New principles give a voice to patients, consumers and carers under age 18 can make an important contribution to EMA’s committee discussions on medicines by sharing their experience and perspectives of living with a disease or condition.
These principles set out best practice for the interaction between parties on:
- Discussion in small groups
- Provision of specific support
- Use of appropriate language
- Obtaining parental consent
- Protection of personal data
- The privacy of the young patients.
The key forum in which young people could participate in the Agency’s activities would be its Paediatric Committee (PDCO), but experience has demonstrated that the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Scientific Advice Working Party (SAWP) can also benefit from this input when these groups review medicines for children.
For more information about this notice, please check the links below:
Involving young people in EMA activities
PRINCIPLES OF INVOLVING YOUNG PEOPLE ON THE EMA´s ACTIVITIES
