.0 (SSI)

?

+ 3 hó

DREAM / DREAM Lite – xEVMPD (2)

slide31

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
slide32

FEJLESZTŐI TÁMOGATÁS & REDSZER-FÜGGETLEN SZOLGÁLTATÁSOK

xEVMPD SERVICES

Data collection & data entry

MedDRA coding of indications

Databasemaintenance

xEVMPD compliance

Consultancy

slide33

1024, Budapest, Ady Endre u. 22.

2000, Szentendre, Nap u. 52/21

soldra@soldra.com

contact@accepther.com

THNANK YOU FOR YOUR INTEREST

AND ATTENTION!

www.xEVMPD.hu