Inspections and Compliance: A Health Canada Perspective
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See event flyer here
Shila Rastegar, MSc
- 5:30 – 6:00 pm – Registration
- 6:00 – 7:00 pm – Dinner & Networking
- 7:00 – 8:15 pm – Presentations
- 8:15 – 9:00 pm – Networking 1:1 with speaker
Program Description: In Canada, clinical trials of drugs are regulated by Health Canada under the Food and Drugs Act and Part C, Division 5 of the Food and Drug Regulations:
“Drugs for Clinical Trials Involving Human Subjects”.
These laws allow Health Canada to regulate the sale and importation of drugs used in clinical trials, and to enforce good clinical practices (GCP).
To support this framework, in 2002 Health Canada’s Clinical Trial Compliance (CTC) Program was established to verify that clinical trials conducted in Canada comply with the regulations.
The main goal of these inspections is to protect the rights, safety and well-being of
the human subjects enrolled in clinical trials.
Inspections are also conducted to verify the integrity of data collected in clinical trials, and to ensure the generally accepted principles of GCP are met.
With the ever changing drug products landscape and a constant need to adapt to current trends in drug development, Health Canada has started a review of its CTC Program in 2016,
including expanding the scope of the inspection program to get broader coverage of phases of trials and players (Sponsors, CROs, bioequivalence, etc.).
Upon completion of this Seminar, attendees should be able to:
- Understand Health Canada’s organizational changes, roles and
- Discover updates regarding Clinical Trial Inspections and Statistics
- Learn about recent compliance issues
Target Audience: : Industry sponsors, Academic and contract research organizations, Investigators, Senior leadership, REB members, Quality & Compliance, Project managers, CRC’s, CRA’s, Health Care Providers.
- $75 Chapter Members
- $99 ACRP Members
- $125 Non-Members
Contact hours: 1.0 Contact hours have been approved through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members