Ensuring the critical steps to reach the patient are integrated effectively
The Quality Assurance, Clinical and Regulatory Affairs team works closely with our technology development teams and ensures execution of critical translation steps such as fulfillment of product requirements, clinical protocol development, regulatory compliance and submissions.
The team’s efforts are paramount towards ensuring that the innovations being pursued at the Wyss Center are deployed safely to the patient and gain appropriate regulatory and clinical trial approval from relevant authorities in Switzerland, the European Union and the US.
Key areas in Regulatory Affairs
- Up to date knowledge and advice on evolving regulatory requirements and standards affecting neuroscience and neurotechnology research and development
- Compliance adherence to all regulations and laws pertaining to research and development projects at the Wyss Center
- Engagement with Swiss cantonal, federal and international agencies on specific issues relating to our research and development efforts
Key areas in Quality Assurance
- Implementation of quality processes to ensure that the requirements of all technical activities and products (hardware and software) developed at the Wyss Center are fulfilled, hence preventing errors and assuring that the products are suitable for their intended use
- Management of the quality of raw materials, components and subsystems, assemblies and systems that are developed in-house at the Wyss Center or sourced from collaborators and external vendors
Key areas in Clinical Research Management
- Guidance and essential knowledge in all issues relating to human subject research, including ethical considerations of performing research involving human participants
- Clinical trial design and planning, development of clinical trial protocols, development of risk-mitigation plans and management of trial applications to ethics committees and regulatory authorities
- Management of trial implementation and monitoring, as well as drafting clinical evaluation reports
- Coordination of data collection and data protection
- Compliance with clinical research regulations and Good Clinical Practices (GCP)