EudraVigilance New Developm ents and Access to EudraVigilance Data - - PowerPoint PPT Presentation

An agency of the European Union

Presented by: Sabine Brosch (EMA, EU) and Sarah Morgan (MHRA, UK)

EudraVigilance New Developm ents and Access to EudraVigilance Data

Second Stakeholders Forum on the im plem entation of the new Pharm acovigilance legislation, 1 7 June 2 0 1 1

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• Update on enhanced EudraVigilance

functionalities in the context of the new legislation

• Access to adverse reaction data held in

EudraVigilance

Topics to be addressed

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• Implementation of the new ISO Individual Case

Safety Report (ICSR) standard

• Final standard expected end of 2011/ beginning 2012

Improved adverse reaction reporting and analysis

• Implementation of the new ISO Identification of

Medicinal Product (IDMP) standards

• Final standards expected end of 2011/ beginning

2012 Enhanced data quality, analysis and signal detection

Support use of international standards

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• Reporting by patients and consumers

Support new adverse reaction reporting rules

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Patients Consum ers Health Care Professionals National Com petent Authority

Reporting by patients, consumers and health care professionals to national Competent Authority

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• Simplified reporting rules for marketing

authorisation holders

Support new adverse reaction reporting rules

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Patients Consum ers Health Care Professionals

Reporting by marketing authorisation holders to EudraVigilance only

Marketing Authorisation Holder

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• Re-routing of ICSRs to the Member State where

the adverse reaction occurred

Support new adverse reaction reporting rules

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Patients Consum ers Health Care Professionals

Re-routing of adverse reactions to the national Competent Authority of the country where the adverse reaction occurred

Marketing Authorisation Holder National Com petent Authority

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• Reporting of ICSRs by the Agency to WHO
• Exchange of information on abuse of medicinal

products with the Agency and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)

Support new adverse reaction reporting rules

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Adverse reactions

• ccurring in the EU/ EEA

Adverse Reactions resulting from abuse

• f medicinal products

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• Functionalities to support the operation of procedures that

ensure quality and integrity of the information collected in EudraVigilance

• Validation or ICSRs against defined business rules
• Duplicate detection and management
• Coding of product information
• ICSR data quality review

Important for conduct of signal detection and benefit risk assessment Ensure that accurate and reliable data held in EudraVigilance are made available (EudraVigilance Access Policy)

High quality of adverse reaction data

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Filter

• Enhanced functionalities for NCAs, Agency and MAHs
• Access defined at the level of the EV Access Policy

Support Signal Detection and Evaluation

Adverse Reaction Level

Reaction HLGT Scientific Composition

• Numb. Adverse Reactions

Where age group = Adult

Medicinal Product Level Calculation

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• Full access to EEA Competent Authorities of the Member

States, to the Agency and the Commission

• Access to be implemented for patients, consumers and

health care professionals

• Data set for spontaneous reports
• Compliance with EU personal data protection legislation
• Access to be provided by easy to use data retrieval

functions and report outputs at the Agency’s website e.g. as aggregated summary reports or individual case report forms

Access to data held in EudraVigilance

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Access to data held in EudraVigilance

Pandem ic A/ H1 N1 influenza vaccines: Reports of ADRs ( EEA; up to 6 Jun 2 0 1 0 )

3,882 1,469 800 2,644 523 408 320 328 210 215 224 371 228 116 97 98 88 87 290 2,381 13,725 11,126 8,745 6,101 5,301 13,354 13,130 12,915 12,705 12,377 12,057 11,649 14,015 14,243 14,359 14,456 14,554 14,642 14,729

2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000

3- Dec- 09 9- Dec- 09 16- Dec- 09 23- Dec- 09 6- Jan- 10 13- Jan- 10 20- Jan- 10 27- Jan- 10 3- Feb- 10 10- Feb- 10 17- Feb- 10 24- Feb- 10 10- Mar- 10 24- Mar- 10 08- Apr- 10 21- Apr- 10 05- May- 10 20- May- 10 03- Jun- 10 18- Jun- 10

Date of update publication Num ber of case reports received New cases since last report Tot al received over t ime

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• Access for marketing authorisation holders planned as

follows:

• Data set for spontaneous reports
• Compliance with EU personal data protection legislation
• Access to EudraVigilance Data Warehouse and Analysis

System (EVDAS) and data analysis and signal detection tools

• Results of EVDAS queries to be downloadable and printable

either in aggregated format (e.g. as tabular or graphic presentations, line listings) or as individual report forms

• Downloads in ICH E2B format and in accordance with the

ICH M2 message specifications

Access to data held in EudraVigilance

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• Access to research organisations planned as follows:
• Ad-hoc committee to review requests for research
• Agency may refuse access if there is no public health

value or if there is conflict with legal responsibilities of the Agency

• Data set for spontaneous reports
• Compliance with EU personal data protection legislation
• Access to EVDAS and its data analysis and signal

detection tools

• Results of EVDAS queries to be downloadable and

printable either in aggregated format (e.g. as tabular or graphic presentations, line listings) or as individual report forms

Access to data held in EudraVigilance

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Discussion

Contacts: sabine.brosch@ema.europa.eu Sarah.Morgan@mhra.gsi.gov.uk