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, and capabilities of pharmacovigilance
- 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:
Glenda Guest, C.C.R.A., RQAP-GCP
Lee Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP
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Day 1: 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 2: 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: FDA 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.
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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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-14-001-L01-P. Released 2/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.