Adverse Event Reporting and Drug Safety Professional Certification Program (AV01)
||Duration: 7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 7
Accreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 8
Demonstration: Demo an online course.
Certificate: View sample certificate.
PRICE: USD $695.00
Description: This program provides a comprehensive overview of the concepts and requirements necessary for understanding pharmacovigilance, adverse event reporting, and overall drug safety.
Training Provided By: BioPharma Institute
The Adverse Event Reporting and Drug Safety Professional Certification Program Includes the Following Individual Courses:
||Introduction to Drug Safety and Pharmacovigilance:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.
Drug safety monitoring and risk management are vitally important for medicinal product developers, license holders, and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety (or pharmacovigilance). It is important that all staff are aware of the basic requirements. This course will provide those enrolled with an overview of the most important aspects of this discipline, both before and after marketing of products. The course details how these apply most specifically in Europe and the USA.
||Signal Detection and Management in Pharmacovigilance: Product licence holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimization action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources.
The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through ‘data mining’ of large databases, observational studies of ‘real world’ prescription and use, to interventional clinical trials.
This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritization, and risk assessment and minimization.
||Risk Management Planning for Medicinal Products: Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.
||Urgent Safety Restrictions: An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorization for a medicinal product in Europe. This module describes the principles and procedures for USRs.
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