Clinical Safety and Pharmacovigilance Certificate courses are formatted to help students gain specialized knowledge of the most recent developments in clinical research, drug development, and pharmacovigilance. One of the biggest developments and an ongoing topic of interest in clinical research is medical devices. As technology advances, new medical devices are introduced and must undergo the approval process for use in the healthcare industry.
Our courses outline both Canadian healthcare as well as the global healthcare system, giving students an understanding of the relationship between international guidelines and standard operating procedures in regards to medical devices. With extensive hands-on training at AAPS, students gain the confidence to pursue career opportunities in different industries, including pharmaceutical, biotechnological, cosmetics, and natural health products. Read on for an exploration of medical devices to complement your clinical research training.
The Classification of Medical Devices for Students in a Clinical Research Program
If you’re considering a clinical research program, you’ll need to understand what medical devices are and how they are classified. Medical devices include a wide range of health and medical instruments used in the treatment, diagnosis, or prevention of a disease or physical condition. These can be as simple as tongue depressors and thermometers, and as complex as robotic surgery devices.
Students in Clinical Safety and Pharmacovigilance Certificate courses will focus on a number of topics presented over 15 modules. In your Medical Devices module, you’ll explore the classification of these devices based on their specificity.
Classification of medical devices is as follows:
- Class I medical devices perform general controls and most are exempt from premarket submissions
- Class II medical devices perform special controls and require premarket notification
- Class III medical devices require premarket application and approval
You will also have the opportunity to explore current clinical research related to medical devices, giving you an understanding of the importance of regulating medical devices for safety monitoring and reporting.
Medical Devices Must Undergo Clinical Trials
Clinical trials are investigational tests performed to determine the safety and effectiveness of a medical device. Trials are performed on devices that are not yet available in the region, and the results provide information on the risks and benefits of their use.
When you pursue clinical research training at AAPS, you will have the opportunity to complete a module on Clinical Project Management and Project Chart Development. This unique course exposes students to the process of implementing, monitoring, and managing a clinical study.
Upon completion of this course and its practical components, you will be equipped with the skills to design and implement a plan for a clinical research project. This will give you relevant experience for career paths in Big Pharma, Canadian biotech companies, and contract research organizations (CROs).
Understanding the Results of Clinical Trials and What They Mean for Market Approval
There are various stages of review needed for the Premarket Approval Application (PMA) of medical devices. This four-step review process consists of:
- Pre-substantive review
- Investigational device exemption
- Request for premarket approval
- Request for approval for device change
When you attend AAPS, you’ll complete a module on Clinical Research SOP Development. This course will give you real-world experience with reporting adverse events, surveilling post-market performance, and summarizing product characteristics.
Understanding the importance of clinical trial results at every stage will prepare you for careers in clinical research, drug safety, and pharmacovigilance. Our certificate courses will give you the knowledge to play a vital role in protecting study participants and the general population when it comes to marketed drugs.
Interested in clinical research courses in Toronto?
Contact AAPS for more information!