Regulatory Affairs Watch
Key insights into current regulatory topics
Regulatory Affairs Watch is published annually, with each issue focusing on a current regulatory topic. A range of clinical and academic experts, regulatory authorities, patient advocates, legal experts, and industry stakeholders contribute articles sharing their perspectives on and experience with the topic. Each issue also includes a case study illustrating practical aspects of the topic as well as current regulatory news, events, and publications.
Discover the Tools and Outcomes of the Regulatory Affairs Platform.
Recent Publications
RA Watch 11 | Artificial intelligence in clinical research
October 2026
Editor: Güliz Vanil Jaccard
The eleventh issue of Regulatory Affairs Watch explores opportunities and challenges related to using artificial intelligence in clinical research and surveys the evolving regulatory landscape. Through expert perspectives and practical examples, it addresses related ethical and legal considerations, patient and public involvement, medical device software, and applications in clinical trials.
Articles in this issue:
Exploring new territory: Various perspectives on AI in clinical research and its impact on the regulatory landscape
Author: Güliz Vanli Jaccard
AI in action in clinical research: Applications, limitations, and the emerging regulatory framework
Authors: Fanny Muet, Güliz Vanli Jaccard
From health software to artificial intelligence in medical devices: Navigating the regulatory landscape
Author: Einat Albers-Schönberg
Ethical challenges related to artificial intelligence in clinical research
Author: Pietro Gervasoni
AI in clinical research: Regulatory and legal uncertainties in protecting participants’ rights
Author: Audrey Lebret
From smarter algorithms to more patient-centric trials: Balancing AI innovation and the patient perspective in clinical research
Author: Christine Jacob
Incorporating artificial intelligence into clinical trial management
Author: Lara Bernasconi
Large language models in clinical research: Risks and opportunities
Author: Benjamin V. Ineichen
When a product’s architecture absorbs regulation: Building artificial intelligence and privacy by design into a contactless patient monitoring system
Authors: Cyrill Gyger, Jonas Reber
Regulatory News, Events, and Publications
RA Watch 10 | ICH GCP E6(R3): How it impacts clinical research in Switzerland
September 2025
Authors: Güliz Vanli Jaccard (ed.), Fady Fares, Pietro Gervasoni, Fanny Muet
The third version of ICH GCP E6 represents a significant shift in how quality, risk, oversight, and governance are approached in clinical research. This issue of RA Watch focuses on the impact of the revised regulation on clinical research in Switzerland. It looks at the regulation’s history and the rationale behind the latest revision, includes feedback from Swiss authorities, and examines the regulation’s new data governance section. In order to keep up with the rapid pace of these regulatory changes, this issue was published as a leaner Express Edition.
RA Watch 9 | Innovation in research: Decentralised and complex trials
December 2024
Authors: Güliz Vanli Jaccard (ed.), Alain Amstutz, Gabriel Avigdor, Brenda Bogaert, Aurélie Fayet, Simone Ferbitz-Scheurer, Felix Gerber, Nicole Gusset, Reto Iannaccone, Lada Leyens, Christof M. Schönenberger, Elizabeth Theogaraj, Jamie Wingate, Grégoire Wuerzner
Decentralised and complex trials are now being adopted across many therapeutic areas thanks to their patient-centric focus and research efficiency. This RA Watch issue looks at both the promising and challenging developments in innovative clinical trial approaches and designs. It includes input from Swiss authorities as well as ethics, industry, legal, and patient advocacy stakeholders. A case study shows how a novel study design is being used to overcome some of the challenges trials face.
RA Watch 8 | Experiences with the 2021 changes to the medical device regulatory framework
June 2023
Authors: Marc Froissart (ed.), Steven Bourke, Daniel Delfosse, Shanaz Diessler, Simone Frank, Paul Franken, Pietro Gervasoni, Hélène Maby-El Hajjami, Yvonne Nägelin, Isabel Scuntaro, Catherine Simonin
The medical device (MD) regulatory changes in 2021 raised a multitude of questions. In this issue of RA Watch, stakeholders reflect on the experience they have accumulated with the new MD regulations and comment on challenges they still face. Regulatory authorities, industry stakeholders, patient advocates, and legal experts offer their perspectives, and a case study illustrates a practical approach to study categorisation challenges.
RA Watch 7 | Data privacy and data sharing in clinical research
June 2022
Authors: Isabelle Guilleret (ed.), Claudia Becherer, Matthias Briel, Eva Brombacher, Sonia Carboni, Samantha Chan, Philipp do Canto, Marc Engelhard, Denis Falcetta, Marc Froissart, Angèle Gayet-Ageron, Jose Benito Gonzalez Lopez, Alex Ioannidis, Hélène Maby-El Hajjami, Pedro Marques-Vidal, Taulant Muka, Lars Holm Nielsen, Virgilia Rumetsch, Tim Smith, Sven Trelle
Sharing data in clinical research is a balancing act due to the sensitve nature of the data, privacy regulations, and the enormous potential benefits. This RA Watch issue provides an overview of regulations, guidelines, documents, and templates that apply and/or can help researchers make decisions about data privacy, data sharing, and the further use of data from clinical studies, trials, and routine clinical practice. It includes articles from regulatory, legal, and industry stakeholders as well as a case study illustrating a researcher’s experience with sharing real-world data.
RA Watch 6 | Patient and public involvement (PPI) in human research
October 2021
Authors: Séverine Méance (ed.), Thomas Agoritsas, Claudio Bassetti, Neil Bertelsen, Henri Bounameaux, Nicholas Brooke, Sonia Carboni, Matteo Coen, Tourane Corbiere, Maria Dutarte, Deborah Eberle, Nadia Elia, Anouk Fricker, Marc Froissart, Angèle Gayet-Ageron, Jan Geissler, Pietro Gervasoni, David Haerry, Marie Mi Bonde Hansen, Angela Huttner, Lukas Jaggi, Estelle Jobson, Madlen Korneli, Cordula Landgraf, Olivier Menzel, Rosine Mucklow, Aurélie Perret, Klara Posfay Barbe, Marina Roggo, Marie-Jose Roulin, Caroline Samer, Caecilia Schmid, Deborah Studer, Therese Stutz Steiger, Myriam Tapernoux, Sylvie Touveneau, Carolin von Schoultz, Gabriela Zenhäusern
Patient and the public involvement (PPI) in research not only makes clinical trials possible but also holds great potential to improve trial design, recruitment, conduct, reach, and communication. This issue of RA Watch looks at regulatory aspects of PPI, includes stakeholders’ experiences with PPI, highlights the practical benefit of PPI a case study, and introduces the SCTO’s new national PPI project.
RA Watch 5 | COVID-19
March 2021
Authors: Séverine Méance (ed.), Claudia Becherer, Sonia Carboni, Aurélie Fayet-Mello, Simone Ferbitz-Scheurer, Angela Huttner, Irene Knüsel, Annette Magnin, Alexander Mion, Caecilia Schmid, Madeleine Vollmer, Pascal Walther, Loane Warpelin-Decrausaz, Stéphanie Wyss, Marc Zbinden
Nothing has remained untouched by COVID-19, including clinical research. This RA Watch issue reflects on the lessons learned so far from the pandemic that are related to the regulatory aspects of human research. It looks at how the SCTO’s CTU Network has supported research efforts during the pandemic, how stakeholders have responded, how patients have been affected, and how the authorities have adapted as a result of the pandemic.
RA Watch 4 | Medical registries
October 2020
Authors: Séverine Méance (ed.), Philipp do Canto, Pietro Gervasoni, Elke Hiendlmeyer, Francisca Jörger, Agnes Nienhaus, Julia Parafita, Adrian Spoerri, Nicole Steck, Marcel Zwahlen
Increasingly more research projects are linked to medical registries (MRs), underscoring their value as a research tool. This RA Watch issue analyses how MRs are regulated and supported in Switzerland, takes a look at specific registries, and highlights an example of successful registry governance.
RA Watch 3 | General consent
March 2020
Authors: Séverine Méance (ed.), Julia Bielicki, Sonia Carboni, Philipp do Canto, Susanne Driessen, Julia Maurer, Agnes Nienhaus, Christiane Pauli-Magnus, Klara M. Posfay-Barbe, Cindy Roth, Pascale Wenger
The Swiss Human Research Act requires general consent (GC) for the further use of data and samples for research projects. There has been much activity in this area due to the increased use of health-related data and samples from large patient populations. This issue of RA Watch provides an overview of the recent developments related to GC, gathers stakeholders’ perspectives, and contains a case study on GC in paediatrics.
RA Watch 2 | Medical devices
October 2019
Authors: Séverine Méance (ed.), Claudia Becherer, Mariagrazia Di Marco, Susan Driessen, Marc Froissart, Pietro Gervasoni, Olivier Goarnisson, Elke Hiendlmeyer, Estelle Jobson, Josefine Sommer, Peter Studler, Swiss Medtech, Karen Topaz Druckman, Laure Vallotton, Madeleine Vollmer, Pascale Wenger
The research community is preparing for the upcoming changes in the EU’s and Switzerland’s medical device regulations. This RA Watch issue helps readers better understand how the more stringent regulatory requirements will affect clinical evaluations and investigations of medical devices in Switzerland. Key stakeholders from the SCTO, its network of clinical trial units, swissethics, and the medical technology industry share their views and opinions on the topic. A case study of an app illustrates how demanding the new rules may be for investigators.
RA Watch 1 | EU'S General Data Protection Regulation (GDPR)
April 2019
Authors: Séverine Méance (ed.), Marc Froissart, Christina Huf, Estelle Jobson, Laure Vallotton, Pascale Wenger
With the GDPR now in force, Switzerland faces substantial regulatory changes. This issue of RA Watch addresses relevant and concrete questions about how the GDPR will impact clinical research.