1. 1st meeting of the CIOMS Working Group XI, 19 April 2018
Patient involvement in the development and safe use of medicines: EMA perspective
1st meeting of the CIOMS Working Group XI, 19 April 2018
Presented by Isabelle Moulon, Senior Advisor on Stakeholders Engagement
Stakeholders & Communication Division

2. 29 April 2019
Who do we work with?
Through a network of eligible organisations fulfilling the following criteria:
Legitimacy
Mission/activities
Representation
Structure
Accountability
Transparency
Based on the EMA framework of interaction with patients, consumers and their organisations

3. Involvement along the medicine lifecycle at EMA
29 April 2019
Involvement along the medicine lifecycle at EMA
Public Summaries of Opinion
Product information
Product information
Safety Communications
CHMP
PRAC
Post Marketing procedures
Expert
mtg
POST AUTHORISATION
PRE-SUBMISSION
COMP
CAT
CHMP
SAWP
PDCO
Designation & Classification
Scientific Advice
Paediatric Plan
EVALUATION
CHMP
CAT
PRAC
COMP
Marketing Authorisation Evaluation
Expert
mtg
Patient input
HCP input
This is a visual representation of where stakeholders are involved all along the lifecycle of a medicine…
In this figure we show that patients and HCP are involved all along the medicines lifecycle from pre-submission to evaluation to authorisation as members of committees or in expert meetings or in the review of documents..

4. 360º view of patient engagement

5. Principles for engaging with patients
Keep your word and deliver
Develop trust
Seek mutual benefit
Build on mutual respect

6. Funding and remunerations Managing conflict of interests Training
Challenges
Funding and remunerations
Managing conflict of interests
Training
How to capture patient’s input from drug development to post-marketing phase?

7. Further information Follow us on @EMA_News 29 April 2019
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)
Send a question via our website
Follow us on @EMA_News
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