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Associate members

The SCTO is an independent organisation and is based on a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.

As of 2017, the SCTO is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.

Regulatory Affairs

Coordination

Dr Laure Vallotton, Centre Hospitalier Universitaire Vaudois, CTU Lausanne

SCTO Regulatory Affairs Platform

Keep up to date with Regulatory Affairs Watch

In April 2019, the Regulatory Affairs Platform has launched its newsletter, Regulatory Affairs Watch.

It aims to reach a wide, national audience: human research professionals, investigators, (potential) sponsors, regulators, members of ethics committees, professional organisations and patient associations.

This email newsletter will share, at regular intervals, news of a scientific and regulatory nature, from Switzerland and abroad: articles, events and publications. Furthermore, each issue will feature a deep dive on a particular topic, accompanied by views and opinions of different organisations. The newsletter is published in English only.

The latest issue of April 2019 appears below, followed by the newsletter archives.

Hot off the press

Issue 1, April 2019

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Newsletter archives

Issue 0, December 2018

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Regulatory Affairs in brief

Regulatory affairs is a relatively new professional field. It emerged in the 1980s, when governments worldwide became compelled to better protect the public. Such protection includes ensuring that all medicines reaching society are optimally safe and effective. Regulatory professionals were developed to integrate sound regulatory practices into projects from start to finish, keeping them on the right legal track.

In the realm of clinical research, they assist their peers with clinical trials applications, from early days, ensuring that all the documents and processes accompanying a project are in place and are of the quality required. Regulatory affairs professionals assist in reviewing study plans (protocol) and preparing submissions to national authorities, amending as needed, placing the trial in a registry, and following it through with the final study reports. All documents must be reviewed, complete, scientifically accurate, in regulatory compliance, and presented so as to facilitate the review and approval process of the ethics committees and – if needed – of the competent authorities.

Would you like to know how the experts in the Regulatory Affairs Platform are channeling their efforts? For more information, consult the fact sheet below.