During the summer, Angela Bradshaw (Director for Research) joined a virtual meeting of the EMA Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP). The first day was kicked off by Juan Burgos (EMA) and Marko Korenjak (European Liver Patients’ Association), co-Chairs of the PCWP, who welcomed online and in-person attendees to the meeting. Kaisa Immonen and Maria Mavris (EMA) started the meeting by providing an update on patient involvement in scientific advice procedures, and during the evaluation phase of medicines, with the CHMP. Kaisa outlined the methodologies that have been put in place to ensure that the patient voice is captured during the ‘evaluation’ phase of the medicine regulatory pathway. After a brief discussion on how experts are remunerated for their involvement in EMA activities, the agenda moved on to a presentation of how the EMA interacts with other regulatory agencies, focusing on the US FDA and the African Medicines Agency. Forums set up by the EMA to enable these interactions include the EMA-FDA patient engagement cluster and PCWP and FDA-CTTI Patient Engagement Collaborative (PEC), Maria Mavris explained. The final section of the PCWP meeting focused on the 2022-2025 workplan for the Working Party, which has been refined following a survey addressed to the PCWP members.
The next day, a joint meeting of the PCWP and the Healthcare Professionals’ Working Party was convened, by co-Chairs Juan Burgos, Marko Korenjak and Rosa Giuliani (European Society for Molecular Oncology). This joint meeting focuses on topics of particular relevance to both stakeholder groups, with a series of detailed, informative presentations from EMA colleagues. The first topic, which was presented by Melanie Carr (EMA), addressed the European Medicines Agency Network Strategy. This strategy, which has been extended to 2028 (from 2025), identifies shared goals, priorities and challenges for the Heads of Medicines Agencies (HMA; a network of national regulatory agencies) and EMA, guiding their collaborative work. Next came the member’s voice section, where Francois Houyez of EURORDIS shared their analysis of medicines overviews from 179 CHMP opinions on medicines for rare diseases (issued between 2019-2023). Next, Mary McCarthy of the European Union of General Practitioners (UEMO) highlighted challenges for prescribing, and explained how more multidisciplinary collaboration could facilitate more effective prescribing of medicines by GPs.
After a short coffee break, the meeting reconvened with an EMA-led session on clinical trial activities, with presentations on the Clinical trials raw data pilot (by Frank Pétavy) and updates on the ACT EU and multistakeholder platform (Ana Zanoletty). Angela is a member of the Network Advisory Group on Raw Data, and provided brief reflections on stakeholder involvement through her work as part of this group. Dina Duarte (EMA) then spoke about an ongoing revision of the EMA guideline on Risk Assessment of Medicines on Reproduction and Lactation, presenting a concept paper that has recently been published. The final third of the meeting was dedicated to transparency activities and biosimilars. Francesca Scotti (EMA) presented the revised transparency rules for the Clinical Trials Information System (CTIS), which became available on 18 June 2024 with the launch of a new version of the CTIS public portal. Closing the meeting, Juan, Marko and Rosa thanked all attendees for their contributions and presentations, reminding attendees that the next meeting will be held in November. Access the agenda, meeting summary and presentations:
