The field of regulatory affairs is full of technicalities surrounding the development of pharmaceutical products. Regulatory professionals are responsible for liaising with pharmaceutical companies, manufacturers and global regulatory authorities to navigate the process of approving new products for the market. While engaging with others in the global healthcare field, regulatory affairs professionals also work on developing important documentation that details pharmaceutical guidelines and reports. Both verbal and written communication are essential skills for anyone looking to lead scientific conversations that determine the approval of new products on the healthcare market. If you’re training in the field of regulatory affairs, discover.. READ MORE »
The pharmaceutical industry is responsible for the development and distribution of medical drugs. Bringing a drug to the market involves navigating a range of different compliance issues. When a new product is developed globally, pharmaceutical companies are tasked with creating and implementing a regulatory strategy. As the market is constantly evolving, the government regulations of a country are subject to change. To navigate this, knowledge of the global market conditions from the perspective of both healthcare providers and patients is essential when outlining a regulatory strategy. With an effective strategy in place, industry professionals save time and money, while improving.. READ MORE »
You may be familiar with the development of animal cloning over time, such as Dolly the sheep, which was cloned in 1996. However, what you might not be familiar with is how this practice relates to food safety and food supply. When an animal is cloned, their genetic makeup is copied via the replacement of an egg cell’s nucleus with that of a mature somatic cell, with no need for an egg-sperm union. The subsequent DNA transfer leads to a new embryo, which is then transferred to a surrogate before eventually being delivered. Cloning animals for food production hasn’t been.. 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 »
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 »
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 »
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 »
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 »
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 »
