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 »
Bioavailability is an important concept for those invested in drug safety and pharmacovigilance to be aware of. Verifying and regulating rates of bioavailability of a drug can ensure that clinically significant doses are being delivered to patients, or that toxic doses aren’t being accidentally delivered. For a drug with low bioavailability, a larger dose would be required to breach the threshold of minimum effective concentration. Bioavailability is, in essence, the rate and fraction at which a drug reaches systemic circulation unaltered. Certain drugs, such as those administered topically, do not require systemic circulation. For these, bioavailability will be irrelevant. However,.. 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 »
Counterfeit medications are a major problem for those working in drug safety. These professionals play a vital role in ensuring that the pharmaceutical products consumers use are safe, reliable, and effective. Counterfeit drugs can undermine the trust the public has in this system. The opioid crisis is compounding issues associated with counterfeit drugs. There is an increasing infiltration of the market by counterfeit prescription painkillers containing the opiate fentanyl. Counterfeit oxycodone tablets were found to contain fentanyl 89% of the time. This substance is several times more potent than oxycodone and can increase consumers’ risk of accidental overdose. Fentanyl is.. READ MORE »
Cannabis plants contain over 100 cannabinoids and terpenoids, including the most commonly known and extracted compounds: CBD and THC. Some extractions are “whole-plant,” meaning that no single chemical or compound is concentrated in the extraction process. However, most methods of extraction are designed to target specific components of the cannabis plant. Extractions from cannabis plants are used in all sorts of products, including oils and edibles, which offer an alternative to smoking the plant and, in some cases, offer different effects. Keep reading for an introduction to this important process! Learn the Extraction Factors to Consider in a Cannabis.. READ MORE »
Making plans to set up a grow room is exciting, highly detailed work. However, before you start cultivating cannabis, you must obtain licenses from Health Canada and the CRA unless the product contains less than 0.3 percent THC. When you have met the requirements of the authorities, only then can you follow through on your grow room plans. What do you have to consider as you set up your grow room? Essentially, your cannabis cultivation plans must take into consideration cost efficiency and plant health. These two major points encompass the wide range of elements that will factor into the.. 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 »
The World Health Organization (WHO) defines pharmacovigilance as: “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” It monitors the safety of all medicines, aiming to prevent Adverse Drug Reactions (ADRs) and improve upon the effectiveness and safety of drugs through monitoring. Pharmacovigilance occurs on a local, national, and international level. Thanks to the WHO Programme for International Drug Monitoring, pharmacovigilance is improved by a global collaborative network. The network spans over 150 countries. Read on for more background on pharmacovigilance, why it matters, and the role of a.. READ MORE »
