Adverse Drug Events – Understanding & Reporting Requirements
November 10 - 11, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues. Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered. Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.