Events

Dec
1

Good Pharmacovigilance Practices (GVP) Inspections 101 (Webinar)

What is trending in good pharmacovigilance practices inspections?
What does Health Canada expect from pharmaceutical companies when conducting GVP inspections?
You will get “the inside” answers to these questions and more when Health Canada’s Sophie Lafrance presents “Good GVP Inspections 101”.

This 120-minute webinar, moderated by CHP Canada’s Kristin Willemsen, will give pharmaceutical firms operating in Canada practical information and insight to help comply with Health Canada’s pharmacovigilance requirements. The webinar will get straight to the point with an emphasis on areas of most cited deficiencies.

Learning Objectives:

After the webinar you will be better able to:
• Describe how Health Canada schedules and conducts GVP inspections.
• Identify Health Canada’s expectations for pharmacovigilance systems which will be assessed during GVP inspections.
• Recognize the recent trends in good pharmacovigilance practices (GVP) inspections.
• Understand how Health Canada attributes risk classification to GVP inspection observations.

Who Should Attend:

• Pharmacovigilance professionals
• Product Quality / Quality Assurance professionals
• Medical professionals
• Professionals involved in managing safety and quality information reporting
• Professionals involved in planning and executing recalls
• Regulatory Affairs professionals

Overview:

As part of Health Canada’s mandate to maximize the safety and efficacy of drugs, the inspection program for Good Pharmacovigilance Practices (GVP) was launched on August 1, 2004. This inspection program assesses compliance of manufacturers with Part C, Divisions 1 and 8 of the Food and Drug Regulations, more specifically sections C.01.016 to C.01.020, C.08.007 and C.08.008.

The GVP inspection program applies to Market Authorization Holders (MAHs) and importers of the following drugs marketed in Canada for human use:
• Pharmaceuticals
• Biologics, including biotechnology products, vaccines and fractionated blood products
• Radiopharmaceuticals

To ensure the uniform application of these requirements and to help industry to comply, the following documents developed by Health Canada will be presented during this webinar:
Good Pharmacovigilance Practice (GVP) Guidelines (GUI-0102)
Risk Classification of GVP Observations (GUI-0063)
Inspection Strategy for GVP for drugs (POL-0041)

About the Speaker:


Sophie Lafrance

Corporate Regulatory Compliance & Enforcement Advisor
Health Product Compliance Directorate, Regulatory Operations and Regions Branch

Health Canada

Biography:
Sophie Lafrance has worked in federal regulations since 2005 when she joined Health Canada’s Health Products and Food Branch Inspectorate (now known as the Health Product Compliance Directorate, RORB). She has been the national coordinator of the Good Pharmacovigilance Practices (GVP) inspection program since 2008. Her role is to support the delivery of Canada’s national GVP inspection program by providing support to inspectors for their inspections, assisting in resolving emerging issues arising from these inspections, liaising with the Marketed Health Products Directorate (MHPD), and contributing to the development of program regulations, policies, and guidelines. Sophie also leads the national GVP Inspection Working Group and the GVP inspection program review. 

Date

December 1, 2017
10:00 a.m. to 12:00 p.m.

Tickets

Members: Free

Non-members: $50.00

You must Log In to purchase this item.

Location

webinar

Tickets

Members: Free

Non-members: $50.00

You must Log In to purchase this item.