Dr. Katona Botond AccepTher Ltd. Director, Research and developmet our xEVMPD solution Dr. Zajzon Gergely AccepTher Ltd. Director, Business development

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

http://accepther.com/wp-content/gallery/02/xevprm2.png

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


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


- 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









INTERFACE









INTERFACE









INTERFACE

SSI









INTERFACE





- customizable end-user interface in function of responsibilities: - regulatory - medical




INTERFACE





- customizable end-user interface in function of responsibilities: - regulatory - medical




INTERFACE

XML-GENERATION AND VALIDATION


- according to XSD

- According to xEVMPD Business Rules

- validation log, report

XML handling ~ workflow

- ACK handling

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

EVENT 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


- 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


- 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


- 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


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


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

[email protected]

www.xEVMPD.hu

1024, Budapest, Ady Endre u. 22.

[email protected]

THNANK YOU FOR YOUR INTERESTAND ATTENTION!

mailto:[email protected]



http://www.xevmpd.hu/




Documents

Dr. Katona Botond AccepTher Ltd. Director, Research and developmet our xEVMPD solution Dr. Zajzon Gergely AccepTher Ltd. Director, Business development