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Posts Tagged: Regulatory affairs courses

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 drugs and medical devices. New Drug Submissions are submitted to the TPD after three phases of clinical trials. The results from these trials need to be favourable, but once they have proven that the drug is safe enough to be submitted, the manufacturer will submit a New Drug Submission. These are important documents, along with Clinical Trial Applications (CTAs), Common Technical Documents (CTDs), and other regulatory requirements. If you’re studying.. READ MORE »

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 for humans at or after birth, diagnoses pregnancy or restores, modifies, or corrects body structure Some examples of medical devices include pacemakers, cardiovascular stents, respiratory ventilators, or even small items like tongue depressors or bandages. With new regulations coming into play later in 2019, read on for how this could affect regulatory affairs! What Are some Medical Device Safety Issues? Unfortunately some medical device issues can arise, which has led.. READ MORE »

What Students in Regulatory Affairs Courses Should Know About the USMCA Trade Deal

The United States-Mexico-Canada Agreement (USMCA) is a free trade deal recently signed between North America’s three largest countries. Once ratified, it will replace the North American Free Trade Agreement (NAFTA) and it has major implications for the pharmaceutical industry, especially in terms of intellectual property rights. In its current form, the USMCA could significantly change how pharmaceutical companies sell their products in Canada. Here’s what you need to know about the USMCA if you’re studying regulatory affairs. The USMCA Will Extend Patent Protections for Biologics to 10 Years The USMCA will extend the patent protection period for biologics—which are pharmaceutical.. READ MORE »

How Regulatory Affairs Professionals Ensure Effective Sanitation in a Pharmaceutical Lab

High sanitation standards are required during drug manufacturing, and regulatory affairs workers pay close attention to these Health Canada guidelines.

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 their trigger or take medication to prevent symptoms. But what if there was another way? Some researchers claim there might be, pointing to gene therapy as a potential avenue for not only helping people manage their allergies, but for banishing allergies forever. Sound interesting? Here’s what students of pharmaceutical regulatory affairs need to know about the potential for gene therapy to treat allergies. Gene Therapy for Allergies Would “Retrain” Immune.. READ MORE »

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 vitro probably rings a bell, as it’s commonly referred to as a means of helping with infertility. While in vitro fertilization is surely important in the medical and science communities, in vitro studies go far beyond just that. In vitro and in vivo studies can be used to test potentially life-changing pharmaceutical products, and each testing method has its own benefits and drawbacks. If you’re considering a career in the.. READ MORE »

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 healthier lives. But if individuals taking pharmaceuticals and the doctors who are prescribing them don’t have the proper information, issues may arise. This is why Health Canada ensures most approved drugs have a product monograph. A product monograph is a government-regulated scientific document that lists the drug, its properties, and any health claims the product makes. It includes essential information for doctors and healthcare professionals which allows them to make.. READ MORE »

A Closer Look at Canada’s Thriving Medical Device Market for Pros in Regulatory Affairs

In hospitals and doctors’ offices, drugs aren’t the only things responsible for helping patients heal and feel better. Medical devices are a huge category of medical care tools that often go unnoticed, but are crucial to modern day medicine. Medical devices include wheelchairs, medical scissors, and even bandages. They can range from low-tech to high-tech devices and can even include pacemakers. Some of the technologies used to produce them include microelectronics, biotechnology, and even software. Unlike drugs, which dissolve and are absorbed by the body, medical devices are instruments, tools, and implants that can help with everything from diagnosing a.. READ MORE »

3 Skills It Takes to Succeed on the Regulatory Affairs Career Track

Regulatory affairs is a relatively new and demanding career. It requires extensive knowledge of the business, legal, and pharmaceutical aspects of products in development, so that projects can be operated smoothly from inception to market. A regulatory affairs specialist is responsible for keeping up-to-date with all of the rules and regulations that govern the production process for new drugs, cosmetics, and other medical products. And while it is an incredibly rewarding career both emotionally and financially, there are some specific skills that can help you succeed in this profession. If you’re interested in a career that encompasses the specifics of.. READ MORE »

5 Things You Should Know About the FDA if You’re Taking Regulatory Affairs Courses

Many pharmaceutical products developed and manufactured in Canada are exported to the United States. As a result, while Canadian regulatory affairs professionals answer primarily to Health Canada, they must also pay special attention to the department’s U.S. equivalent, the Food and Drug Administration (FDA). The FDA officially came into being in 1906, after the Food and Drug Act was signed into law, with the aim of overseeing products and ensuring a high standard of “strength, quality and purity.” Over the years, the department’s powers have expanded significantly, and today the FDA regulates everything from food and drug products to potentially.. READ MORE »

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