1. Public hearings

1.5. Who can attend?


Public hearings are open to all members of the public, including patients and healthcare professionals. The questions asked by the PRAC to be addressed during the hearing determine the target audience.

The marketing authorisation holder(s) has/have the opportunity to present its/their view(s).

Media organisations who wish to cover the public hearing may attend as observers.

PRAC members and EMA staff will also attend.


Modalities:

Participants will be asked to register in advance.

Members of the public can participate actively, as speakers, or they can opt to participate as observers.

Speakers can make an intervention in person or via teleconferencing. Supporting documentation presented by the speakers during the intervention will be published on the EMA website following the public hearing.

Where space permits, requests to observe the public hearing in person without making an intervention will be accommodated.

The proceedings of the public hearing can also be observed via video broadcast on the EMA website.