|Credits: 1.5 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Drug Safety.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $189.00
Training Program: Drug Safety: Signal Detection and Management in Pharmacovigilance
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.
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 course 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.
This online course supplies the student with a guide that will help them understand signal detection and the proper management of approved products. The process for this subject matter is presented in four stages: minimization and risk assessment; prioritization and signal analysis; signal validation; and signal detection. Interventional clinical trials, observational studies of prescription, and their use in the real world, data mining through large databases, and traditional medical assessment of individual spontaneous reports of adverse events, are some of the methods used.
Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The BioPharma Institute has, for two decades, offered effective, efficient, and convenient training solutions to individuals working in the healthcare, clinical research, and pharmaceutical industries. Contact us to learn more about what the BioPharma Institute can do for you and/or your company.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The Drug Safety: Signal Detection and Management in Pharmacovigilance course is found in the following professional certification program(s):
Module overview – This session provides an outline of the course’s scope and objectives, and notes on terminology. It also defines safety signal and explains our approach to the signal detection and management process.
Signal detection – The question addressed in this session is: ‘Are there data that may indicate a safety signal?’. The various sources of safety signal-relevant data are set out. ‘Traditional’ signal detection by qualitative review of individual case reports is described, followed by a discussion of quantitative analysis of aggregate data on drug-event associations to detect signals of disproportionate reporting, a process known as ‘data mining’.
Signal validation – The question addressed in this session is: ‘Is there a safety signal?’. Steps taken to determine our degree of confidence in the existence of a signal are described. The development of a case series is outlined, and qualitative clues to causality are listed. Approaches to estimation of the incidence of the adverse event(s) in the exposed population are described: including crude approximation of reporting rate, and active surveillance through cohort/prescription-event monitoring and observational study in registries.
Signal analysis and prioritization – The question addressed in this session is: ‘How important is the signal, and do we know enough about it?’. Factors that increase the priority assigned to a signal are listed. The consequences of assignment of a category of risk are outlined. Further investigation of a signal through controlled research, in the form of pharmacoepidemiological studies or clinical trials, is described, and factors influencing a decision to undertake such an investigation are set out.
Risk assessment and minimization – The question addressed in this session is: ‘How does the signal affect benefit/risk balance, and what do we need to do about it?’. Factors affecting re-assessment of the benefit/risk profile of a product in the light of verification of a previously unexpected reaction are set out. Possible risk minimization actions are listed. Requirements for reporting to regulatory authorities are described, and advice is given on communicating safety information to healthcare professionals and consumers.
Assessment – Multiple-choice mastery assessment.
Who will benefit from this module?
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