On 2-3 March, the European Medicines Agency (EMA) hosted an online meeting of its Patient and Consumer’s (PCWP) and Healthcare Professionals Working Parties (HCPWP). The meeting was attended by all eligible patient organisations and professional bodies, and was chaired by Juan Garcia Burgos (EMA), Kaisa Immonen (European Patient’s Forum; PCWP) and Ulrich Jaeger (HCPWP). Angela Bradshaw (Project Officer) represented AE at the meeting. The first half of the meeting was kicked off by Marco Cavaleri and Priya Bihari of EMA, who provided updates on COVID-19 vaccines, therapeutics and their safety surveillance. Marco outlined the results of new research on the efficacy of vaccination and boosters against the omicron variant of COVID-19, and explained how recently-approved treatments like Paxlovid work to reduce the severity of disease.
Priya focused on the safety surveillance that EMA carries out for COVID-19 vaccinations and treatments, highlighting a new section of the EMA website dedicated to accessible information on safety that can help combat misinformation. Next, representatives outlined recent activities and progress on different EMA initiatives and projects, including the ACT-EU (Accelerating Clinical Trials in the EU), DARWIN (Data Analysis and Real-World Interrogation Network) and BDSG (Big Data Steering Group). ACT-EU was launched in January this year and aims to transform the EU clinical research environment, building on the new Clinical Trials Regulation in support of medical innovation and better patient outcomes. DARWIN is a federated network of data, expertise and services that is working on supporting the use of real-world evidence in clinical trials and for regulatory decision-making. Meanwhile, the BDSG progress report highlighted ongoing work on promoting stakeholder involvement in EMA initiatives on real-world data, and plans to enable data transformation of the EU regulatory network – a key deliverable for the EMA Network Strategy.
Inga Abed (EMA) drew day 1 of the meeting drew to a close by explaining how EMA plans to engage stakeholders and communicate about its extended mandate, which reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. The second day of the EMA PCWP/HCPWP meeting was mainly focused on awareness-raising and the perspectives of member organisations of the PCWP and HCPWP. First on the agenda was Ana Hidalgo of EMA, who delivered a presentation explaining how advanced therapy medicinal products (ATMPs) such as gene and cell therapies are developed and evaluated at the European level.
Next, representatives of member organisations spoke about topics of particular relevance to medicines development; among others, Natacha Bolanos of the European Haematology Association explained their recommendations for reducing bureaucracy in clinical trials, while Marilena Vrana of the European Heart Network spoke about issues with the implementation of the EU Medical Device Regulation and the availability of cardiac devices for patients with heart diseases. The meeting was drawn to a close by the two co-Chairs, Kaisa Immonen and Ulrich Jaeger, who were thanked for their hard work over the past two years. New co-Chairs will be elected later this year, and will lead the PCWP and HCPWP during the upcoming EMA mandate between 2022-2025.
