SCOPE Work Package 6 Risk Communication on Medicines Workshop

Transcription

1 SCOPE Work Package 6 Risk Communication on Medicines Workshop Welcome on behalf of WP6 Team Dolores Montero, AEMPS Spanish Agency for Medicines and Medical Devices Madrid, 16 and 17 June 2016

2 Welcome on behalf of WP6 Team Ahlqvist-Rastad, Jane (MPA) Andric, Adriana (HALMED) Baldelli, Ilaria (AIFA) Barrow, Paul (MHRA) first part of the project Bouder, Frederic (Maastricht University, collaborator) Buckley, Niamh (HPRA) Cupelli, Amelia (AIFA Coleman, Anna Marie (HPRA) Escudero Fernández, Yvette (AEMPS) García, Juan (EMA, observer) Haddad, Rita (MHRA) first part of the project Hearn, Jess (MHRA) Knudsen,Yngvil (NOMA) Maartje van der Sar (Groningen Medical School) Maciá Martinez, Miguel Ángel (AEMPS) Mol, Peter (Groningen Medical School) Montero Corominas, Dolores (AEMPS) Michan, Line (DHMA) Samdal, Hilde (NOMA) Sieta de Vries (Groningen Medical SchoolSpooner, Almath (HPRA) Sipic, Ivana (HALMED) Root, Maria (MHRA) Rodriguez Pascual, Alfonso (AEMPS) Wennberg, Annika (MPA)

3 SCOPE Project Three-years project jointly funded by European Commission and participating Member States for strengthen implementation of pharmacovigilance legislation in all its aspects ( )

4 SCOPE co-ordination Strategic level European Commission Executive level Lead Member State - UK Project management, Budgetary control, Risk Register Reporting Communications General advisory board Representative from the stakeholder groups and the EC Chaired by coordinator/lead MS Work Package Leaders Group (Lead MS + WP Leads + Subproject leads) Implementation level WP4: ADR Collection HR WP5: Signal management NL WP6: Risk Communication ES WP7: Quality Management Systems HU WP8: Lifecycle pharmacovigilance IT WP 1 Coordination - UK WP 2 Dissemination - UK WP 3 Evaluation - PT

5 SCOPE Work Package 6 1- Audit of National Methods of Communications Findings about Risk Communications methods currently adopted by NCAs. Lead by MPA 2- Webportals Outline findings about MS websites, key aspects on the guideline and practical examples. Lead by MHRA

6 SCOPE Work Package 6 3- Impact Assessment of Risk Communication Findings about stakeholder attitudes, needs and preferences in relation to Risk Communication strategies currently in place. Lead by HPRA HCPs survey in 9 Member States (DK, NO, ES, HR, IE, IT, NL, UK, SE): GPs, cardiologists (pharmacists) 3,625 replies received and analysed Input from patients/citizens: collaboration from BEUC and EUPATI analysed

7 SCOPE Work Package 6 4- Good Practice Risk Communication Proposal for improvement. Lead by AIFA

8 What have we done? July 2014 NCA Surveys June 2015 HCPs Survey September 2015 Patients and Consumers Consultation March 2016 Webportals Good Practice Guidance May 2016 Proposal for improvement doc.

9 What do we expect from the Workshop? 1. Information about the survey results and current situation in Europe 2. Discussion of the main topics Break out sessions- practical workshop session. Small groups to critically review the proposals and provide input and new ideas Panel Discussion (6 panellists)

10 What do we expect from the Workshop? 3. Perspectives Frederic Bouder ( Overview on current knowledge ) Theo Raynor ( Communicating benefit and harm information ) My experience with Risk Communication by a Health Care Professional and a Patients representative 4. Future How to move forward- June Raine

11 Workshop Audience National Competent Authorities representatives 70 pax Health Care Professionals 15 pax Patients and Consumers 9 pax WHO representative Marie Lindquist Lareb representatives 2 pax EMA representative 2 pax EAMI representative Pilar Lagos Academia representatives 3 pax

12 WP6 Documents 1. Risk Communication Proposals for Improvement Annex 1: WP6 Survey Report Audit of National Methods of Communications Annex 2: WP6 Survey Report Patients and Consumers Consultation Annex 3: WP6 Healthcare Professional Survey Medicines Safety Communications and their Effectiveness 2. Good Practice Guide Web-based Safety Information Annex 1: SCOPE Web-portals survey report

13 Logistics Day 1 Coffee Break 11:00 h- 11:30h Lunch 13:30h 15:00h Meeting ends 17:30h Dinner 20.30h La Huerta Paradis C/ Marqués de Cubas 14 Day 2 Meeting starts 9.30h Coffee Break 11:15h 11:45h Meeting ends 13:15h

14 Many thanks, Your collaboration is essential!!