1. 1 Division of Pharmacoepidemiology and Pharmacovigilance AEMPS Dolores Montero Corominas 20 November 2015 1 Management of the Adverse drug reaction (ADR), the pharmacovigilance network and all other related national managed aspects

2. BIFAP Division Pharmacoepi and Pharmacovigilance, Head Administrative support PRAC and referral Unit Coordination Spanish PhV System Risk (BR) evaluation Pharmacoepi Unit Risk Management and communication

3. Comittees PRAC: European Pharmacovigilance Risk Assessment Committee Committee on Safety of Medicines: assessor committee. External experts (issues that may lead to relevant changes on the conditions of authorisation, educational materials with impact on national health system) Technical Committee of the Spanish Pharmacovigilance System (Spontaneous reporting, signal identification. 17 autonomous centers) Comitte of Posauthorisation observational studies (coordination with 17 regional authorities)

4. Coordination Spanish PhV System Pharmacoepi Unit Risk (BR) Evaluation Unit Risk Management and communication PRAC and Referrals Signals Risk Identification Methodological input on study protocols/results evaluation Impact of regulatory measures Comunications to Spanish PhV System

5. 5 Management of suspected ADRs 17 PhVRC + AEMPS (Spanish Agency of Medicinal products and Medical Devices) FEDRA = PhV Data base. Share the whole information in real time Users of FEDRA (Spanish Pharmacovigilance Data Base for ADRs) Access with digital certificates from any computer with internet access Share the whole information in real time Users of FEDRA (Spanish Pharmacovigilance Data Base for ADRs) Access with digital certificates from any computer with internet access

6. Coordination of the Spanish PhV System Guarantee homogeneous working standards Organise periodic technical committees Manage database Signals identified to PRAC, signals identified by other MS to Regional centers

7. 7  Receiver of all ADRs ocurring in their territory  ADR causality assesment (Yellow cards and ADR from MAH) and signal generation.  Data entry in the Spanish Phv database, FEDRA  Contact point for safety queries from HCP   Encourage HCP to report suspected ADR  Training courses  Signal detection MAH = Marketing Autorization Holder HCP = Health Care Professional ADR = Adverse Drug reaction ICSR = Individual Case Safety Report

8. Serious Serious and non serious Serious FEDRA 15 days 1 month Serious TAC

9. Serious and non serious EEE Serious out EEE FEDRA TAC Serious Non serious NEAR FUTURE 2017

10. 10 Web (notificaRAM.es), postal mail FEDRA HP FEDRA PhVRC 70% 30% Electronically: XML, web-tool Autonomous Community Autonomous Community MAH

11. ICSRs : –Queries and reports: Allows consultations in real-time to all ICSRs loaded in FEDRA. Medicines are coded, allowing controlled searches by both active substances and trade names. ADR can be found using and combining different categories of MedDRA, including SMQs. Additionally, there are approximately another 40 fields available to make queries, such as: date in which the ICSR is loaded, seriousness criteria, the outcome of the ADR, indication of the drug, etc. –MedDRA categories: To make standard queries with MedDRA. Equivalent to a local SMQ. –Requested ICSRs: It allows viewing different outputs of the consultations. Three current possibilities: “Excel format” with most of the data, a detailed form in “Word format”, or a line listing in “Word format”. –Maintenance: Allows loading, amendment or nullification of ICSRs. 11

12. 12 FEDRA PhVRC Yellow card

13. 13 236.955 ICSR * ICSR = Individual case safety report * Data updated the 1 st november 2015

14. https://www.notificaRAM.es

15. FEDRA EV Vigibase 15 Case evaluation + data-mining Data-mining

16. 16 Yellow Card Data quality and causality assessment Qualitative approach Quantitative approach FEDRA Aditional sources EV-PM Data mining Outputs Vigibase Data mining Outputs PSUR Studies, drug consumption,etc

17. 17 Phv RC Signal detection CTSEFV-H ((Technical Committee of the Spanish Pharmacovigilance System) National Signal Validation PRAC Recomendatio n to CHMP

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