Canada's clinical trial regulations are intricate and complex, with numerous guidelines, standards, and legal requirements governing the conduct of clinical trials nationwide. A recent Health Canada report indicated that over 25% of clinical trials face delays due to non-compliance, as regulatory authorities have intensified their focus on ensuring participant safety and data integrity.
This certified program is designed to help you navigate the complex landscape of Canadian clinical trial regulations and achieve full compliance for your clinical projects. You will gain a comprehensive understanding of the legal framework governing clinical trials in Canada, including the Food and Drugs Act, Good Clinical Practice (GCP) compliance, the Clinical Trial Application (CTA) process, the Medical Devices Regulations, and more. Additionally, you will explore recent changes and updates to these regulations, ensuring your knowledge remains current and relevant.
Participants will delve into essential aspects of clinical trial regulations, such as developing robust clinical trial protocols, implementing effective compliance monitoring systems, accurately interpreting regulatory requirements, and ensuring rigorous safety reporting and data integrity. You will also learn best practices for designing and conducting compliant clinical trials, as well as strategies for effectively communicating with regulatory authorities and research ethics boards. Furthermore, you will gain expertise in pharmacovigilance, learning to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Canadian requirements.
Through a combination of interactive lectures, case studies, and practical exercises, you will explore critical areas such as ethical considerations in clinical trials, patient recruitment strategies, and post-approval surveillance. These skills will enable you to accurately interpret regulations and develop systems for ongoing compliance management.
Upon successful completion of the program, you will be awarded the Certification in Canada Clinical Trial Regulations and Compliance. This distinguished certification not only enhances your professional qualifications but also demonstrates your specialized knowledge in navigating the complexities of the clinical trial regulatory landscape in Canada. Furthermore, this industry-recognized certification holds lifelong validity, serving as a testament to your dedication and expertise in maintaining the highest standards of clinical trial compliance, quality, and patient safety.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Download Brochure Pricing & Registration- Experience 2 days of intensive instructor-led live program and acquire in-depth knowledge and understanding of the complexities of clinical trial regulations, compliance requirements, and participant safety within the Canadian regulatory framework.
- Attain the industry-recognized Certification in Canada Clinical Trial Regulations and Compliance, demonstrating your expertise in navigating the regulatory landscape governing the clinical trial process from preparation and submission to approval, reporting, and compliance measures.
- Gain insights from impactful best practices in managing Clinical Trial Applications (CTAs), adhering to Good Clinical Practice (GCP) guidelines, and ensuring regulatory compliance to enhance participant safety and improve data integrity in your clinical trial projects.
- For inquiries, chat with our Program Advisers at [email protected] or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
According to a survey by the Canadian Clinical Trials Coordinating Centre, 72% of clinical leaders cited significant challenges when conducting clinical trials in Canada due to complex regulatory requirements, overwhelming documentation and stringent approvals.
This certified program will provide you with a thorough overview of the regulatory landscape, covering essential frameworks such as the Food and Drugs Act, Good Clinical Practice (GCP) guidelines, and ICH E6 (R2) standards. Participants will gain valuable insights into the Clinical Trial Application (CTA) process, from initial preparation through submission and approval. You will also gain insights into the intricate requirements for documentation and safety reporting protocols, adverse event reporting protocols as well as the impacts of non-compliance in clinical trials.
Throughout the program, participants will learn to navigate Health Canada's specific clinical trial requirements, comply with Research Ethics Board procedures and implement effective informed consent protocols to ensure the highest ethical standards are maintained. Furthermore, this program will equip you with practical skills to integrate these regulations into clinical trial design and management, ensuring compliance and ethical conduct throughout the trial process. This includes understanding the complexities of multi-provincial trials within Canada and adapting to evolving regulatory requirements. Additionally, you will also gain insights into effective data management and safety reporting techniques along with robust safety management plans that mitigate potential safety concerns.
Upon successful completion, you will receive the Certification in Canada Clinical Trial Regulations and Compliance, demonstrating their proficiency in navigating Canada's clinical research landscape. This industry-recognized certification not only enhances professional credentials but also showcases a commitment to maintaining the highest standards of clinical trial conduct in Canada.
Key Skills You Will Gain
- Clinical Trial Regulatory Framework
- Clinical Trial Application (CTA) Process
- Health Canada's Legislation Framework
- Informed Consent and Ethics Review Expertise
- Good Clinical Practice (GCP) Compliance
- Regulatory Submission Procedures
- Post-Marketing Surveillance
- Regulatory Inspection Management
- Global Regulatory Strategy
- Investigator's Brochure (IB)
- Informed Consent Form (ICF)
- GCP Compliance: ICH E6(R2)
- Standard Operating Procedures (SOPs)
- Adverse Event (AE) Reporting
- Serious Adverse Event (SAE)
- Research Ethics Board (REB) Standards
- Food and Drug Regulations (FDR)
- Quality Assurance (QA)
- Quality Control (QC)
- Corrective and Preventive Action (CAPA)
- Trial Documentation
- Clinical Trial Protocols Development
- Stakeholder Communication
- Clinical Risk Management
- Clinical Data Integrity
- Site Selection and Management
Your Faculty Director
Jordan John is a distinguished leader in regulatory affairs, compliance, and quality management, with over a decade of experience in navigating complex regulatory landscapes. Currently, he serves as the Director of Regulatory Affairs, Compliance & Quality where he oversees compliance with FDA, EU, Health Canada, TGA, PMDA, and other international regulations.
As an Advisory Board Member at Humber College since April 2024, Jordan contributes strategic insights to clinical regulatory and compliance education. He also served as a Professor, developing and lecturing in regulatory affairs and quality assurance programs. His previous roles include Senior Regulatory Affairs at Fio Corporation, where he led IVD/device submissions to Health Canada, FDA, and other jurisdictions, and Regulatory Affairs Specialist and Consultant at Southmedic Inc., where he developed regulatory strategies and led audits and QA projects.
Jordan's comprehensive knowledge and experience make him an invaluable asset in the field of regulatory affairs and compliance, ensuring the highest standards of quality and safety in clinical trials and medical device management.
Canada Clinical Trial Regulations and Compliance Program Agenda
How You Will Benefit
- Master Canadian Clinical Trial Regulations: Gain comprehensive understanding of the Food and Drugs Act, GCP compliance, CTA process, and Medical Devices Regulations.
- Develop Compliant Trial Protocols: Learn to create robust clinical trial protocols that adhere to Canadian regulatory requirements and ethical standards.
- Implement Effective Monitoring Systems: Acquire skills to establish and maintain compliance monitoring systems throughout the clinical trial process.
- Ensure Rigorous Safety Reporting: Master techniques for accurate identification and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Navigate Ethical Considerations: Explore critical areas such as patient recruitment strategies and post-approval surveillance while maintaining ethical integrity.
- Master the CTA Process: Gain expertise in preparing, submitting, and obtaining approval for Clinical Trial Applications.
- Comply with Research Ethics Board Procedures: Learn to effectively interact with and adhere to Research Ethics Board requirements and protocols.
- Implement Informed Consent Protocols: Develop skills to design and execute effective informed consent procedures that meet regulatory standards.
- Manage Multi-Provincial Trials: Understand the complexities of conducting clinical trials across multiple Canadian provinces and adapting to varied requirements.
- Develop Safety Management Plans: Learn to create and implement robust safety management plans that effectively mitigate potential safety concerns in clinical trials.
Certification in Canada Clinical Trial Regulations and Compliance
Upon successfully completing this program, you will be awarded the Certification in Canada Clinical Trial Regulations and Compliance, which can be included in your resume, CV, and other professional credentials. This industry-recognized certification holds lifelong validity.
Globally sought-after and respected, this certification will elevate your professional qualifications and demonstrate your expertise in clinical trial regulations, compliance, and safety protocols within the Canadian regulatory framework. Developed by the Chartered Institute of Professional Certifications, the program content has been independently accredited by the CPD Certification Service, ensuring it adheres to the highest standards of continuing professional development principles.
Pricing & Registration
Canada
Dates: 4 - 5 Feb 2025
Venue: Online Executive Program (via Zoom)
Time: 8:00am - 3:30pm Pacific Standard Time (PST)
10:00am - 5:30pm Central Standard Time (CST)
11:00am - 6:30pm Eastern Standard Time (EST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 02 Dec 2024 | By 23 Jan 2025 | After 23 Jan 2025 | |
| Canada Delegates | CAD 1,895 | CAD 2,095 | CAD 2,195 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at [email protected] or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Canada Clinical Trial Regulations and Compliance Reviews and Testimonials
Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
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Canada Clinical Trial Regulations and Compliance
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