October 4, 2022
European Medicines Agency news
The European Medicines Agency has kept itself very busy and we would like to highlight the following items:
Publication of the EMA good practice guidance for patient and healthcare professional organisation on the prevention of shortages of medicines for human use, to which IPOPI submitted some suggestions that have been included in the final paper. This paper aims to be used as an inspiration for organisations of patients and healthcare professionals and IPOPI drew from its expertise as well as from the NMOs’ experiences to input the document.
IPOPI participation in the EMA Multi-stakeholder workshop on patient experience data in medicine development and regulatory decision-making, September 21
Jose Drabwell (IPOPI Board member) attended the first EMA face-to-face meeting in three years, which was recently held at the EMA offices. Patients, healthcare professionals, academia, regulators, and industry all took part in the workshop, which focused on the collection and use of patient experience data to achieve patient-centred medicine development and regulation. The EMA has been interacting with patients since 1995 and in 2014 it was made official. Now patients are involved in Scientific Advice, early contact with the Committee for Medicinal Products for Human Use, Review of documents, Safety Monitoring, Risk Minimisation, Public Hearings and much more.
EMA Patients and Consumers Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP), 22 September
The following day, Jose Drabwell also participated in the PCPW and HCPWP meetings. The agenda featured several important topics such as:
- The election of two new working party co-chairs, namely Marilena Vrana (EHN) European Heart Network by the PCWP and Rosa Giuliani (ESMO) European Society for Medical Oncology by the HCPWP.
- An update by Marco Cavaleri, Head of the office of biological health threats and vaccine strategy at the EMA, who presented on several different vaccines. He mainly focused on the new bivalent boosters and therapeutics available to treat COVID-19, as well as Monkeypox.
EMA – Emergency Task Force (ETF)
A recent ETF meeting was also held. The ETF is an advisory and support body that handles regulatory activities in a public health emergency, such as a pandemic. IPOPI has been a delegate of this ETF since the beginning of 2022 and attends weekly meetings.
