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Posts Tagged: Regulatory affairs certification

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 »

Getting Your Regulatory Affairs Certification? Canada’s Special Access Program May Interest You

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 »

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 »

Non-Approval of Drugs: A Helpful Explainer Before Studying for Regulatory Affairs Certification

The review of prescription and non-prescription drugs authorized is a long and intricate process, from research and development to clinical trial to ending up on the shelves of local pharmacies. Often, due to a variety of reasons, many drugs do not make it to market, and fail to be approved for public use. Here are some aspects of the regulatory process students interested in regulatory affairs should know. Therapeutic Value and Product Effectiveness The effectiveness of a drug allows it to pass clinical trials. Its success relies upon its therapeutic value, or how efficient the drug is at treating the.. 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 »

5 Things You Should Know About the FDA if You’re Taking Regulatory Affairs Courses

Many pharmaceutical products developed and manufactured in Canada are exported to the United States. As a result, while Canadian regulatory affairs professionals answer primarily to Health Canada, they must also pay special attention to the department’s U.S. equivalent, the Food and Drug Administration (FDA). The FDA officially came into being in 1906, after the Food and Drug Act was signed into law, with the aim of overseeing products and ensuring a high standard of “strength, quality and purity.” Over the years, the department’s powers have expanded significantly, and today the FDA regulates everything from food and drug products to potentially.. 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 »