Write a Feature article for October’s Regulatory Focus

RAPS is looking for authors for the October 2023 issue of Regulatory Focus, which publishes monthly in-depth, evidence-based content on emerging issues in the global regulatory landscape.

Articles for the issue will focus on the EU Clinical Trial Regulation, which went into effect on 31 January 2022. The Regulation aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. Prior the Regulation, sponsors needed to submit clinical trial applications separately to national health authorities and ethics committees in each country to get regulatory approval to run a clinical trial. The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.

The articles will go over the Regulation itself and provide examples of experiences with working under the Regulation, including the CTIS. Topics could include, but need not be limited to:

• Elements of the Regulation
• Case studies of working under the Regulation
• Practical information on working with the CTIS

Article submissions are due 1 September 2023.

Read the Guidelines for Authors to learn more about Regulatory Focus peer-reviewed articles and how to submit an article. For more information, email rmatthews@raps.org

Prospective authors should be regulatory professionals with expertise or a focus in the topic area.