Patient involvement in pharmacovigilance processes...• ALL perspectives are crucial and have...

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

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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

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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

maria.mavris@ema.europa.eu

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

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