Pharmacovigilance course was designed to help personnel in the pharmaceutical industry to monitor the effects of licensed pharmaceuticals and medical devices to identify and assess adverse reactions and adverse events. Since medicines are licensed based on benefits and risks assessments, continued assessment of risk is necessary after a drug is licensed. This pharmacovigilance course will focus on the collection and detection of adverse effects. It will also include how adverse reactions are assessed, monitored and prevented in order to ensure the safety of the patients. Pharmacovigilance is required in Canada for all drugs.
This pharmacovigilance course provides in-depth knowledge and skills for those already working in the field of pharmacovigilance. It will also help those who are looking for an entry position in pharmacovigilance and do not want to take a full Regulatory Affairs program. It addresses the pharmacovigilance requirements for the Canadian, USA and the EU markets.
General information for pharmacovigilance course
In this pharmacovigilance course you will gain deeper understanding of pharmacovigilance (Pv). It is designed for personnel who deal with patient safety issues during pre-market drug development all the way until it’s licensed as well as throughout its life cycle. There are several similar online courses but either they completely ignore the Canadian Market or are too brief. This course includes the Canadian market as well as other jurisdictions. The course will be relevant to:
Regulatory affairs Professionals,
Clinical safety staff
Quality Management personel
Pharmacovigilance Associates And Managers
Clinical Research auditors
Clinical Investigators and Managers of Clinical trial
Learning Level: Basic and intermediate
Total Length of Course: 35 hours
This pharmacovigilance course is for pharmaceutical personnel who want to have a better understanding of the collection, detection ,assessment and prevention of adverse effects. A good command of English language and a understanding of biology and medical terminologies are recommended.
The following will be covered in this course.
General overview of pharmacovigilance
Global Regulatory Pharmacovigilance requirements
Signals and Risk Assessment
Medical Device vigilance
Good Clinical Practice
Students will be able to do the following and more after completing this course
Describe pre-market and post-market adverse events
Describe the adverse event process flow
Understand how to assess adverse events reports
Describe the differences in Eu, USA and Canadian legislation for reporting and assessing of adverse drug reactions and adverse events
Discuss the main considerations in pharmacovigilance audits and inspections
Understand how to compile pharmacovigilance checklist
Describe the legalities of signal detection and analysis in USA, Canada and Eu.
Know how medical devices safety and vigilance data are collected, assessed and transmitted to Regulatory Agencies
Discuss trend analysis and risk management of medical devices
Pharmacovigilance course is delivered through our secure student friendly online Learning Management System.
pharmacovigilance course. There are 4 modules. Each module has 4 topics. Students will have one quiz per module. Each module will also have one assignment.
Click here for a sample Quiz and a screenshot of one of the modules