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Posts Tagged: Regulatory affairs

Studying Regulatory Affairs? The Importance of GMPs for Natural Health Products

The pharmaceutical world is bound by a number of rules and regulations designed to ensure both quality and safety when manufacturing new drugs. Natural health products (NHPs) are no exception. NHPs are defined as vitamins and minerals, herbal remedies, homeopathic medicines, probiotics, and other products like amino acids. Since NHPs don’t require a prescription for sale, they must be safe to use as over-the-counter remedies. This is where good manufacturing practices come into play. From quality and risk management to ongoing post-marketing activity, Good Manufacturing Practices (GMP) compliance is required at multiple stages of NHP production. This blog will explore.. READ MORE »

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 »

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 »

Animal Cloning’s Relevance to Regulatory Affairs

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 »

How Biotech Impacts Our Everyday Lives, as Explained to Those in Regulatory Affairs Training

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 »

A Quick Look at EpiPens for Those Interested in Pharmaceutical Regulatory Affairs

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 »

How Regulatory Affairs Professionals Ensure Effective Sanitation in a Pharmaceutical Lab

High sanitation standards are required during drug manufacturing, and regulatory affairs workers pay close attention to these Health Canada guidelines.

Groundbreaking Medical Devices That Students in Regulatory Affairs Should Know

The human body is resilient and capable of self-healing to amazing degrees, but it’s far from perfect. That’s why medical devices that can help the body heal from grave injuries, overcome serious illnesses, or that allow deeper looks into a person’s body are so common and important in today’s medicine. There are so many medical devices that do great things today that it would be impossible to discuss them all. Here, though, are a few examples of medical devices that are particularly valuable. Students in Pharmaceutical Regulatory Affairs Can See MRI Machines Are Vital to Modern Medicine Radiation-based scans, like.. READ MORE »