Take advantage of our $1507.50 price by registering early!
* After Monday, February 4, 2019, costs are $1687.50.
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
- Explain the purpose and capability of AE
- 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
- Discuss the use of various coding
- 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
- Quality Control Personnel involved
in the investigation of adverse event reports
The course will be led by one of the following
Guest, RQAP-GCP, C.C.R.A.
Marla Hoelle, R.N., B.S.N.,
Click here for complete trainer
Day One: 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; 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
Two: 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
- Review of FDA Warning Letters in the
Clinical Trial Setting
- Review and Evaluation of FDA Warning
Letters in the Post-Marketing Setting
- Analysis of AE Reports on
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
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.
this course at your company! For more information, contact Naila Ganatra at +1