Recorded Webinar – Pharmacovigilance Regulations and Good Pharmacovigilance Practices

Overview

Drug Safety has significantly evolved in the last 2 decades. Regulatory Authorities including Health Canada have focused on Good Pharmacovigilance Practices (GVP) pertaining to the Pharmaceutical Industry. There is also an emphasis on benefit-risk evaluation, and risk management rather than passive drug safety surveillance alone. Regulatory compliance including requirements for Annual Safety updates (PSUR/PBRER), may also include a necessity for a Pharmacovigilance (PV) plan, and Risk Management Plan (RMP), based on the benefit-risk profile of a drug. Recent changes in the Canadian Food and Drug Act (Bill C-17) have provided Health Canada with significantly more authority to protect Canadians from unsafe drugs, which include strengthen oversight of pharmaceuticals and medical devices, and authority to act on safety issues (including post-marketing requirements, labelling modification, product recall, stop-sales, or other corrective action) including non-compliance (with significant fines).

Health Canada implemented an inspection program for Good Pharmacovigilance Practices (GVP) in 2004. The program is intended to verify that Market Authorization Holders (MAH) and importers, meet the requirements of sections C.01.016 to C.01.020, C.08.007 (h) and C.08.008 (c) of the Food and Drug Regulations.

Guidance documents released by Health Canada help to ensure uniform application of these requirements by the industry and include: 1) Good Pharmacovigilance Practice (GVP) Guidelines (GUI-0102) (which outlines the interpretations of the regulations with respect to the adverse drug reaction and post-approval reporting requirements), 2) the revised Risk Classification of GVP Observations (GUI-0063), and 3) the Inspection Strategy for GVP for Drugs (POL-0041).

The European Medicines Agency is the medicines regulatory authorities in EU Member States. They cover medicines authorized centrally via the Agency as well as medicines authorized at national level. The European Medicines Agency (EMA) have provided a comprehensive document on GVP as a set of measures to facilitate the performance of pharmacovigilance in the European Union (EU). It is the best benchmark for GVP internationally. It contains 16 modules covering major pharmacovigilance processes.

Abstract

This course, will be cover the Health Canada regulations for Drug Safety and related guidance documents, along with selected EMA GVP documents. Participants will obtain a core understanding of compliance requirements for Good Pharmacovigilance Practices.

A one-day comprehensive & interactive seminar, covering the following items:

• Sections of the Health Canada Food and Drug Act pertaining to Drug Safety activities
• New Regulations introduced in Canada (Bill C-17)
• Health Canada Guidelines GUI-0102, GUI-0063, and POL-0041
• Selected EMA GVP documents including:
• Pharmacovigilance systems and their quality systems
• Pharmacovigilance system master file
• Pharmacovigilance inspections
• Pharmacovigilance audits
• Risk Management systems
• Management and reporting of adverse reactions to medicinal products
• Periodic safety update report
• Post-authorizations safety studies

Who should attend:

• Drug Safety Associates and Managers
• Clinical Research Associates and Managers involved in Phase IV studies
• Contract Research Organizations with a drug safety role
• Personnel involved in Medical Information Services
• Company personnel initiating a Drug Safety team or having concerns regarding ADR

The course is designed for those who work in Quality, Regulatory Affairs, Clinical Research, etc. and wish to gain a more in depth knowledge of pharmaceutical formulation and manufacturing.