Study Initiation Visit in clinical Investigations - what to cover: ISO 14155:2020, Data Protection, and SAE reporting requirements

To meet regulatory compliance within the EU and the United States, medical device manufacturer and CRO need to meet the latest edition of ISO14155 Standard (Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice). Conducting clinical studies according to GCP is mandatory to collect clinical data in ethical conditions. There have been significant changes that introduce clarifications to facilitate compliance with other international clinical trial standards, such as the International Council for Harmonisation Good Clinical Practice (ICH-GCP).

Learning objectives:

ISO 14155:2020 Study Initiation Visit – ISO 14155:2020 Sponsor and Investigator responsibilities, MDR SAE reporting, Data Protection

Join ECLEVAR MEDTECH for this webinar to have an overview and understanding of the ISO 14155 standard , key changes, and explore planning and implementation of clinical investigation are key to commercial success.

Focus points:

Recognition of ISO 14155-2020
Best practice in clinical investigation
Summary of GCP principles (Clause 4)
Registration of the clinical investigation in a publicly accessible database (Clause 5.4)
Risk-based monitoring and considerations when writing the monitoring plan (Clause 6.7)
Clinical quality management (Clause 9.1)

Statistical considerations (Annex A)
Guidance for ethics committees (Annex G)
Risk management throughout the entire process of a clinical investigation (Annex H)
ISO 14155 GCP requirements for different clinical development stages (Annex I)
Guidance on clinical investigation audits (Annex J)

For whom:

All Clinical staff involved in the preparation, execution or evaluation of clinical investigations of medical devices.

Link to subscribe

By registering for this event, you are providing ECLEVAR MEDTECH consent to contact you directly regarding ECLEVAR MEDTECH’s services. The information you are providing will be processed by ECLEVAR MEDTECH to better understand your product needs and interests. For additional information, please visit our Privacy Policy or contact us at DPO@eclevar.com.