Date: 13 October 2023
Time: 9:00 – 17:00 CEST
Price: € 699,-
Location: Novotel Amsterdam Schiphol Airport | Amsterdam, the Netherlands
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials that involve the participation of human subjects. The ISO 14155:2020 standard addresses GCP for medical device studies. Studies in Europe must comply with the standard, and the standard is also recognized by the US FDA and many other regulatory authorities around the globe. This training provides an introduction into the ISO 14155 standard and GCP principles for medical device studies.
PMCF user surveys are questionnaires to end-users of a medical device that are designed to collect clinical data. To be able to use those data to support that you have sufficient clinical data under the Medical Device Regulation (MDR), a high-quality survey is required. Such a survey is patient-specific and well-designed, with clearly stated endpoints, a statistical analysis plan and an appropriate rationale for the design, among other requirements. In this training, we will examine in detail how a survey can be designed, conducted, and reported, including the definition of endpoints and statistical considerations. The use of PMCF user survey data for other geographies than Europe will also be discussed.
Qserve CRO experts: Bianca Lutters, PhD and Armêl Plaine, PhDRegister now