3. Public hearings

The Announcement of the public hearing published on the EMA website, together with:

• A summary of the safety concern
• A list of specific questions
• Information on date, time and location of the public hearing
• Registration information
• Information on how to submit written contributions
• Contact email address and phone number
• Information about live-broadcast/web stream

Submitting a request to speak
Participation requests should be sent in writing to the EMA using a dedicated form and should include the following information:

• Capacity (e.g. patient, carer, doctor)
• Affiliation: Name of the organisation/group being represented (if applicable)
• Contact information
• Outline of the planned presentation/  specifically how it addresses the questions on which the PRAC is seeking public opinion
• Declaration of interest pertaining to the medicine(s) to be discussed at the public hearing

Review of requests to speak:

• All requests will be reviewed
• Efforts will be made to accommodate all speaking requests
• Speaking requests may be declined only if clearly unrelated to the subject matter of the public hearing
• Priority will be given to civil society representatives, such as patients, consumers, healthcare professionals and academic research groups or organisations, particularly those relevant to the therapeutic area
• Confirmation of attendance as a speaker at least 10 days in advance of the public hearing