Beruflich Dokumente
Kultur Dokumente
Centralised Procedure
1 application 1 evaluation 1 authorisation for all EU
The importance of patient input for the work of the European Medicines Agency
Framework of interaction: principle of patient empowerment Patient involvement /patient information/ patient safety Role of patients/consumers organisations as multipliers of the interaction (promoting patient safety)
Structure
Accountability and consultation modalities Transparency
Improve the availability of information on the use of medicines for older people
Informed prescription
Which studies have been carried out? Are they in line with current guidelines?
Can relevant information be found in the EMA approval documents? What would prescribers, patients and HTA bodies like to know?
10
1. ..ensuring that the development and evaluation of new medicines takes into account specific safety and efficacy aspects related to aging, in accordance with current guidelines, particularly ICH E7
2. ..identifying gaps in regulatory and scientific knowledge and taking appropriate measures to tackle them
Other Aspects
Endpoints - Depending on frailty/disability the desirable outcome and treatment decisions might differ with age
Clinical trial recruitment - Make use of existing patients networks + CT outcome measures should be relevant to old people Product information-Channels of information are important- specific measures are needed particularly as the older group is non-homogeneous Better focus on Package leaflet: explain how to take medicine/increase compliance/PK and PD changes/concomitant medication Pharmacovigilance: Patient reporting, signal detection; post-authorisation studies.
Appropriate formulations?
Formulation Development
Drug
Drug application
Process Development
Weighing
Manufacturing
Thank you!
Questions?
francesca.cerreta@ema.europa.eu