patient involvement in pharmacovigilance processes...• all perspectives are crucial and have...
TRANSCRIPT
An agency of the European Union
Overview of current patient involvement Patient involvement in pharmacovigilance processes
Twelfth Pharmacovigilance Stakeholder forum
Presented by Maria Mavris on 24 September 2018 Public Engagement Department, European Medicines Agency
Collaboration with patients: the EMA journey… so far
1995
1996
EMA created
Dialogue with HIV patients
Patients join COMP as full
members
Working group with patients created
Framework of interaction with patient
and consumer
organisations
Ongoing…
Patients and
Consumers Working
Party (PCWP) created
Dedicated Department created & framework updated
Systematic inclusion of
real life experience
EMA regulatory
output
Public Hearing/
Involvement of young people
2000 2005 2014
2003 2006 2017
Overview of current patient involvement 1
Patient involvement (2008 – 2017)
Overview of current patient involvement 2
Three categories of patient representation
Overview of current patient involvement 3
Patients representing their community
Overview of current patient involvement 4
Patients and EMA scientific committees
Working group with patients created
Patients and
Consumers Working
Party (PCWP) created
2005 2014
2003 2006 2017 Observers
Young people
Oral explanations
Overview of current patient involvement 5
Patients representing their organisation
Overview of current patient involvement 6
Patients and Consumers Working Party (PCWP)
Overview of current patient involvement 7
Patients as individual experts
Overview of current patient involvement 8
Patient involvement along the medicine lifecycle at EMA
CHMP PRAC
Post Marketing procedures
Expert mtg
POST AUTHORISATION PRE-SUBMISSION
COMP CAT
CHMP SAWP
PDCO
Orphan Designation
Scientific Advice
Paediatric Investigation
Plan
EVALUATION
CHMP CAT
PRAC COMP
Marketing Authorisation Evaluation
Expert mtg
Public Summaries of Opinion
Package Leaflets (PL) EPAR summaries
Package Leaflets (PL) (renewal)
Safety Communications
Patient input Overview of current patient involvement 9
Patients in scientific meetings
Overview of current patient involvement 10
Patients and review of documents
Overview of current patient involvement 11
Who do we work with?
• Any organisation representing EU patients or consumers may express an interest to work with the Agency, however they must meet the defined eligibility criteria (application form on the EMA website)
• List of eligible patients & consumers organisations published on the EMA website
• Individuals can also register to be involved
All images hyperlinked
Overview of current patient involvement 12
Patients in pharmacovigilance activities
Overview of current patient involvement 13
Members of PRAC
Albert van der Zeijden
Marco Greco
PRAC consultations of patients
Overview of current patient involvement 14
Examples Insulin : new strength box label design : extraction from pre-filled pens Dopamine dysregulation syndrome - questionnaire
Reporting side effects Review of safety communications
Overview of current patient involvement 15
Attendance to public hearing
2017: Valproate containing medicines 2018: Quinolones and fluoroquinolones
Overview of current patient involvement 16
• Engagement with patients:
Brings the everyday aspects of living with a disease into the scientific
discussions and helps bridge the gap between clinical trial data and real world data
Improves transparency and trust
Increases understanding and dissemination of EMA outcomes
Adds to quality of regulatory outcome
• ALL perspectives are crucial and have ultimately resulted in more meaningful
decisions for all concerned.
Importance of engaging with patients in EMA
Overview of current patient involvement 17
Any questions? Maria Mavris
Patient Liaison Public Engagement Department
www.ema.europa.eu
European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550 Send a question via our website www.ema.europa.eu/contact
Overview of current patient involvement 18