International Networks (INs)

Our International Networks (INs) support regulatory affairs professionals living and working in a country or region by providing a dedicated forum for discussion and sharing knowledge and information.

The purpose of the INs is to:

  • Develop a local TOPRA networking arm in individual countries 
  • Support TOPRA members living and working in a country and increase the membership community based there 
  • Work cooperatively with other not-for-profit or government organisations and relevant academic institutions 
  • Provide an industry sounding board and opportunity to explore key concerns and experiences 
     

    • Current INs


    Co-Chairs: Frank Vandendriessche and Paula van Hennik


    The Benelux IN group supports TOPRA members who live and work in Belgium, the Netherlands and Luxembourg or have an interest in healthcare regulatory affairs topics relevant to the Benelux. The group was relaunched in 2024, and its vision, mission, objectives and governance principles were agreed in early 2025, which are aligned to those of TOPRA.

    Activities going forward will be enhanced in the following ways:

  • The steering group embers will work on, lead and be present at webinars which are accessible to all TOPRA members (non-member access is subject to a modest charge) and webinars are also available on-demand post-broadcast.
  • There will also be more frequent informal sessions accessible to TOPRA members to encourage networking opportunities.

    Topics that will be covered in 2025 include:
  • The Belgian Federal Agency for Medicines and Health Products (FAHMP/FAGG/AFMPS)
  • The Dutch Medicines Evaluation Board/College ter Beoordeling van Geneesmiddelen (MEB/CBG)
  • The Health Technology Assessment (HTA) Regulation and how it can impact at local company affiliate level
  • The impact of the Clinical Trials Regulation (CTR)
  • A Chemistry, Manufacturing and Controls (CMC) topic – tbc

    • Interested in joining the Benelux IN Steering Group? Please contact gloria.dwyer@topra.org to get involved.

     

     

    Chair: Ekaterina Borcheva-Dancheva
    Co-Chair: Alenka Dražumerič

    The Central Eastern European (CEE) IN group supports TOPRA members who live and work in Bulgaria, Croatia, Czechia, Latvia, Romania and Slovenia
    as well as those with an interest in healthcare regulatory affairs topics relevant to these regions.

    Our current group discussions include:
    • Country representation of TOPRA members across CEE
    • Drug/Biologics/MDD Pre-marketing and post-marketing regulatory challenges.
    • Specific focus on EU Clinical trial and MDD Regulations, CMC, labelling, regulatory frame in CIS countries (and the impact of the ongoing Russo-Ukrainian conflict)
    • Webinars held in EU drug and device regulation changes and in country implementations; herbal medicines; labelling for registered drugs; regulatory rules and updates within the CIS region and non-EU Balkan countries.

    We also have upcoming webinars planned for October and November 2025 on Western Balkan markets and challenges in EU regulatory projects involving combined drug-device studies.

    We're excited to extend participation from regulatory professionals from Albania, Greece, Hungary, Montenegro, North Macedonia, Poland, Serbia and Slovakia.

    Interested in joining the CEE IN Steering Group? Please contact gloria.dwyer@topra.org to get involved.
     

    Chair: Dr Christian Monnerjahn FTOPRA 
    Co-Chair: Dr Inka Gallitz

    TOPRA IN DACH was launched in October 2024 to expand the former TOPRA IN Germany group to a wider IN community dedicated to networking and knowledge sharing for TOPRA members who live and work in Germany, Austria and Switzerland.

    The group’s vision is to support members’ professional development by offering and encouraging participation in activities including:

    • Networking – on a virtual, hybrid and in-person basis; with the possibility of regional “Stammtisch” meetings in the future and informal gatherings  
    • In-depth discussion of current hot topics in regulatory affairs in formats accessible to the whole TOPRA community such as webinars, CPD training courses or publications in TOPRA’s Regulatory Rapporteur and podcasts
    • Collaborations with other TOPRA SPIN and IN groups 

    Topics that will be covered in 2025 include:

    • A visible presence of the group at the TOPRA Symposium in Berlin (29 September – 1 October 2025) with a general presentation of the group and offering a  event open to all interested members elaborating a specific (to be selected) topic in the wide AI area for presentation in an established TOPRA format, e.g. as webinar
    • Evaluating the potential of collaborating with regional regulatory agencies (BfArM, Swiss Medic, BSAG, AGES)  and  organisations specific to regulatory affairs professionals (DGRA, MEGRA) 
    • Establishing a forum for easy access conversations and question on current topics of interests at one-to-one group meetings. 

    If you are interested in joining our dynamic group, please contact gloria.dwyer@topra.org – and make sure you meet us at the Symposium in Berlin! 


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    This IN group supports TOPRA members who are living and working in France.

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    The TOPRA In India group aims to establish a platform for Regulatory professionals within India, whether residing or working there, to exchange knowledge and experiences.

    Comprising members from diverse backgrounds, the steering group convenes quarterly to facilitate various activities such as webinars and round table discussions. These initiatives offer valuable insights and opportunities for newcomers to regulatory affairs.

     

    We welcome suggestions for topics for future webinar topics and activities would like to see organised. If you are interested in becoming a steering group member please contact gloria.dwyer@topra.org. 

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    Chair: Brian Cleary
    Co-Chair: TBC

    TOPRA IN Ireland was established to build a dedicated community for regulatory professionals who live and work across the country. Evolving from previous member initiatives, this group is part of

    TOPRA’s wider IN network, aimed at fostering connection, learning and professional development.

    The vision of TOPRA in Ireland is to empower regulatory affairs professionals by creating opportunities for:

  • Networking and community engagement – Throughout each year, there are numerous opportunities for members to participate in events, network with colleagues in industry and learn from others.  We have a regular schedule of events, and we recently hosted an evening meeting at the HPRA with a variety of speakers looking at the impact of artificial intelligence on the regulatory function. We also run site tours of world class pharmaceutical and medical device plants, and networking events for members. 
  • Regulatory knowledge exchange – Facilitating discussion on emerging topics in regulatory science and policy relevant to Ireland and the broader EU landscape, using accessible formats.
  • Cross-group collaboration – Working with other TOPRA “IN” and “SPIN” groups to promote knowledge sharing, inclusivity and interdisciplinary dialogue across regulatory functions.

    Whether you are working in industry, consultancy, academia or within regulatory authorities, TOPRA in Ireland is an ideal platform to connect, contribute and grow.

    Interested in joining the TOPRA IN Ireland Steering Group? Please contact gloria.dwyer@topra.org to get involved.

     


    • This IN group supports TOPRA members who are living and working in Scotland.

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    This IN group supports TOPRA members who are living and working in Sweden.

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    Upcoming TOPRA In events

    Start dateTitleDescriptionCityCountry
    17/09/2025TOPRA IN Sweden: Different Forms of Advice ProceduresDuring the development of new medicines or medical devices, a dialogue with various authorities is an important factor for success. There are many forms of advice both nationally and centrally. This evening is an excellent opportunity to hear experiences of different forms of advice. We will hear about the processes that exist for medicines nationally in Sweden and other EU countries, centrally with the EMA and FDA, as well as the opportunities that exist for medical devices and combination products. We also get to hear some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to anyone who works with and is interested in regulatory affairs. SwedenSWESEP25
    12/11/2025The Role of Real-World Evidence in Health Technology DevelopRegistration is now open for TOPRA in Scotland's final meeting of 2025 to be held at the ACD Centre.  Join us, and our expert speakers, as we discuss the role of real-world (RWE) evidence in health technology development. RWE continues to gain prominence as a tool in health technology development with developers and regulators both looking to leverage the insights it can offer to support alternative pathways to market - whether it is through external control arms or post-launch evidence generation - there's a lot to be aware of.  Despite this, the regulatory considerations around RWE are often misunderstood.  Join us and our expert speakers as we look to remove some of these misunderstandings with our expert speakers.EdinburghUnited KingdomSCONOV25

    Get involved

    We are developing more IN communities and if you would like to find out more or get involved with setting up a group, please email our membership team.