Communities

One of the main reasons for joining TOPRA is to network with other regulatory affairs professionals from all over the world. Our communities provide our members with opportunities to exchange news, views and ideas and are segmented by region (International Networks or INs) and topic (Special Interest Networks or SPINs).  

You can access them by logging in below or through our TOPRA Engage app.

 

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Watch our short videos below to learn how to get started with our online platform, keep up to date and get the most out of our communities.

Getting started Keeping up to date Getting involved
     

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 aim 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
  • Current INs


    This IN group supports TOPRA members who are living and working in Belgium, the Netherlands and Luxembourg.

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

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

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

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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 membership@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 North America. 

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

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    Upcoming TOPRA In events

    Start dateTitleDescriptionCityCountry
    17/09/2024TOPRA in Sweden: Combination ProductsDevelopment of combination products or when drugs and medical devices and/or in vitro medical devices are combined, have its own special challenges. An EU common regulation 536/2014 (also called Clinical Trials Regulation, CTR) applies to clinical trials of medicinal products for humans. A single application for the drug is sent to an EU-wide web portal and database (CTIS) and results, after an EU-wide investigation process, in a national decision. For a combined clinical investigation, the medical device or in vitro medical device must be applied for and approved nationally using different processes in different EU countries. We will hear how different combination products are handled to regulatory approval, about COMBINE, a project to facilitate combined studies, about what rules and guidelines exist and practical experiences. 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.LundSwedenSWESEP24

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    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.

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