Full course description
If you are an Investigator, Research Nurse or have a research role and you are planning to conduct, or are actively engaged in conducting, a clinical investigation of investigational medical device, then this course is for you.
• Medical Device Definitions and Classification
• CE Mark, Notified Bodies
• EU Device legislation
• Planning and Conduct of Device Investigations
• Documentation required for Clinical Investigations
• PI Responsibilities
• Safety reporting and Quality for medical device investigations
Course is approximately 4 hours duration, undertaken at the participants own pace.
Participants must attain 70% in an MCQ and will get a certificate of attendance on completion.
Participants have 42 days to complete the course online and obtain their certificate of attendance from online registration and payment for same. In the event that the course cannot be completed in this timeframe, participants will need to reregister to maintain access - there will be a €10 administrative fee for same.
The course is given by Dr. Ruben E. Keane, Quality and Regulatory Affairs Director of the HRB-Clinical Research Facility, Cork.
Ruben has 20 years’ experience of Clinical Research (medicines, devices, care pathways etc) in a variety of settings including Pharmaceutical Contract Research Organisations (ICON and Quintiles, Dublin) and Academic settings (Trinity College Dublin and University College Cork).
Ruben’s qualifications include BSc., Ph.D., H. Dip. Appl. Psych (from UCC) and Masters in Pharmaceutical Medicine (TCD).
Ruben has extensive experience in Quality, Regulatory and Pharmacovigilance for Clinical Trials gained during her roles as Clinical Research Associate (Marion Merrell Dow, France and ICON Dublin), Associate Director of Drug Safety (Quintiles Dublin), Project Manager (Trinity College Dublin), and her current role in HRB-CRF Cork.
She regularly delivers courses relating to Clinical Research including ICH-GCP, Introduction to Clinical Research, and GCP for Medical Devices (ISO14155) both within UCC and as guest lecturer.
Student Rate of €40 available, please use code MEEE7F and your institutuional student email address during enrolment to avail of this. Please note that you will be asked to verify your student status following registration using this code (a current, valid, student ID will be requested).
Contacts and Queries:
Payment, registration or certification queries: Centre for CPD Email: firstname.lastname@example.org