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HRA Ordinance Revision 2024/2025: Comparing old and new requirements
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Education & Training | Education & Training | Information Exchange
This document provides a practical overview of key changes introduced in the revised HRA ordinances.
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HRO Lunch Session Material - BASEC: A practical walk-through for HRO projects
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Education & Training | Education & Training | Seminar
Practical guidance on observational study submission through the BASEC portal in line with HRO Chapter 2 and a further use project according to HRO Chapter 3.
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HRO Lunch Session Material - Mastering Consent: Key insights into general and informed consent for HRO projects
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Education & Training | Education & Training | Seminar
Overview of the legal and ethical requirements for the secondary use of data and samples, and how and when general consent can be used
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HRO Lunch Session Material - Quality: Law, practice and common hurdles
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Education & Training | Education & Training | Seminar
Legal basis of quality aspects of a research project with examples on how to keep the quality of projects high.
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Online seminar: HRA ordinances - what has changed?
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Regulatory Affairs | Education & Training | Seminar
Presentation by swissmedic and Swissethic on the overview of the most significant changes in the new HRA ordinances in 2024 with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO).
Regulatory Affairs (RA) Watch 1 - EU GDPR
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Regulatory Affairs | Guidelines & Publications | Article
Issue on data protection in human research
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Regulatory Affairs (RA) Watch 10 – ICH GCP E6(R3): How it impacts clinical research in Switzerland
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Regulatory Affairs | Guidelines & Publications | Article
Impacts of the new ICH GCP E6(R3) on clinical research in Switzerland
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Regulatory Affairs (RA) Watch 2 – Medical Devices
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Regulatory Affairs | Guidelines & Publications | Article
Issue on Regulatory changes coming from the EU and the ongoing revisions of Swiss laws regarding medical devices.
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Regulatory Affairs (RA) Watch 3 – General Consent
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Regulatory Affairs | Guidelines & Publications | Article
Deep dive in the general consent implementation in Switzerland and the challenges around it
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Regulatory Affairs (RA) Watch 4 – Medical Registries
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Regulatory Affairs | Guidelines & Publications | Article
medical registries (MRs) as a research tool what are the opportunities and the challenges
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