DDReg Pharma

Pharmacovigilance Services in Canada

In Canada, it is mandatory to have a pharmacovigilance system to assure continuous monitoring of medicinal products and medical devices for their safe use. The Canada Vigilance Program is Health Canada’s pharmacovigilance program that is accountable for collecting and assessing the adverse drug reaction reports of health products. Anyone including health care professionals, patients/consumers, manufacturers, and distributors can submit the adverse drug reaction (ADR) reports directly to Health Canada or to Marketing Authorization holders. There are seven regional offices of Canada Vigilance which act as regional points of contact for the health professionals and support The Canada Vigilance Program to collect reports from these regions which are further forwarded to the Canada Vigilance National Office for further analysis. In addition to this Canada maintains Canada Vigilance Online Database for all the suspected adverse drug reaction reports.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end to end pharmacovigilance services in Canada that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg Pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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