By Marianne de Visser
The European Medicines Agency (EMA) has a Healthcare Professionals’ Working Party (HCPWP) in which EAN participates since 2013. Meetings are mostly held together with the Consumers’ and Patients’ Working Party.
The HCPWP provides recommendations to the EMA and its scientific committees on all matters of interest in relation to medicines.
Marianne de Visser is the EAN delegate to the HCPWP. Professor Yves Dauvilliers is alternate member.
Recently there has been a change in leadership. Professor Guido Rasi, who has been the Executive Director of the EMA for nine years, will be succeeded by Ms Emer Cooke, the first woman at the helm of EMA. She has worked at EMA before and more recently at WHO.
In his farewell message Professor Rasi reflects on the struggle of many countries across the globe with the COVID-19 pandemic. Over the next weeks and months, any developments in relation to the approval of COVID-19 treatments and vaccines in the EU will generate significant public interest and all eyes will be on EMA, dixit Rasi.
In order to provide further insight into the ongoing work on COVID-19 vaccines, EMA is organising an open virtual event on 11 December 2020, 1pm – 4.30pm with the following objectives:
• To inform the public and stakeholders about the EU regulatory process for approval of COVID-19 vaccines and on EMA’s role in their development, evaluation and approval;
• To listen to the public and stakeholder groups on their needs, expectations and any concerns, so that these can be considered in the relevant regulatory processes.
Registration is only needed for those who want to make a verbal intervention.
To give you a flavor of the topics that are discussed at EMA meetings (This is a link to the EMA Annual Report 2019)
- EMA Recommendations on vaccine preventable diseases including combatting vaccine hesitancy (development of the European Vaccination Information Portal by ECDC). EMA develops a vaccine outreach strategy.
- Move to using real world data to support decision making in Pharmacovigilance Risk Assessment
- New legislation for medical devices and in vitro diagnostics (NB: transitional period extended to May 2021 due to Covid-19 pandemic).
- The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). The goal of the Clinical Trial Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.
- Antibiotic resistance
- PRO (patient-reported outcome) data are increasing in importance from several healthcare perspectives. Potential for co-primary/composite endpoints in certain cases.
Interaction between EAN and EMA
The EMA information on COVID-19 was shared with the EANcore CoVID-19 Task Force.
EAN regularly receives requests for surveys and consultations. The EAN Scientific Committee and SPs are informed and/or involved whenever appropriate. If SP’s provide statements on drug developments these are published in EANPages.
A monthly Newsletter which includes decisions by EMA’s Scientific Committees and updates on medicines safety is circulated to the HCPWP. If of interest, the newsletter is circulated to the respective Scientific Panels.