Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are one of the most common medications used by many to treat mild to moderate pain. As some of them are considered over-the-counter drugs, they’ve become increasingly relied upon by the average consumer for quick pain relief. As such, understanding how NSAIDs work and what sets them apart from other medications can be extremely valuable for students interested in pharmacology. During your pharmaceutical or regulatory affairs program, you’ll be introduced to key regulatory systems, legislations, and practices that directly affect the development and quality of pharmaceutical products. Here’s a closer look at NSAIDs for those studying.. READ MORE »
A professional working in regulatory affairs has the task of ensuring that all kinds of products from cosmetics to pharmaceuticals to human and veterinary medicines meet legislative requirements. When it comes to vaccines, this process means reviewing emerging vaccines for safety, efficacy, and quality. The development of vaccines under normal circumstances requires trials involving thousands of people, and can take many years to approve under a stringent review process. In the face of COVID-19, many vaccines are currently being developed at a much quicker rate, presenting complicated challenges for both the manufacturers of these new products as well as the.. READ MORE »
Professionals working in regulatory affairs help to ensure that products and processes comply with the existing quality control laws and regulations. This ascertains that products are developed and sold in a safe and secure manner. This is especially important in the realm of pharmaceuticals, where products can sometimes be life-saving and their safety and efficacy is of utmost importance. Recently, biotechnology has picked up steam as a set of processes that can aid in the advancement of pharmaceutical development and innovation. Regulatory affairs professionals should be particularly interested in biotechnology for how these technologies may be monitored and standardized to.. READ MORE »
Working with regulatory systems requires a strong background in standards and regulations, so that you have a good understanding of how they function and how they can change. Pharmaceutical regulations dictate how Canadians can access the drugs that they need to be healthy and enjoy a high quality of life. When regulations are made, it is often to improve the process by which people receive their pharmaceutical products and make healthcare more effective. In the case of Canada’s Special Access Program, patients who haven’t been able to receive effective treatment with conventional therapies are given access to drugs not normally.. READ MORE »
Package inserts give valuable information to patients regarding their medication. Usually, this includes prescribing information, also called professional information. Prescribing information includes: Brand and name of drug Potency and/or ingredients Standard of manufacture and manufacturer or sponsor Function of the drug Precautions or warnings Dosage and instructions for administering the drug Storage information Date prepared and preparations available Package inserts also help health care professionals, as they include things like special instructions for drugs that require specific dispensing like injection. In many cases, a separate document specifically for consumer or patient information is included, either separate from or as part.. 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 »
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 and regulations of pharmaceutical products, instead of each region repeating the same processes on identical drugs. It’s a more efficient use of time and resources. Canada has a regulatory authority called the Health Products and Food Branch (HPFB) of Health Canada. The HPFB regulates MRAs that Canada is a part of. MRAs ensure Good Manufacturing Practices (GMPs) are followed and make it easier for people around the globe to access.. 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 »
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 more. In some cases, it may occur at the same time as or lead to anaphylactic shock, which is a drop in blood pressure to dangerously low levels that makes it difficult for organs to receive blood. In all cases, a severe allergic reaction is a medical emergency. Every year, approximately 3,500 Canadians will experience anaphylaxis. For the majority of those who do experience it, a nearby EpiPen quickly administered.. READ MORE »
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 »
