EU telematics in the regulation of pharmaceuticals

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Information about EU telematics in the regulation of pharmaceuticals

Published on May 30, 2007

Author: inemet

Source: slideshare.net

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PharmaCon2007 Conference Dubrovnik Croatia

EU Telematics Hans-Georg Wagner European Medicines Agency 05/26/09 Dubrovnik, Croatia, 22-27 May 2007

Objectives What is EU Telematics? Why do we need it? 05/26/09 Dubrovnik, Croatia, 22-27 May 2007

What is EU Telematics?

Why do we need it?

Overview Introduction Regulation of medicinal products in the EU/EEA The regulatory life of a medicinal product Matching IT systems 05/26/09 Dubrovnik, Croatia, 22-27 May 2007

Introduction

Regulation of medicinal products in the EU/EEA

The regulatory life of a medicinal product

Matching IT systems

Introduction IT polarises: necessary evil? Today’s regulatory workflows cannot work without IT! Look at regulation of pharmaceuticals in EU Then derive need for IT systems 05/26/09 Dubrovnik, Croatia, 22-27 May 2007

IT polarises: necessary evil?

Today’s regulatory workflows cannot work without IT!

Look at regulation of pharmaceuticals in EU

Then derive need for IT systems

Authorisation of Pharmaceuticals in the EU 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Biotech 4 Therapeutic Classes All others MUST CAN Centralised AP DCP MRP NAP

Biotech

4 Therapeutic Classes

All others

Centralised Authorisation Procedure - EMEA 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 The EMEA is responsible for the evaluation and supervision of medicines for human and veterinary use in the European Union.

The Regulatory Life of a Medicinal Product 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CT Application CT Registration R&D Clinical Trials Application Evaluation Authorisation Post Marketing Scientific Advice Safety Monitoring AE Reporting NAP DCP/MRP CAP Application Safety Monitoring AE Reporting Risk Management Safety Monitoring AE Reporting Risk Management GMP

Matching IT Systems at EU Level 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CT Registration R&D Clinical Trials Application Evaluation Authorisation Post Marketing Scientific Advice Safety Monitoring AE Reporting CAP Application Safety Monitoring AE Reporting Risk Management GMP EudraCT EudraGMP EudraVigilance EudraVigilance E-Subm.

EudraVigilance (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Adverse Event What happened? Which medicinal product? Which patient? Concomitant drugs? Active ingredients Route of Administration Pharmaceutical form

EudraVigilance (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Adverse Event represent Agreed Data Model ‘ E2B’ Valid Values Valid Values Valid Values Dictionaries of controlled terms/codes ICSR SUSAR

EudraVigilance (3) Why at EU-level? Signal detection is based on relative frequency of adverse events Earlier detection of potential signals Higher degree of confidence in signal 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Why at EU-level?

Signal detection is based on relative frequency of adverse events

Earlier detection of potential signals

Higher degree of confidence in signal

EudraVigilance (4) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Agreed Data Model ICSR HUMAN ICSR VET SUSAR HUMAN MedDRA EVMPD EV USERS EV CLIENT AXWAY EV WEB TRADER AXWAY CENTRAL GATEWAY DWH BI SE

EudraVigilance (5) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Agreed Data Model EVPM EVCTM EVMPD Prod. SUSAR ICSR Gateway ETL BI MSTR STATS SAS Reports Reports Data Cleaning Duplicate Detection EVIDS

EudraVigilance - Issues Need to include products from outside EU Need to implement controlled terms for Substances (active and excipients) Pharmaceutical form Route of administration Strength units Quality of source data Duplicate detection, recoding product data, validation Manage access policies for different stakeholders 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Need to include products from outside EU

Need to implement controlled terms for

Substances (active and excipients)

Pharmaceutical form

Route of administration

Strength units

Quality of source data

Duplicate detection, recoding product data, validation

Manage access policies for different stakeholders

EudraCT (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Protocol? Which Investigational MP? Sites? Sponsor? Active ingredients Route of Administration Pharmaceutical form Strength Clinical Trial Paediatric? Unique ID?

EudraCT (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Sponsor National Competent Authority Ethics Committee EudraCT Public Site Collect EudraCT Number Download Application Form Submit Application EudraCT Secure Site EudraCT Application EudraCT Repository Register Clinical Trial

EudraCT (3) Why at EU-level? Avoid duplication Share safety concerns Large percentage of multi-state trials 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Why at EU-level?

Avoid duplication

Share safety concerns

Large percentage of multi-state trials

EudraCT - Issues Need to link to EudraVigilance Need to know more about new product Need to include information on paediatric trials Data quality issues Usability issues (especially for NCAs) Manage access policies for different stakeholders 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Need to link to EudraVigilance

Need to know more about new product

Need to include information on paediatric trials

Data quality issues

Usability issues (especially for NCAs)

Manage access policies for different stakeholders

EudraPharm (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Regulatory data (MAH, dates, procedure…) Excipients Names, Codes Active ingredients Route of Administration Pharmaceutical form Strength Presentations Medicinal Product Paediatric? Unique Product ID? LBL PIL SPC

EudraPharm (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Structured Data Medicinal Product LBL PIL SPC Relational DB Text Repository Public Site Web Services

EudraPharm (3) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CAP (400) 23+1L DCP MRP (4000) N+1L NAP (400000) 1(+1)L EudraPharm All products All languages

EudraPharm (4) Why at EU-level? Safety monitoring Information sharing Decision support Mobility (Patients, Health Professionals,…) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Why at EU-level?

Safety monitoring

Information sharing

Decision support

Mobility (Patients, Health Professionals,…)

EudraPharm - Issues Need reference data model Need controlled terminology Need exchange standard NCAs should provide data (NAP+DCP/MRP) Data providers need to ensure quality and timeliness Role of industry? Links to other systems Manage access policies for different stakeholders 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Need reference data model

Need controlled terminology

Need exchange standard

NCAs should provide data (NAP+DCP/MRP)

Data providers need to ensure quality and timeliness

Role of industry?

Links to other systems

Manage access policies for different stakeholders

EudraGMP (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Medicinal Product GMP Inspectorates Member States Inspection Certificate Manufacturing Sites 1:n GMP Inspection Manufacturing Authorisation GMP Inspectorates MRA States Inspection Certificate GMP Inspection Negative Outcome Product Alert EudraGMP Database

EudraGMP (2) Why at EU-level? Avoid duplication, share effort Extend to MRA partners outside EU/EEA Mitigate risks (negative outcome) Rapid product alert 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’

Why at EU-level?

Avoid duplication, share effort

Extend to MRA partners outside EU/EEA

Mitigate risks (negative outcome)

Rapid product alert

05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Eudra GMP Eudra CT Eudra Vig. Eudra pharm e Subm. Reference Data Model EU Telematics Controlled Terminology EudraDataWarehouse EudraServices EudraNet, EudraLink, Web Services, SSO EudraPortal

05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Hans-Georg Wagner EMEA Communications and Networking [email_address]

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