This pharmacovigilance training course was designed to meet the needs of those involved in any aspect of pharmacovigilance in Canada and USA. It will help you to comply with Canadian and USA requirements. Like GMP, pharmacovigilance training is required for anyone involved in pharmacovigilance activity. Lack of adequate pharmacovigilance training is a risk to patients. Companies without a proper pharmacovigilance department, unit, or personnel can lose market authorization in Canada.
Its difficult to find a good Pharmacovigilance training course in Canada. The few that are available may not be easily accessible. Courses dealing with the Canadian pharmacovigilance are very few and will probably increase. Pharmacovigilance courses in Canada are few outside of Ontario.
Those who are hoping to find employment in pharmacovigilance will find more regulatory affairs courses than pharmacovigilance. There are few pharmacovigilance courses in Ontario. Training is usually done offline. In a few cases it’s available online
This pharmacovigilance training course is offered both online and offline. Most of the course is done online. To qualify for the offline course, you will need to complete the online course. The offline course is bonus as there is no extra charge if you complete the online course. It’s however optional. The one day offline course is a summary of the online course. It’s also meant to address any question that may not have been answered during the online courses. Registration for this course is deemed to be registration for the online course. Click here to see the course description , the fees and other details.
You will be awarded a certificate if you complete the online course. The certificate will be sent to your address by registered mail. You must provide your correct mailing address during registration.
Who needs pharmacovigilance training?
Those involved in regulatory affairs need this course as they are involved in the life-cycle planning of a drug. Regulatory affairs also need to inform regulatory agencies of changes that may occur due to drug safety concerns. The changes may be related to the safety information submitted during the application for market authorization.
Pharmacovigilance auditors also require this course . These professionals Audit and evaluate the arrangements made to meet the relevant regulatory requirements of pharmacovigilance. They also verify whether the arrangements are properly and consistently implemented. They also look for documented evidence to support observations.
Pharmacovigilance associates, pharmacovigilance specialists, clinical investigators and managers of clinical trials will all need this pharmacovigilance training course.