Medical Device Clinical Trial CoursesCITI - Collaborative Institutional Training Initiative. The GCP series includes three distinct basic courses tailored to the different types of clinical research, along with three corresponding refresher courses that are intended to provide learners with a highlighted review of what is covered in the basic modules. The available GCP courses include. GCP for Clinical Trials with Investigational Drugs and Medical Devices (U. S. FDA Focus)*. GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)*. GCP for Clinical Investigations of Devices. GCP FDA Refresher*. Clinical Trials: Medical Device and Drug. Course Schedule Life Sciences. Introduction to Clinical Research with Medical Devices.
GCP ICH Refresher*. GCP Device Refresher* Trans. Celerate Mutually Recognized GCP Training. For the GCP Courses marked above, ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Trans. Celerate Bio. Pharma as necessary to enable mutual recognition of GCP training among trial sponsors. Available translations that meet Trans. Celerate minimum criteria include: Spanish. Curso de Buenas Pr. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U. S. FDA- centric curriculum. GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH- focused curriculum. GCP for Clinical Investigations of Devices and GCP Device Refresher are most appropriate for organizations or individuals who desire a more international- focused GCP curriculum and a more device- focused program. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 1. Independent Learner registration is available for $1. Clinical Trial Design For Medical Devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use. This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered. Who Should Attend. This two day course is designed for Medical Device professionals involved in clinical trials. It is primarily designed to benefit the following disciplines and personnel: Clinical Affairs. Medical Directors. Regulatory Affairs. Product Development. Project Managers. Course Agenda. First Day. Introduction to Clinical Trials. What is a clinical trial? Why are clinical trials performed? Types of clinical trials. Differences between medical device, drug, and biologic trials. Premarket vs. Post Market Clinical Trials. What is a premarket clinical trial? Types of premarket clinical trials. Pilot (feasibility)Pivotal. What is a post market clinical trial? Types of post market clinical trials. Condition of Approval. Registry. Post Market Surveillance/5. How Claims for Medical Use Impact Trial Design. Intended Use. Indications for Use. Implied Claims. Comparative Claims. Protection of Human Subjects. Declaration of Helsinki. Informed Consent. Ethical considerations. Institutional Review Boards (IRB)/Ethics Committees (EC)Purpose. Organization. Responsibilities. Records and reports. US and EU Premarket Regulatory Requirements.
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