The Emerging PV Landscape in CanadaDay & Time:
October 28, 1:30PM - 5:00PMDescription:
This tutorial will focus on four emerging areas of change in pharmacovigilance (PV) and present them within a Canadian context. The first area deals with the new good pharmacovigilance practice (GVP) Inspection guidelines and policy that have been released by Health Canada and become effective September, 2013. Areas of change from previous inspection model will be highlighted.
The second area in this tutorial will focus on the recently announced acceptability of Periodic Benefit Risk Evaluation Reports (PBRERs) to meet the requirements for Canadian Summary reports in Canada. Focus will be on how these reports differ from PSURs and how to begin to develop these new format reports for Canadian submission.
The third emerging area of change that will be reviewed is the development of the PV Master File, a new concept recently introduced by Europe, and the associated PV Quality System. We will review how to set up a PV Master File in Canadian context and how to set up a robust PV Quality System. Discussion will focus on implementing the Master file concept and maintaining it over time. We will discuss the benefits of moving in this direction for Canada only and within the context of a global PV environment.
The fourth area will overview the Risk Management Plans (RMPs) in Canada, their current status and general considerations when submitting them, background on Drug Utilization Research and describe Health Canada expectations when designing them, and applied overview of some common Health Canada Risk Management Plan review comments will be provided.
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At the conclusion of this tutorial, participants should be able to:
- Explain the changes in the new GVP Inspection process and expectations, including feedback from industry and Health Canada in terms of recent observations and risk classifications.
- Describe the new PBRER (Periodic Benefit Risk Evaluation Report) that will replace the PSUR (Periodic Safety Update Report) and how these meet or do not meet Canadian requirements for an Annual Summary Report.
- Discuss the Pharmacovigilance Master File, how Canadian branch offices participate in this file, how such a file may be of use to your organization and how to go about building such a file if you determine that is the way forward for you.
- Discuss the status, design and expectations regarding Risk Management Plans in Canada
Pharmacovigilance, Medical Information and Regulatory staff interested in meeting the new PV challenges developing globally. QA, Medical and Clinical Research staff will also find this of interest as there are areas that touch on these discipline areas. Those in Project Management, General Management and Marketing can get a good understanding of the changes ongoing within the PV environment and how they will impact your company.