Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and r (Clinical)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Oct 29, 2010 End Date/Time: Oct 29, 2010
Report as Spam


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


Online Event
2600 E. Bayshore Road
Palo Alto
United States