10 September 2025 - The Danish Medicines Agency, Copenhagen

VSFG (Veterinary Strategic Focus Group) is a group established jointly by the HMA and EMA focusing on strategic topics within veterinary medicines in Europe. Therefore, the meeting discussions concentrated on overall collaboration, the needed resources within the veterinary regulatory network in the EU and the upcoming tasks related to the ongoing work of harmonising the summaries of product characteristics for selected types of veterinary medicines in the EU.

Above: Veterinary Strategic Focus Group gathered in Copenhagen 10 September 2025

10 September 2025

Scandic Copenhagen, Copenhagen

10 - 12 September 2025 - Scandic Copenhagen, Copenhagen

Megatrends in healthcare was one of the hot topics when the Danish Medicines Agency hosted its first meeting during Denmark’s EU Presidency.

The meeting gathered the Heads of Medicines Agencies (HMA) in Europe, who together with invited keynote speakers explored the trends likely to shape the future responsibility areas of the medicines agencies. The meeting also discussed other topics, such as pharmaceuticals in the environment, clinical trials and medical devices.

The meeting discussions will form part of the input that the European medicines agencies will consider in developing the upcoming strategy of the European medicines regulatory network (EMRN), set to take effect in 2028.

Above: Heads of Medicines Agencies gathered in Copenhagen 10 - 12 September 2025

16 - 18 September 2025 - Scandic Falkoner, Frederiksberg

With more than 500,000 different types of medical devices – used for diagnosis, prevention, alleviation, or treatment of disease, disability and more – medical devices are obviously of critical importance to patients across the EU. The same can be said for the underlying community legislation.

This meeting brought together medical devices experts from across Europe and included discussions of the upcoming revision of European medical devices legislation.

Above: CAMD and CEG gathered in Copenhagen 16 - 18 September 2025

24 - 26 September 2025 - Scandic Copenhagen, Copenhagen

Veterinary medicines is an important regulatory area of the medicines agencies in Europe. Together the agencies pursue a clear goal of ensuring safe, accessible and effective veterinary medicines.

This goal is at the centre of the joint meeting of two EU veterinary expert groups whose focus includes:

• reduction of the number of test animals, improvement of animal welfare and replacement of animal use with alternatives
• antibiotic use and the work with antimicrobial resistance
• accessibility of veterinary medicines and electronic package leaflets
• pharmaceuticals in the environment and the correlation between laws in the environmental area.

Above: CVMP and CMDv gathered in Copenhagen 24 - 26 September 2025

24 - 26 September 2025 - Scandic Copenhagen, Copenhagen

Veterinary medicines is an important regulatory area of the medicines agencies in Europe. Together the agencies pursue a clear goal of ensuring safe, accessible and effective veterinary medicines.

This goal is at the centre of the joint meeting of two EU veterinary expert groups whose focus includes:

• reduction of the number of test animals, improvement of animal welfare and replacement of animal use with alternatives
• antibiotic use and the work with antimicrobial resistance
• accessibility of veterinary medicines and electronic package leaflets
• pharmaceuticals in the environment and the correlation between laws in the environmental area.

Above: CVMP and CMDv gathered in Copenhagen 24 - 26 September 2025

28 - 30 September 2025 - Scandic Copenhagen, Copenhagen

Strengthening the clinical trials framework was the main topic for the meeting of the Clinical Trials Coordination Group (CTCG).

Denmark is doing quite well in terms of the number of clinical trials conducted per million inhabitants. But for the EU as a whole, it is essential to create an even more attractive environment for pharmaceutical development and research, ensuring that patients have quick access to the newest medicines available.

At the meeting, the Danish Medicines Agency also presented its preliminary findings on the recently introduced accelerated assessment of early-phase trials, where sponsors of phase I clinical trials and phase I/II trials in Denmark receive responses to their applications within 14 days.

Above: Clinical Trials Coordination Group gathered in Copenhagen 28 - 30 September 2025

30 September - 1. October 2025

The Danish Medicines Agency, Copenhagen

1 - 3 October 2025 - Scandic Falkoner, Frederiksberg

This European expert group examines questions relating to marketing authorisations for medicines in two or more EU Member States or variations to marketing authorisations – the overall purpose being to harmonise processes across the EU and ensure the availability of high-quality medicines in the EU.

The agenda for this meeting included antibiotic use and minimisation of antimicrobial resistance, responsible use of artificial intelligence and better use of the resources of the European network of medicines agencies.

Above: CMDh gathered in Copenhagen 1 - 3 October 2025.

6 - 8 October 2025 - Scandic Copenhagen, Copenhagen

At this meeting, the European network of quality experts – the Working Group Quality Managers (WGQM) – gathered to highlight the importance of the quality work carried out within medicines agencies across all EU countries to maintain trust that medicines are safe, effective, and manufactured under controlled conditions.

As part of the meeting, the Danish Medicines Agency’s team hosted a workshop focusing on how EU member states introduce new colleagues to quality as a professional field. This is an important effort to ensure a streamlined approach to quality across units, teams, and competencies within the European authorities.

Above: WGQM gathered in Copenhagen 6 - 8 October 2025.

8 - 10 October 2025 - Scandic Falkoner, Frederiksberg

The main task of this committee is to ensure the safe and evidence-based use of herbal medicinal products across the EU – including through EU monographs on herbal medicines, which help ensure that they are used safely and in line with European recommendations.

On our LinkedIn page, you can read more about the varied agenda, featuring contributions from both Danish Medicines Agency staff and external speakers invited to provide additional perspectives on the professional content.

Above: HMPC gathered in Copenhagen 8 - 10 October 2025

20 - 22 October 2025

Crowne Plaza, Copenhagen

22 - 24 October 2025

Radisson Blu Scandinavia, Copenhagen

22 - 24 October 2025 - Radisson Blu Scandinavia, Copenhagen

At the meeting, participants discussed, among other things, whether and how real-world data can be used to support regulatory decision-making, the approach to surrogate endpoints, and the latest regulations concerning companion diagnostics.

In addition, there was also an opportunity to exchange experiences with the participants of the CHMP meeting, which took place in parallel with the SAWG meeting.

Above: SAWG gathered in Copenhagen 22 - 24 October 2025.

27 - 29 October 2025 - Bella Sky, Copenhagen

The COMP meeting focused on regulatory and scientific issues of significance for rare diseases. The agenda included, among other things, presentations on the use of real-world data as well as European cooperation in the field of rare diseases. In addition, the committee discussed future initiatives – including the upcoming European pharmaceutical legislation.

In a separate joint CAT/COMP session, antimicrobial resistance and Danish initiatives to promote access to advanced therapies and medicines for rare diseases were in focus.

With speakers from the University of Copenhagen, Rigshospitalet, industry, the Danish Medicines Agency, and the committee members themselves, the discussions covered a wide range of topics in both form and content.

28 - 30 October 2025 - Bella Sky, Copenhagen

The meeting of the Committee for Advanced Therapies focused on regulatory and scientific developments of strategic or educational relevance for the committee members, such as criteria for assessing whether clinical data are sufficient in scope to support marketing authorisation (the Lisbon criteria), the status of the clinical pipeline for regenerative stem-cell therapies (Parkinson’s, diabetes, heart disease), and the use of AI in the development of advanced therapies.

In addition, a joint session was held with the participants of the COMP meeting, which took place in parallel with the CAT meeting (see also the report on the COMP meeting).

Above: CAT gathered in Copenhagen 28 - 30 October 2025.

4 November 2025 - Crowne Plaza, Copenhagen

At this meeting, leaders from the European Health Technology Assessment (HTA) organisations gathered to mark an important milestone in the joint European effort to implement the HTA Regulation.

The aim of the Regulation is to strengthen assessments as a basis for decisions on new medicines and medical devices – thereby ensuring that patients across Europe have access to effective and safe treatments, and that healthcare resources are used in the best possible way.

Above: HAG gathered in Copenhagen 4 November 2025.

6 - 7 November 2025 - Crowne Plaza, Copenhagen

Based on the ‘Triple A’ agenda — Availability, Accessibility, and Affordability — this meeting focused on how to promote competition, transparency, and a more demand-driven approach to the development of and access to medicines in the EU.

The meeting took place under the auspices of the National Competent Authorities on Pricing and Reimbursement (NCAPR), which brings together decision-makers from the 27 EU Member States, Iceland, and Norway to discuss pricing and reimbursement of medicines.

Above: The NCAPR gathered in Copenhagen 6 - 7 November 2025.

10 - 12 November 2025 - Crowne Plaza, Copenhagen

At this meeting, PRAC – EMA’s committee for the monitoring of medicinal product safety and thus the central European body responsible for overseeing the safety of medicines throughout the EU – convened.

In addition to contributions from a range of Danish and international stakeholders, the meeting also featured joint discussions on the future of pharmacovigilance and on the strategic cooperation between EU Member States.

Above: PRAC gathered in Copenhagen 10 - 12 November 2025.

17 - 19 November 2025 - Bella Sky, Copenhagen

How do medicines authorities handle misinformation and fake news? This was the central theme of the meeting for communications leads from the medicines authorities of EU member states.

In every country, patient safety is paramount, yet fake news continues to surface everywhere – which is why a joint European effort to uphold facts, accurate information, and trust in health authorities ranks high on the WGCP’s agenda.

To help put the topic into perspective, contributions were made by, among others, Professor Michael Bang Petersen from Aarhus University, who shared insights from his research on the subject.

Above: WGCP gathered in Copenhagen 17 - 19 November 2025.

17 November 2025 - Bella Sky, Copenhagen

During this workshop, the focus was on the future of the Competent Authorities for Medical Devices (CAMD), the network that brings together European regulatory experts in medical devices.

The participants were members of the CAMD Steering Committee, and the workshop followed up on the CAMD meeting hosted by the Danish Medicines Agency in September. At the meeting, participants discussed the next steps to strengthen the network and its role within the regulatory system.

Above: CAMD gathered for workshop in Copenhagen 17 November 2025.

24 November 2025 - The Danish Medicines Agency, Copenhagen

At this meeting, the Danish Medicines Agency’s Director, Nils Falk Bjerregaard, hosted an online session for the circle of directors from the EU member states’ medicines authorities gathered in the HMA. One of the key items on the agenda was the future megatrends in the health sector – and how the medicines authorities in the EU can best navigate them.

The digital meeting should be seen in connection with the physical HMA I meeting held in September.

Above: Virtual HMA-meeting on 24 November 2025

27 November 2025 - the Danish Medicines Agency, Copenhagen

At this virtual meeting, IT directors from the EU’s member states (including Norway) and the management of the EMA’s IT department discussed a work plan aimed, among other things, at building a shared knowledge base for exchanging information on system integration, IT support, digitalisation, and related strategies.

The presentations and subsequent discussion focused in particular on data formats subject to specific requirements when dealing with medicines and associated adverse reactions. The agenda also included contingency planning and crisis management.

Above: Virtual Presidency-meeting with the NICTAC and IT-directors on the 27 November 2025

3 - 5 December 2025 - Scandic Falkoner, Frederiksberg

As the name of the meeting indicates, the focus was on legal matters – including discussions on, among other things, AI and the law, case law, compensation for medicinal product injuries, and a range of other legal aspects of shared interest to the medicines authorities of the member countries.

Above: EMACOLEX gathered 3 - 5 December in Copenhagen

9 - 12 December 2025 - Crowne Plaza, Copenhagen

For around 20 years, this group has brought together police, customs and medicines authorities from across Europe with a shared objective of strengthening the fight against medicines-related crime and protecting patient safety.

The meeting focused on new trends and developments in the illegal trade in medicines, how to safeguard the medicines distribution chain, and how data can be used to monitor and analyse this cross-border crime. In addition, discussions addressed how authorities can inform citizens about avoiding the purchase of illegal medicines – an effort that goes hand in hand with targeted enforcement to stop the illegal trade.

Above: WGEO gathered 9 - 12 December 2025 in Copenhagen