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
    •  
    We will also be present at Regulatory Careers Live in Brussels, Belgium on 13 June 2025.

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

     

     

    This IN group supports TOPRA members who are living and working in Central and Eastern Europe. The CEE group was established in 2020, and has members from Bulgaria, Croatia, Latvia, Romania and Slovenia. 

    The group has hosted a number of presentations since 2020 including:

  • EU drug & device regulations changes and country implementations (TOPRA Symposium and webinar, 2020).
  • Herbal medicines (2021)
  • Labelling for registered drugs (2022)
  • Regulatory Challenges in the CIS and Russia (2023)

    • Objectives for 2024 include organising a webinar on medicinal products registrations in non-EU Balkan countries,

    The group also aims to collaborate with other SPINs in the areas of MD/IVDR, CMC and labelling.

    Steering committee members 
  • Ekaterina Zareva Borcheva-Dancheva
  • Alenka Drazumeric
  • Tatjana Bekavac
  • Polina Dombure
  • Dobrinka Ouzounova
    •  
     

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

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    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
    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.