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Regulatory Affairs (RA) Watch 5 – COVID-19
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Regulatory Affairs | Human Research Act - HRA | Article
Reviews on how SCTO Network, SNSF, Swissmedic, and swissethics, responded to the COVID-19 crisis, supported studies, protected patient rights, and what lasting lessons and innovations may shape the post-pandemic future.
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Regulatory Affairs (RA) Watch 6 – Patient and public involvement (PPI)
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Regulatory Affairs | Human Research Act - HRA | Article
Overview of active
Swiss stakeholders on PPI and how PPI is promoted in clinical research.
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Regulatory Affairs (RA) Watch 7 – Data privacy and data sharing in clinical research
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Regulatory Affairs | Data protection | Article
DATA PRIVACY AND DATA SHARING WITHIN THE REGULATORY FRAMEWORK GOVERNING HUMAN, HEALTH-RELATED
RESEARCH IN SWITZERLAND
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Regulatory Affairs (RA) Watch 8 – Experiences with 2021 changes to MD regulatory framework
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Regulatory Affairs | Human Research Act - HRA | Article
NAVIGATING THE 2021 CHANGES TO THE MEDICAL DEVICE REGULATORY FRAMEWORK
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Regulatory Affairs (RA) Watch 9 – Innovation in clinical research: Decentralised and complex trials
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Regulatory Affairs | Study Management | Article
DECENTRALISED AND COMPLEX CLINICAL TRIALS: SHAPING THE FUTURE OF CLINICAL RESEARCH. Opportunities and challenges
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Revision of the Human Research Act (HRA) ordinances – Impact on projects approved before 1 November 2024
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Regulatory Affairs | Human Research Act - HRA | Education & Training
The revised 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.
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The new Federal Act on Data Protection (nFADP): Guidance for clinical trials
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Regulatory Affairs | Data protection | Guidelines & Publications
Short guide explaining whether the new Federal law on data protection (FADP) is relevant for your clinical research project and what the most important changes are as compared to the old FDAP.
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