Regulatory Affairs is an important aspect of the pharmaceutical industry. As a professional in a regulatory affairs role, you’ll play a crucial role in ensuring that pharmaceutical products are manufactured and distributed in compliance with industry regulations. Your work will confirm that pharmaceutical drugs and medical products are safe and effective for human use. The scope of Regulatory Affairs is wide, as it’s essential to ensure compliance at every stage of the development process, including the testing, manufacturing, marketing, and distribution stages. If you’re wondering what a career in Regulatory Affairs could look like, read on to discover a few.. READ MORE »
Traditionally, pharmaceutical excipients are known for being non-medicinal components of a pharmaceutical product. Although they aren’t typically supposed to cause a reaction of any kind, they are a necessary part of a pharmaceutical product’s manufacturing phase. Excipients also help with breaking the product down in the user’s stomach, binding ingredients together, and stabilizing the product. As a student in regulatory affairs, you can learn how to ensure any pharmaceutical product adheres to federal and/or provincial regulations, and how to know when pharmaceutical excipients cause an adverse reaction. Here’s what students interested in regulatory affairs courses should know about pharmaceutical excipients… READ MORE »
Navigating the aisles of the pharmacy can be overwhelming. A customer looking to purchase some acetaminophen to relieve their headache is confronted with shelves stocked full of different versions of the substance from a variety of different brands. Though they may be more familiar with the Tylenol product, there is no significant difference between it and the plainer versions of the drug sitting next to it. Functionally, both drugs are the same, though there is a good reason both exist. Professionals who work in pharmacovigilance and regulatory affairs are invested in the compliance of pharmaceutical and healthcare products with the.. READ MORE »
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 »
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 »
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 »
High sanitation standards are required during drug manufacturing, and regulatory affairs workers pay close attention to these Health Canada guidelines.
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 »
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 »
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 »
