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This course will help you develop a broader understanding of the new standard, ethical considerations and how to conduct a clinical trial from start to finish. You will also discover the new responsibilities of sponsor/CRO and principle investigator, and learn about safety and adverse events under the new standard. -
This lecture describes the key changes in the international ISO standard for clinical trials. In this module we will show you the main changes that have occurred compared to the ISO 14155 2011 in the safety and adverse event reporting. -
This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities. -
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities. -
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout. -
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for Ethics and the informed consent process. -
MDR is finally here and takes effect in May 2020! This video lecture provides you with an overview of the new regulations and clinical responsibilities set forth by the new ISO 14155 2020. -
This webinar provides an overview of the innovations in clinical trials and provides practical suggestions on how to get ready now – as the standard is already effective and everyone is expected to comply! -
LEARN FOR FREE This recorded video-lecture by Dr. Monica Tocchi, who contributed to the development of international standard ISO 14155 for clinical trials. This introductory course describes the key changes that affect pre-market studies and post-market trials for medical devices.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
