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Posts Tagged: Regulatory affairs

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 »

Studying Drug Regulatory Affairs? Here Are the Pros & Cons of Generic Drugs

Many individuals associate name brands with quality, and will only substitute brands with cheaper generic equivalents if they can be convinced that doing so is not a downgrade. When it comes to medicine, the dilemma of whether to choose a generic or name brand can be especially difficult. Generic drugs are typically less expensive than the name brands that they replace. However, medicine is not something that many people want to experiment with. If a generic drug doesn’t work as well, the difference could have serious repercussions on a person’s health. Are you considering regulatory affairs training? Read on to.. READ MORE »

A Closer Look at Canada’s Thriving Medical Device Market for Pros in Regulatory Affairs

In hospitals and doctors’ offices, drugs aren’t the only things responsible for helping patients heal and feel better. Medical devices are a huge category of medical care tools that often go unnoticed, but are crucial to modern day medicine. Medical devices include wheelchairs, medical scissors, and even bandages. They can range from low-tech to high-tech devices and can even include pacemakers. Some of the technologies used to produce them include microelectronics, biotechnology, and even software. Unlike drugs, which dissolve and are absorbed by the body, medical devices are instruments, tools, and implants that can help with everything from diagnosing a.. READ MORE »

3 Skills It Takes to Succeed on the Regulatory Affairs Career Track

Regulatory affairs is a relatively new and demanding career. It requires extensive knowledge of the business, legal, and pharmaceutical aspects of products in development, so that projects can be operated smoothly from inception to market. A regulatory affairs specialist is responsible for keeping up-to-date with all of the rules and regulations that govern the production process for new drugs, cosmetics, and other medical products. And while it is an incredibly rewarding career both emotionally and financially, there are some specific skills that can help you succeed in this profession. If you’re interested in a career that encompasses the specifics of.. READ MORE »

A Guide to Global Pharmaceutical Regulations for Regulatory Affairs Students

Today’s pharmaceutical industry is very much a global market. While traditional economic powers like the United States remain leaders in the field, new drug development, manufacturing, and trade is now taking place in increasingly diverse parts of the world. In fact, the emerging markets China and Brazil are now home to the 3rd and 6th largest pharmaceutical industries in the world. Not only that, but companies are now manufacturing and developing drugs for distribution to a variety of different countries, each with their own regulations and guidelines. As a result, professionals in the regulatory affairs industry now face a tougher.. READ MORE »

Regulatory Affairs Spotlight: How New Drug Development Works

Drug research is essential to helping medicine advance and finding new ways of fighting illness, but it is a long and complicated process. Just one in every 5,000 compounds that enters preclinical testing actually make it to the marketplace, and companies spend approximately US$500 million per product, with studies taking anywhere from 8 to 15 years. For regulatory affairs professionals involved in new drug development, the barriers to making potentially beneficial products available to the public can sometimes be frustrating. Nevertheless, the regulations are necessary to ensure that drugs are safe and effective. So how does a new drug get.. READ MORE »

Preparing for a Regulatory Affairs Job Interview

A career in Regulatory affairs involves doing research and other work that directly impacts the lives of others. If you choose to pursue this career path, you’ll be involved in the research and development of pharmaceuticals, natural products, cosmetics and supplements. On any given day, you’ll be in charge of compiling safety information about a product, negotiating with authorities who control licencing, overseeing clinical trials, and much more. If you are planning to pursue regulatory affairs courses, or have already begun your program, read on to find out what steps you can take to prepare for a job interview once.. READ MORE »

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