This course provides information across the full range of medical device clinical trial activities. It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.
- Navigate the regulatory pathways for medical devices in the U.S
- Explore practical aspects of investigator and monitor selection
- Comply with the fundamentals of Good Clinical Practice (GCP)
- Explore practical aspects of conducting international clinical trials
- Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
- Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials
- Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process
- Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process
Albert A. Ghignone, M.S., R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to the FDA: History; law; definitions
- Medical Device Process: Three classes of device; 510(K); IDE; PMA
- Clinical Research Process: Types of clinical studies; clinical study controls; international studies; ICH process; guideline process
Day 2: 8:30 a.m. – 5:00 p.m.
- ICH GCP: Sponsor obligations; investigator obligations; IRB/IEC obligations
- Monitoring: Five basic monitoring visits
- Adverse Device Experience: Expected; unexpected
- Data Management: Data entry; data query; validation
- FDA Bioresearch Monitoring Program: Site audits
- Clinical and Data Management Discussions
- Review of Regulatory Documents
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-13-036-L01-P. Released: 12/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.