Speaker: Dr. Julianne Bobela
This training is organized into 1 module of 3 hours. The objective of this module is to provide ISO 14155 GCP training participants with an understanding of the additional good study practice requirements when planning and conducting a clinical performance study on IVD medical devices within the framework of ISO 20916:2019. The training is aimed at any employee involved in clinical activities on IVD medical devices, who seek to enhance their knowledge and competences within this field.
ISO 20916 defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
The standard is established to ensure the conduct of the clinical performance study will lead to reliable and robust study results, to define the responsibilities of the sponsor and principal investigator, to assist sponsors, CRO, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices and to protect the rights, safety, and well-being of the subjects providing specimens for use in the clinical performance studies.
By attending this training, you will receive in-depth knowledge on the following topics:
- IVDs – Clinical Evidence and Performance Evaluation
- EU Regulatory Framework for Clinical Performance Studies
- US Regulatory Framework for Clinical Performance Studies
- Clinical Performance Study Planning – Study design
- Introduction to ISO 20916:2019:
- Link to Risk Management
- Informed Consent procedure and Data Protection requirements
- Study site selection considerations
- Clinical Performance Study Protocol (CPSP) and other relevant study documents
- Clinical Performance Study submission and authorization procedures
- Roles and responsibilities of clinical investigations’ stakeholders
- Study monitoring activities
- Safety reporting, including adverse event categorization
- End of study requirements and study close-out
Exercises are planned throughout the course. At the end of the training, you will fill out a quiz on knowledge gained and will receive a training certificate.
To attend the course, you are expected to have attended the ISO 14155 training sessions, as this specific training will not detail the aspects already covered by ISO 14155.
EUR 355 incl. course material and certificate