1. 26 April 2019
Landscape of patient engagement, patients involved in regulatory initiatives Outline
CIOMS WG XI, October 2018
Presented by: Isabelle Moulon, EMA
Theresa Mullin, FDA
Denis Arsenault, Health Canada

2. depends on overlap with other sections
26 April 2019
Landscape of patient engagement - Patients involved in regulatory initiatives
Definition and context
Definition of patient engagement:
Identification of milestones, key decisions and when in the medicines life cycle
Includes patient engagement in policy / regulatory discussion or only diseases / product related
Context: emergence of patient engagement practices (HIV/AIDS crisis)
Methods:
Remain at high level
Contextualised or
depends on overlap with other sections

3. 26 April 2019
Landscape of patient engagement - Patients involved in regulatory initiatives
Common challenges:
Dealing with conflict of interest
Industry involving patients
How do regulators deal with it?
How do patients deal with it?
Managing expectations (patients/regulators)
Addressing competition/selection between organisations
Technical harmonisation- (patient experience data, definition of standards)
Resources to conduct and sustain patient engagement:
Capacity – capacity building – training
Compensation: financial/non financial
Sustainability
Recommendations on how to address the challenges – learning from experience to date

4. Questions Can we change the title of the section?
Landscape e.g. context and considerations
In which chapter do we give a definition of patient engagement?
Do we need definition according to the context, e.g. PE in regulatory initiatives?
Any overlaps with other chapters/sections?
Overall feed-back