Essential Regulatory Documentation in Clinical Research with Medical Devices
Duration : 90 Minutes
Marina Malikova, Executive Director, Boston University School of Medic
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics an Read more
Both ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Course Objectives:
Course covers the regulatory requirements for medical devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided is an in-depth review of relevant FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a device products from clinical research point to the market.
Content and preparation of regulatory submissions, including an Investigational Device Exemption (IDE), and a 510K PreMarket Notification will be described.
Course Outline:
• Define clinical research essential documentation for clinical trials with medical devices
• Review the ICH GCP requirements for essential documents for medical devices
• Describe the significance of document management in clinical research with medical devices
• Learn how to set up, maintain and manage a document system that meets regulatory standards
• Understand the role of auditors, and learn how to archive documentation and prepare for a quality assurance (QA) audit or regulatory inspection.
• Prepare for regulatory inspection: Proactive and reactive use of essential documentation
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory affairs professionals
• Medical Affairs
• Project managers
• Clinical Research Associates (CRAs) involved in planning, monitoring, execution of trials and responsible for clinical trial reporting
• Grant managers
• Principal Investigators
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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