This
course provides a detailed and thorough introduction of FDA regulations for
newcomers in the field of medical device safety: a comprehensive overview of
the requirements, current approaches for professionals in the research and
post-marketing areas, an overview of the emerging field of devices that deliver
drugs or biologics, and an opportunity to discuss the challenges facing those
reporting and managing adverse events in the medical device industry.
- Discuss the history of, need for, purpose of adverse event reporting in medical devices (device/safety vigilance)
- Define the terms related to
reporting adverse events in clinical trials: seriousness, expectedness,
and causality
- Describe current considerations in
reporting adverse events in clinical trials: timing, terminology, consent,
blinding, device-related versus procedural complication, and follow-up
- Describe the reporting requirements
for adverse events observed in clinical trials involving devices
- Evaluate and express the safety
issues and information sources for marketed products
- Explain the rationale underlying the
reporting requirements of adverse events in marketed products
- Discuss why and how coding
terminologies (including MedDRA) are used
- Summarize the considerations
required when the device delivers a drug/biologic
- Critique the past and evolving roles
of the FDA in device safety
- Clinical Trial Personnel (Monitors, Managers,
Support staff, Data Entry) responsible for: 1) collecting, reviewing, and
reporting adverse events occurring in clinical trials of new and marketed
products; and 2) ensuring adverse event reporting compliance at the
investigator site
- Quality Control Personnel involved
in the investigation of adverse event reports
- Regulatory Affairs Personnel
responsible for submitting safety reports to FDA and other health
authorities
- Safety Surveillance Personnel
responsible for the acquisition, classification, entry, analysis, and
reporting of clinical trial and marketed products adverse events
- Medical Affairs Personnel
responsible for safety-related decisions regarding product labeling,
regulatory interactions, or customer communication.
The course will be led by one of the following
instructors:
Lee
Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP
Glenda Guest, RQAP-GCP,
C.C.R.A.
Click here for complete trainer biographies
Day One: 8:30 a.m. – 5:00 p.m.
- Overview of Safety: History; need for safety surveillance and what
it can accomplish; FDA regulations; Good Clinical Practices; CIOMS recommendations;
ICH considerations
- Adverse Event Reporting in Clinical Trials: Review of FDA regulations, definitions, and concepts;
Good Clinical Practices; IDE safety reporting
- Coding: Narrative descriptions; electronic records; coding
principles, standardized dictionaries: COSTART, WHO-ART, and MedDRA
Day
Two: 8:30 a.m. – 5:00 p.m.
- Adverse Event Reporting for Marketed Products: Managing domestic spontaneous reports: maximizing information,
minimum requirements for a valid report; managing events from other
sources: foreign, literature, and FDA; reporting requirements to the FDA and
other authorities
- Considerations When a Device Delivers a Drug/Biologic: Overview of drug/biologic adverse event definitions and
concepts; overview of reporting requirements in clinical trials and
post-marketing
- FDA’s Role in Device Safety: audit procedures; post-inspection reports and findings
- Adverse Event Reporting in Clinical Trials
- Analyzing the Key Concepts:
Expectedness, Labeling, and Seriousness
- Case Studies
- Review and Evaluation of FDA Warning
Letters
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.
Click here for our seminar
cancellation policy
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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-17-001-L01-P.
Released: 2/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.