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 are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Interested in joining the Benelux group? Please contact communities@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:
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Country representation of TOPRA members across CEE
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Drug/Biologics/MDD Pre-marketing and post-marketing regulatory challenges.
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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)
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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.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at
communities@topra.org.
Interested in joining the Central & Eastern Europe group? Please contact
communities@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:
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Networking – on a virtual, hybrid and in-person basis; with the possibility of regional “Stammtisch” meetings in the future and informal gatherings
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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
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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.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at
communities@topra.org.
Interested in joining the DACH group? Please contact
communities@topra.org to get involved.
Chair: Gabriel Bohl
The TOPRA IN France group supports TOPRA members who live and work in France and have an interest in healthcare regulatory affairs topics relevant to the region.
The group’s vision, mission, objectives, and governance principles, agreed in early 2025, are fully aligned with those of TOPRA.
Future activities will include:
• Discussing regulatory updates in France and internationally, sharing case studies, addressing questions, and exchanging regulatory experience
• Organising webinars and face-to-face meetings on selected topics of interest
• Establishing working groups for specific regulatory themes to encourage collaboration and knowledge sharing.
Join the TOPRA IN France network to connect with peers, share expertise, and contribute to discussions that shape regulatory practice in the region.
Interested in joining the French group? Please contact communities@topra.org to get involved.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Chair: Abhishek Sinha
Co-Chair: Anoop Mishra
After five years, TOPRA IN India continues to represent the Indian regulatory affairs community globally. Our mission remains focused on enhancing awareness of the fast-evolving Indian regulatory framework and fostering meaningful international engagement.
The Indian pharmaceutical industry is a major global player, ranking third in volume and fourteenth in value as per data from the Department of Pharmaceuticals published in 2024. The Indian generics industry holds approximately 20% of global market share by volume.
In this context, TOPRA IN India provides a collaborative platform for emerging and established regulatory professionals to exchange ideas and information with the wider TOPRA community.
Our activities over the past years have included:
- Webinars addressing key regulatory topics
- Joint initiatives with TOPRA SPINs for information sharing
- Contributions to TOPRA’s Regulatory Rapporteur through insightful articles
- Successful in-person events – one held with Association of Regulatory Affairs Professionals (ARAP) and a recent collaboration with Informa in Mumbai.
As we move forward, the aim is to further strengthen ties with our global partners and continue shaping conversations on regulatory evolution.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Interested in joining the India group? Please contact communities@topra.org to get involved.
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.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Interested in joining the Ireland group? Please contact communities@topra.org to get involved.
This IN group supports TOPRA members who are living and working in Scotland.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Interested in joining the Scotland group? Please contact communities@topra.org to get involved.
This IN group supports TOPRA members who are living and working in Sweden.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.
Interested in joining the Sweden group? Please contact communities@topra.org to get involved.
Chair: Carlos Germán Nocera Lacave
The TOPRA IN group aim to lead the establishment of a network of professionals interested in regulatory affairs in Spain, fostering growth, development, and expansion in line with the criteria and guidelines set by TOPRA Communities policy.
• Coordinate the activities of active members and encourage the participation of new ones
• Provide a forum for discussion and exchange of experiences, knowledge, ideas, and advice, as well as trends and updates on regulatory topics
• Serve as a link with TOPRA Academy for academic training and continuous professional development activities
• Build relationships with other industry organisations that align with TOPRA's initiatives and values
• Support TOPRA initiatives in Spain and, by extension, across the Spanish-speaking world.
Our mission is to facilitate the introduction of safe and efficient healthcare technologies into healthcare systems, translating technical knowledge into market value and connecting science with business.
We focus on:
• Ensuring regulatory compliance
• Promoting strategic collaborations
• Building trust and creating social impact
• Developing ethical pharmaceutical communication and marketing aligned with regulations.
Interested in joining the TOPRA IN Spain group? Please contact communities@topra.org to get involved.
We are developing more IN communities. If you would like to find out more or get involved with setting up a group, please email our Communities team at communities@topra.org.