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Regulatory Affairs

Each clinical research project must be kept on the right legal track. We make sure that research professionals get the support they need in the ever-changing regulatory environment. We also interact with authorities to find a common understanding of legislation. Our overall aim is to promote the best possible legal framework conditions for clinical research in Switzerland.

Keeping clinical research projects on the right legal track

What we offer:

We keep track of the ever-changing regulatory environment and publish reviewed information for clinical research professionals. We identify challenges in the realm of clinical research regulatory affairs and interact with stakeholders to find the best solutions. In addition, we provide useful tools and guidance documents for smooth processes and for successful ethics and authority approvals.

What challenges we tackle:

Investigators and sponsor-investigators often see regulatory aspects as hurdles impeding clinical research. We aim to offer advice to stakeholders and support to clinical research professionals so that RA activities serve instead as a guarantor of quality and a smooth approval process.

Our key projects:

We regularly publish Regulatory Affairs Watch, our online journal addressing Swiss RA topics for clinical research professionals, investigators, sponsors, regulators, members of ethics committees, professional organisations, and patient associations.

We follow up on current developments as they occur, for example the use of electronic health records (EHR) as source data for case record forms in Switzerland, and we organise roundtables with swissethics and Swissmedic and suggest revisions to documents and templates.

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The minds behind the Regulatory Affairs Platform

The experts in the Regulatory Affairs Platform keep track of current RA topics, revisions of legislation, new standards, and guidelines for clinical research in Switzerland and beyond.

Coordinator

Güliz Vanli Jaccard
CRC Lausanne

Team

Güliz Vanli Jaccard, CRC Lausanne, Coordinator

Güliz Vanli Jaccard, CRC Lausanne, Coordinator

Flavia Amiet, SAKK

Flavia Amiet, SAKK

Claudia Becherer, DKF Basel

Claudia Becherer, DKF Basel

Sonia Carboni, CRC Geneva

Sonia Carboni, CRC Geneva

Samantha Chan, CTU Bern

Samantha Chan, CTU Bern

Laurence Chapatte, SCTO

Laurence Chapatte, SCTO

Elke Hiendlmeyer, CTU St.Gallen

Elke Hiendlmeyer, CTU St.Gallen

Francisca Jörger, CTC Zürich

Francisca Jörger, CTC Zürich

Hélène Maby-El Hajjami, CRC Lausanne

Hélène Maby-El Hajjami, CRC Lausanne

Paola Messina, CTU-EOC Lugano

Paola Messina, CTU-EOC Lugano

Mariarosa Pascale, CTU-EOC Lugano

Mariarosa Pascale, CTU-EOC Lugano

Regulatory Affairs Watch

Get in touch with us

We are your primary contact point for regulatory affairs in the field of clinical research in Switzerland. To receive competent answers to general regulatory affairs questions, contact us at or use the form below.