News and Educations

Strength in Collaboration: Highlights from the IncreaseNET 2025 Assessors Forum

06.02.2025

On January 30, 2025, Zagreb, Croatia, became the vibrant hub of regulatory expertise as the IncreaseNET 2025 Assessors Forum: Enhancing NCAs Expertise gathered 180 participants, both in-person and online, from 25 EU/EEA countries, Ukraine, as well as representatives from the European Medicines Agency (EMA) and the European Commission's DG Sante. This dynamic event showcased the transformative power of collaboration within the European Medicines Regulatory Network (EMRN).

A Unified Welcome

The forum opened with a welcome address from Siniša Tomić, Executive Director of HALMED¹, which hosted the event, and Momir Radulović, Executive Director of JAZMP², which coordinates IncreaseNET. They highlighted not only the forum’s significance as a unique platform for targeted networking and collaboration within the EMRN but also the vital role of the IncreaseNET project itself in enhancing regulatory expertise across national competent authorities. Both speakers underscored the importance of hands-on learning experiences in strengthening skills and knowledge within the network.

Building on their remarks, Luka Kosec, IncreaseNET’s Coordinator (JAZMP), provided an overview of the IncreaseNET, outlining key objectives and achievements to date. He also emphasized the crucial role of active engagement from all consortium partners in ensuring the project's success and maximizing its benefits for everyone involved.

Key Sessions: Navigating the Present, Shaping the Future

• The Journey of EU NTC: Origins, Achievements, and the Road Ahead with IncreaseNET: Marianne Van Heers (EMA) presented the evolution of EU Network Training Centre (EU NTC) since its inception in 2014, detailing how training programs are planned, designed and delivered. She showcased the EU NTC platform and newsletter, outlined priorities for 2025, and emphasized the close collaboration with IncreaseNET - both striving for harmonized, high-quality assessment standards. She closed with an inspiring message: "Happy Learning” to all.

• Collaborating for Sustainability: Steffen Bager and Niels Henrik Meedom (DKMA³) explored how sustainability will be embedded into IncreaseNET’s work to ensure lasting impact for the EMRN. They emphasized the need to integrate sustainable practices into all activities, deliverables and milestones from the outset, ensuring that results extend beyond the project’s duration. They also highlighted the crucial role of collaboration with the EU NTC in maintaining and strengthening IncreaseNET’s impact over time.

• National Competent Authorities (NCAs) Capacity Survey Results: Marko Kallio (FIMEA⁴) presented the development, timeline and key findings of the NCA Capacity Survey conducted in 2024. He outlined plans for a follow-up survey (approx. month 30) to assess progress during the project. The survey’s purpose includes mapping NCAs’ expertise, resource needs and knowledge gaps, cooperation practices, reliance on external experts, and training needs related to innovation.

• Training Redefined: Building the Path to Effective Learning: Naomi Beard (HPRA⁵) presented IncreaseNET’s work on training development, reflecting on why training matters, how it is designed and what has been learned during the project’s first year. She explored key challenges, future plans and the overall vision for shaping high-quality training programs. She introduced the IncreaseNET training development roadmap, outlining the journey from assessing learning needs to designing courses, recruiting topic experts, implementing training, and evaluating its effectiveness. Acknowledging the importance of collaboration, she highlighted the valuable contributions of EMA and HMA working groups and committees (CAT⁹, BWP¹⁰, CTCG¹¹, MWP¹² - to name a few), whose expertise strengthens the program’s foundation.

• One year in action: Progress, practice and potential of the IncreaseNET's on-the-job training & coaching program: Anna Nickel (BfArM⁶) provided a detailed visual representation of the different roles trainees and mentors can choose based on their needs and availability, explaining who can be involved and in what capacity. She also shared data and analysis on program participation. Yasmine Labrak’s (FAMHP⁷) personal insights as a trainee in the program brought a relatable, human touch to the discussion, highlighting both achievements and areas for growth.

• AI for medicines regulation: Gabriel Westman (Swedish MPA⁸) addressed the evolving role of AI in medicines regulation, presenting work done by the Swedish agency in this field. He introduced the AI@MPA toolbox, a secure, cloud-based platform designed to support regulatory activities, currently accessible to 17 NCAs. He also discussed the scientific foundations of natural language processing, generative AI, and computer vision, emphasizing that while AI has potential in data assessment, its broader integration into NCAs' work is still under development.

Why Collaboration Matters

The forum wasn’t just about sharing IncreaseNET’s updates; it exemplified how cooperation accelerates progress. The diverse mix of participants, ranging from clinical, non-clinical and quality assessors to scientific experts, fostered dynamic discussions and led to actionable insights.

As IncreaseNET continues its journey, the message from Zagreb is clear: collaboration isn’t just beneficial, it’s essential. Together, national competent authorities can build a resilient, forward-thinking regulatory landscape that ensures safe, effective and high-quality medicines for all.

For more information on IncreaseNET, visit the IncreaseNET Project Page.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.

¹ Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Croatia

² Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), Slovenia

³ Danish Medicines Agency (DKMA), Denmark

⁴ Finnish Medicines Agency (FIMEA), Finland

⁵ Health Products Regulatory Authority (HPRA), Ireland

⁶ Federal Institute for Drugs and Medical Devices (BfArM), Germany

⁷ Federal Agency for Medicines and Health Products (FAMHP), Belgium

⁸ Swedish Medical Products Agency (Swedish MPA), Sweden

⁹ Committee for Advanced Therapies (CAT)

¹⁰ Biologics Working Party (BWP)