Invited Speaker

Challenges and Opportunities in the Safety Surveillance of Drugs used in the Management of Autoimmune Diseases:“The Canadian Perspectives” and Applicability of the Pharmacovigilance Planning at the Drug Developmental Phase
Duc Vu
Canada

Background: Therapies currently used in the treatment of autoimmune diseases carry many significant safety issues that require rigorous and comprehensive approaches in the surveillance of their safety profile. Several biological therapies have emerged in recent years, and while the manufacturing process largely defines the product, there are class properties emerging. Unique safety issues with drugs for autoimmune disorders have also come to light and present challenges in capturing and measuring adverse events in clinical trials and in the broad market-use context.

The Canadian Food and Drugs Act and Regulations provide a fundamental level of regulatory oversight over the life cycle of health products including product development, market authorisation and post-market surveillance activities. At this time, Health Canada is working towards introducing a Progressive Licensing Framework with revisions of the Regulations to implement, consistently, important activities under International Conference of Harmonisation (ICH) guidelines and the use of tools such as risk
management planning, pharmacovigilance planning and submission of periodic safety update reports (PSURs) in our drug review process.

A number of elements could be presented and discussed including patients’ safety through monitoring risks and benefits associated with new and existing therapies.

Furthermore, one or more of the following issues will be presented:

A- Signal detection activities using “Canada Vigilance database”, and “International Adverse Drug Reaction databases” as well as information from PSURs (Periodic Safety Updates); B- Registries in the investigation of various safety signals such as risk of Progressive Multifocal Leukoencephalopathy (PML); opportunistic infections; cancer reported in association with various biological/ therapeutic products used in the treatment of traditional, and emerging autoimmune diseases.

Safety issues with pharmaceutical drugs will be also reviewed with a view to highlighting commonalities and differences with biological therapies.

This proposed session will additionally explore the opportunities and challenges associated with different international regulatory systems in the surveillance of drug safety during active clinical trials (premarket phase), and of approved therapies (post market phase). This study will provide useful information on the pharmacovigilance planning at the developmental phase of those products.