1. Public hearings

1.7. Organisation of a public hearing: Before the hearing

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