Pharmaceutical Regulatory Affairs

Why Drug Submissions Are Important for Careers in Regulatory Affairs

Canada’s Food and Drug Regulations place requirements on new drugs to ensure that they satisfy the standards for market release. In addition, the Therapeutic Products Directorate (TPD) regulates Canada’s prescription…
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Why Mutual Recognition Agreements Matter in Pharmaceutical Regulatory Affairs

Mutual Recognition Agreements, or MRAs, help streamline the regulation of pharmaceuticals by establishing better cooperation between governments. This cooperation means that countries and regions can rely on one another’s testing…
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What New Medical Device Rules Mean for Students in Pharmaceutical Regulatory Affairs

A medical device is defined by Health Canada as: an instrument, apparatus, or other similar article diagnoses, treats, mitigates, or prevents conditions and diseases in human beings, prevents conception, cares…
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A Quick Look at EpiPens for Those Interested in Pharmaceutical Regulatory Affairs

Across the country, many Canadians live with serious allergies capable of leading to anaphylaxis. This is an extreme allergic reaction that includes symptoms such as headaches, difficulty breathing, hives, and…
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Could Gene Therapy Cure Allergies? Students in Regulatory Affairs Courses, Find Out

For sufferers, allergies can be anything from annoying to deadly. In any case, they usually require extra care on the part of the person with the allergy to either avoid…
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Groundbreaking Medical Devices That Students in Regulatory Affairs Should Know

The human body is resilient and capable of self-healing to amazing degrees, but it’s far from perfect. That’s why medical devices that can help the body heal from grave injuries,…
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Comparing in Vitro & in Vivo for Students in Regulatory Affairs Courses

While there are hundreds of different types of experiments and studies, they can almost all fit into two main categories: in vitro and in vivo. To the untrained ear, in…
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Studying Drug Regulatory Affairs? Here Are the Pros & Cons of Generic Drugs

Many individuals associate name brands with quality, and will only substitute brands with cheaper generic equivalents if they can be convinced that doing so is not a downgrade. When it…
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3 Facts About Product Monographs for Students in Regulatory Affairs Courses

Pharmaceuticals on the market have the ability to improve the lives of many Canadians. They are used to treat illness, pain, and disorders, and they help people live normal and…
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