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

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 Presented by: Sabine Brosch (EMA, EU) and Sarah Morgan (MHRA, UK) An agency of the European Union

Topics to be addressed • Update on enhanced EudraVigilance functionalities in the context of the new legislation • Access to adverse reaction data held in EudraVigilance 2

Support use of international standards  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 3

Support new adverse reaction reporting rules  Reporting by patients and consumers 4

Health Care Professionals National Com petent Authority Reporting by patients, consumers and health care professionals to Patients national Competent Authority Consum ers 5

Support new adverse reaction reporting rules  Simplified reporting rules for marketing authorisation holders 6

Health Care Professionals Marketing Authorisation Holder Reporting by marketing authorisation holders to EudraVigilance only Patients Consum ers 7

Support new adverse reaction reporting rules  Re-routing of ICSRs to the Member State where the adverse reaction occurred 8

National Com petent Health Care Authority Professionals Marketing Authorisation Holder Re-routing of adverse reactions to the national Competent Authority of the country where Patients the adverse reaction occurred Consum ers 9

Support new adverse reaction reporting rules  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) 10

Adverse reactions occurring in the EU/ EEA Adverse Reactions resulting from abuse of medicinal products 11

High quality of adverse reaction data  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) 12

Support Signal Detection and Evaluation  Enhanced functionalities for NCAs, Agency and MAHs  Access defined at the level of the EV Access Policy Medicinal Product Level Calculation Scientific Composition Reaction HLGT Numb. Adverse Reactions Adverse Reaction Level Where age group = Adult Filter 13

Access to data held in EudraVigilance  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 14

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 ) Num ber of case reports received 16,000 14,554 14,729 14,359 14,015 14,642 14,000 13,130 14,456 12,705 14,243 12,377 13,725 13,354 11,649 12,915 12,000 11,126 12,057 10,000 8,745 8,000 6,000 5,301 6,101 3,882 4,000 2,644 2,381 1,469 2,000 800 523 408 320 328 210 215 224 371 290 228 116 97 98 88 87 0 08- 21- 05- 20- 03- 18- 3- 9- 16- 23- 6- 13- 20- 27- 3- 10- 17- 24- 10- 24- Dec- Dec- Dec- Dec- Jan- Jan- Jan- Jan- Feb- Feb- Feb- Feb- Mar- Mar- Apr- Apr- May- May- Jun- Jun- 09 09 09 09 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 Date of update publication New cases since last report Tot al received over t ime 15

Access to data held in EudraVigilance  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 16

Access to data held in EudraVigilance  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 17

Discussion Contacts: sabine.brosch@ema.europa.eu Sarah.Morgan@mhra.gsi.gov.uk 18