The Commission is re-opening the selection procedure to appoint the Representatives of Patients’ Associations and Clinicians in the Committee for Advanced Therapies of the European Medicines Agency, originally launched on 12 August 2024.The reopening is...
CBER will host a public patient listening meeting to better understand patient and carer perspectives on enrollment of rare disease patients into gene therapy clinical trials in the pre-symptomatic or early symptomatic stages of their...
The FDA has issued a draft guidance to propose revisions to the 2016 guidance to reflect the current scope of FDA’s benefit-risk paradigm, which may under appropriate circumstances, include patient preference information (PPI), and to provide additional...
The overhaul of the EU pharmaceutical legislation, which includes the definition of unmet medical need, was adopted by the EC in April 2023. This definition carries significant implications as it shapes pharmaceutical companies’ eligibility for regulatory...
The consultation sought responses from a wide range of stakeholders on proposals to amend the Human Medicines Regulations 2012 (HMRs) to enable pharmacy technicians to supply and administer medicines using patient group directions (PGDs). The...
Representatives of Patients’ Associations and Clinicians: Call for expressions of interest is open for the EMA Committee for Advanced Therapies. The Commission is launching a selection procedure to appoint the Representatives of Patients’ Associations and...
This virtual training for representatives of patients, consumers and healthcare professionals’ organisations aims at presenting an overview of medicines regulatory activities. Using a combination of presentations, plenary discussions and breakout sessions, participants will learn more...
This meeting brings together all eligible patient and consumer and healthcare professionals organisations and members of the Patients’ and Consumers’ Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP). The meeting focuses on the following topics: EMA data related...
The EMA published the report, the presentation materials and the video recording of the Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries held the 12 and 13 February 2024....
Nous créons un comité scientifique temporaire (CST) « conditions de mise en œuvre de la substitution des médicaments biologiques similaires » chargé de définir dans quelles conditions les pharmaciens pourront substituer des médicaments biosimilaires. Il...
