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SCTO Tools & Resources Navigator

Regulatory Affairs Platform

Navigating Complexity. Ensuring Compliance.

The SCTO Regulatory Affairs Platform supports compliance, efficiency, and transparency in academic clinical research in Switzerland. Through cross-institutional collaboration and expert working groups, it provides practical tools and clear guidance to help researchers navigate evolving regulatory requirements and apply them effectively in their projects. Acting as the natural point-of-contact with the regulatory authorities, the platform strengthens communication, fosters alignment and promotes harmonised approach across the SCTO Network.

View all Regulatory Affairs Tools

The Regulatory Affairs Platform has set three main objectives for 2025–2028, supported by several key projects.
We invite you to contact us at regulatoryaffairs@scto.ch if you would like to learn more.

Advocate for a Favorable Legal and Regulatory Framework for Clinical Research

The Regulatory Affairs Platform supports a favourable and transparent regulatory environment for academic clinical research in Switzerland. As the natural point-of-contact for regulatory authorities within the SCTO Network, the platform ensures alignment and keeps researchers informed about evolving requirements. 

Roundtable Discussions with swissethics and Swissmedic  

These exclusive meetings connect the SCTO Network with regulators, providing insights on upcoming changes, fostering collaboration, and promoting transparency.

Regulatory Strategy and Support for the SCTO Network  

This initiative unites three key activities of the Regulatory Affairs Platform: participation in public consultations, ad hoc support on regulatory changes, and horizon scanning for upcoming changes. Through these activities, the Regulatory Affairs Platform empowers the SCTO Network to anticipate development, respond effectively to evolving requirements, and maintain alignment with regulatory expectations.

Provide Operational Regulatory Support Throughout Clinical Research

The Regulatory Affairs Platform supports researchers in the practical application of evolving regulatory requirements throughout the conduct of clinical research. This includes guidance on data protection and the responsible handling of sensitive data.

Guideline on Data Protection in Clinical Research 

We aim to improve data privacy awareness and compliance by delivering tailored, up-to-date guidance that helps clinical researchers protect participant’s data. 

Educate the SCTO Network on Evolving Regulatory Topics

To continuously educate the SCTO Network on evolving regulatory topics, and to ensure up-to-date knowledge and compliance, the RA Platform promotes the following project:  

Publication of “Regulatory Affairs Watch – RA Watch” 

A well-established, theme-based publication, published regularly, providing in-depth coverage of key regulatory developments, complemented by feedback from regulators, expert views and opinions, and case studies from practice. In addition, the new RA Watch Express offers a more agile format to deliver timely updates on emerging and time-sensitive regulatory topics.

Here is an overview of important work done by the Regulatory Affairs Platform in recent years. 
All tools are also searchable in the SCTO Tools & Resources Navigator at the top of this page.

Regulatory Affairs Watch is a theme-based newsletter launched by the SCTO’s Regulatory Affairs Platform in April 2019. It provides insights into key regulatory topics in clinical research in Switzerland and abroad.

SCTO Regularity Affairs Platform

Short guide explaining whether the Federal Act on Data Protection (FADP) is relevant for your clinical research project and what the most important changes are compared to the old FDAP.

🔗The new Federal Act on Data Protection (nFADP): Guidance for Clinical Trials

SCTO Regularity Affairs Platform

Overview of the most significant changes in the Human Research Act (HRA) ordinances in 2024, with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO).

  • Online Seminar: HRA Ordinances – What Has Changed?
     Presentation of the most significant changes in the new HRA ordinances in 2024, with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO)

    SCTO Presentation, HRA Presentation, Video and Q&A


SCTO Regularity Affairs Platform

The revised Revision of the Human Research Act (HRA) ordinances came into force on 1 November 2024, with the new transparency rules taking effect on 1 March 2025. This document, prepared by the SCTO Regulatory Affairs Platform, outlines the impact of the revised ordinances on projects approved prior to 1 November 2024.

🔗 Revision of HRA ordinances: Impact on projects approved before 01.11.2024

SCTO Regularity Affairs Platform

Since 2015, the SCTO RA Platform is organising the annual Roundtable with swissethics and Swissmedic. This key event enables the SCTO Network to:

  • Engage directly with regulatory authorities
  • Gain early insights into upcoming regulatory changes
  • Exchange on opportunities and challenges for the network

Each year, the RA Platform collects topics and questions from across the network, structures the agenda for a focused and strategic discussion and facilitates meaningful dialogue and impactful outcomes.

SCTO Regularity Affairs Platform

From 31 January 2025, all EU clinical trials must be managed via the Clinical Trials Information System (CTIS) under the European Clinical Trial Regulation (CTR).

To support Swiss investigators in this transition, members of the Regulatory Affairs and Safety Platforms have completed key trainings, including:

    • The CTIS sponsor end-user programme
    • EudraVigilance hands-on sessions

These activities strengthened the expertise within the Network and now provide a solid basis to support investigators working with the CTIS. 

For questions, please contact us. Email: regulatoryaffairs@scto.ch

Meet the Platform Team

Meet the individuals whose expertise and collaboration drive each Platform forward. Together, they help strengthen clinical research across Switzerland through shared knowledge, leadership, and innovation.

Güliz Vanli Jaccard – Coordinator, CRC Lausanne
Fanny Muet – Member, CRC Lausanne
Hélène Maby-El Hajjami – Contributor, CRC Lausanne
Cristina Boehm-Bosmani – Member, CRC Geneva
Francisca Jörger – Member, CTC Zürich
Sabina Tresch –   Contributor, CTC Zürich
Zoé Peña Aguirre – Member, DCR Bern
Elke Hiendlmeyer – Member, CTU HOCH St.Gallen
Paola Messina – Member, CTU-EOC Lugano
Claudia Becherer – Member, DKF Basel
Kristin Shrestha – Contributor, DKF Basel
Stephanie Spannl – Contributor, DKF Basel
Flavia Amiet – Voluntary Contributor, Swiss Cancer Institute
Laurence Chapatte – Scientific Affairs Manager & Liaison Officer, SCTO

Güliz Vanli Jaccard

Coordinator, CRC Lausanne

Claudia Becherer

Member, DKF Basel

Cristina Boehm-Bosmani

Member, CRC Geneva

Elke Hiendlmeyer

Member, CTU HOCH St.Gallen

Francisca Jörger

Member, CTC Zürich

Paola Messina

Member, CTU-EOC Lugano

Fanny Muet

Member, CRC Lausanne

Zoé Peña Aguirre

Member, CTU Bern

Laurence Chapatte

Scientific Affairs Manager & Liaison Officer

Other Platform Contributors

Güliz Vanli Jaccard – Coordinator, CRC Lausanne
Claudia Becherer – Member, DKF Basel
Cristina Boehm-Bosmani – Member, CRC Geneva
Elke Hiendlmeyer – Member, CTU HOCH St.Gallen
Francisca Jörger – Member, CTC Zürich
Paola Messina – Member, CTU-EOC Lugano
Fanny Muet – Member, CRC Lausanne
Zoé Peña Aguirre – Member, CTU Bern
Laurence Chapatte – Scientific Affairs Manager & Liaison Officer

Flavia Amiet – Voluntary Contributor, Swiss Cancer Institute
Hélène Maby-El Hajjami – Contributor, CRC Lausanne
Kristin Shrestha – Contributor, DKF Basel
Stephanie Spannl – Contributor, DKF Basel
Sabina Tresch –   Contributor, CTC Zürich