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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 the spring, the Regulatory Affairs Platform will be launching Regulatory Affairs Watch. This email newsletter will be dispatched at regularly intervals to help its readers stay up to date in the field and gain a common understanding of relevant laws and regulatory requirements.

It aims to reach a wide audience: clinical research professionals, trainers, regulators, academics, potential sponsors, patient associations, the media, and members of ethics committees.

Sections will include: headlines and happenings, a “deep dive” on a particular topic, tips and tricks, views and opinions, and upcoming events. Future issues will also be archived online.

For a foretaste of the newsletter, please download the test version (issue 0) below.

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.