Obtain Practical Knowledge
Spharm provides training services to individuals and organizations to enable a practical understanding of the drug regulatory approval processes.
Our course materials are developed in-house and are constantly updated to keep current with industry practices and changing regulatory environments.
The training we provide includes real-life examples with case studies and hands-on exercises to illustrate concepts and deepen your knowledge.
We offer both custom and standard training sessions. Learn more about some of the modules we cover in our training.
Drug Regulations in Canada and Overview of Health Canada
The Common Technical Document
Clinical Trial Regulations
New Drug Submissions (Standard, Priority, NOC/C, Exclusivity)
New Drug Submissions (Biologics, Generics, Subsequent Entry Biologics)
New Drug Submissions (Fees, Time for Reviews, Appeals)
Changes Post NOC
Pharmacovigilance (Regulations, Guidelines, Inspections)