This course provides an excellent introduction for newcomers to the field of drug and biologic product AE reporting, a comprehensive overview of current approaches and regulations for professionals in the field, and challenging questions and ideas for the experienced clinical research professional. This course contains medical device content related only to use in combination products.
- Explain the purpose and capability of adverse event reporting
- Review and apply the concepts of seriousness, expectedness, and causality
- Review how to describe, characterize, and document adverse events
- Discuss safety issues and reporting obligations associated with clinical trials and marketed products including combination products
- Identify key concepts related to electronic records
- Discuss the use of various coding systems
- Describe the evolving role of the FDA in drug and biologics development
- Clinical Trial Personnel responsible for collecting, reviewing, and reporting investigational adverse events.
- Safety Surveillance Personnel responsible for the acquisition, classification, entry, analysis, and reporting of adverse events in marketed products.
- Regulatory Affairs Personnel responsible for submitting safety reports to FDA and international regulatory authorities.
- Quality Control Personnel involved in the investigation of adverse event reports
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to AE Management and Reporting: Brief history of the FDA; pertinent historical/ethical perspectives; overview of pharmacovigilance
- Clinical Trials: Overview of Regulations: FDA, ICH, EU, ISO; of concepts: causality, relatedness/expectedness, serious; sponsor reporting variations; FDA and international expedited reporting; post-marketing clinical trial considerations; reporting into IND; reporting into NDA; review of warning letters
- Use of Electronic Records and Coding Concepts: Electronic records: regulations, considerations in your environment, storage, submissions; MedDRA; SNOMED
Day 2: 8:30 a.m. – 5:00 p.m.
- Post-Marketing: Overview of FDA and international regulations; FDA and international reporting requirements; labeling requirements; product complaints/quality control; review
- Combination Products: Introduction to device regulations, definitions, concepts; overview of Office of Combination Products; reporting considerations for combination products
- Routine Reporting in Clinical Trials
- Using MedWatch for 15-day Alerts
- Practice Using Coding Terminology
- Analysis of AE Reports on Combination Products
- Review of FDA Warning Letters
- Review and Evaluation of FDA Warning Letters in the Post-Marketing Setting
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# 0778-0000-16-029-L01-P. Released 10/16.
This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Approval Number: 7662-2/16-18. 14 Hours
Participants will receive 14 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.