We offer custom courses for Regulatory Affairs for single individuals or company groups.

Our standard Canadian Fundamentals of Regulatory Affairs course is an excellent offering for companies or individuals entering the Regulatory arena or refreshing their knowledge.  Fundamentals of Regulatory Affairs is offered as a 1 or 2 day course, with your choice of up to 4 units per course day.   

Units offered are

Regulatory Affairs

  • 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)
  • DIN Submissions
  • Changes Post NOC
  • Natural Health Products
  • Advertising
  • Recalls
  • Pharmacovigilance (Regulations, Guidelines, Inspections)

Quality Modules

  • Drug Substance
  • Drug Product
  • Appendices and Regional Information - Canada
  • Overview of ICH Quality Guidelines
  • Post-Marketing changes in Quality Data
  • Writing the Quality Overall Summary and Preparing Module 3
  • Pre-approval Inspections for Biologics
  • Overview of the Review and Approval Process for Marketing Applications for QA Personnel

Compliance

  • GMP for Clinical Sites and Sponsors
  • Regulatory Inspection Management
  • Corrective and Preventive Action for Clinical Sites
  • Clinical Trial Regulations and Guidance Documents

To find out more about how our team at TPIreg can help you, please call us at 905-690-4343 or email us at .

Therapeutic Products Inc. (TPIreg) – a boutique Canadian consulting firm offering regulatory and quality assurance services to the pharmaceutical and healthcare industry in North America.