World Conference Calendar

35127 Conferences

Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-10-29
Last Date Last Day: 2010-10-29

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This adverse event reporting Webinar/training will discuss the clinical trial regulations requirements with respect to adverse event and explain how to assess and report AEs and SAEs.

Areas Covered in the seminar:

The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more.
How to know what an Adverse Event is and when to report it or them.
Understanding laboratory AEs and the "Reference Range" concept.
Type A and Type B Adverse Reactions.
Common Mistakes in AE / SAE Reporting.
Reporting of Adverse Events - when and to whom and the use of Adverse Event.
Terminology systems.
The Role of Data safety Monitoring in Protecting Human Volunteers.
How to record Adverse Events and assess causality - the algorithm.

Who will benefit:

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
Principal Investigators / Sub-investigators.
Clinical Research Scientists (PKs, Biostatisticians).
Safety Nurses.
Clinical Research Associates (CRAs) and Coordinators (CRCs).
QA / QC auditors and staff.
Clinical Research Data managers
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