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Posts Tagged: Regulatory affairs courses

Studying Regulatory Affairs? Uncover Key Insights on Regulatory Labelling

Regulatory affairs play a key role in ensuring the public’s safety and well-being, affecting the pharmaceutical and health industry in profound ways. Those interested in studying regulatory affairs are able to better understand regulatory systems, legislations, and practices that impact the development and quality of pharmaceutical goods.  Here, students have the opportunity to explore regulatory labelling—which is essential across a wide range of industries, especially in the pharmaceutical world. With this background, students can better understand (and consequently meet) the labelling and product summaries requirements after completing the program. Equipped with this knowledge, students can become professionals who are ready.. READ MORE »

A Brief Guide to Global Regulatory Strategies for Students in Regulatory Affairs

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 »

How CRISPR is Changing Biotechnology: An Overview for Students in Regulatory Affairs

Many industries are at the cusp of change as technology continues to grow, introducing new tools that can significantly impact people’s health. Similarly, biotechnology is becoming a larger part of the pharmaceutical industry, thus impacting regulatory requirements.  Individuals keen on developing a stronger understanding of these requirements can explore the field of regulatory affairs—studying a wide range of regulations and standards, including regulatory legislation and practices, that shape the development and quality of pharmaceutical goods. This includes biologics and biotechnology products, like CRISPR, which have the power to change the future of the pharmaceutical industry.  Read on to discover how.. READ MORE »

How COVID is Changing the Landscape for Regulatory Affairs Program Graduates

The onset of the COVID-19 pandemic has brought unforeseen changes to global drug development and its regulatory processes. As the effects of the pandemic continue to linger around the world, the need to understand the virus and develop treatments at a rapid pace has provided new learning opportunities for the pharmaceutical industry. Companies have glimpsed ways they can improve upon traditional methods to offer a competitive service, while complying with industry regulations. The need for global platforms, decentralized trials, efficient technology, and adaptable regulations are among some of the top concerns being addressed by the industry since the arrival of.. READ MORE »

3 Careers You Can Pursue After Completing Your Regulatory Affairs Courses

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 »

What Are Pharmaceutical Excipients? A Brief Intro for Those Interested in Regulatory Affairs Courses

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 »

Brand-name vs. Generic Drugs: A Quick Look for Students in Regulatory Affairs Courses

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 »

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 »