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Posts Tagged: pharmaceutical regulatory affairs

3 Questions About Generic Drugs Answered for Those Interested in Regulatory Affairs

Generic drugs, despite how they may appear, are not very different from brand-name medicines. That’s because they’re designed to replicate the same dosage form, strength, quality performance, and intended use. They also produce the same effects, since both drugs contain the same active ingredients.  Because they’re fundamentally alike, generic drugs can serve as an alternative version of the brand-name drug. The distinguishing feature comes from the different names. Typically, a brand-name drug is protected by a patent. When that patent expires, other manufacturers can reproduce the brand-name drug and sell a generic version of it.  Interested in pharmaceutical regulatory affairs?.. READ MORE »

The Natural Health Product Approval Process Explained for Those in Regulatory Affairs

Across Canada, Natural Health Products (NHPs) are regulated to help protect consumers and provide safe and effective products to the public. The Canadian government worked closely with consumers, academics, healthcare practitioners, and industry stakeholders to come up with the standard guidelines that are in effect today. As a future regulatory affairs professional, it is important to understand these regulations as they apply to each company and product within the industry.  At AAPS, our Regulatory Affairs program helps students become familiar with regulatory systems, legislation, and practices that relate to the development, quality, and manufacture of pharmaceutical goods. With a course.. READ MORE »

Why Regulatory Affairs Professionals Will See an Upward Trend in BioPharma Products for Approval

Within the field of Pharmaceutical Regulatory Affairs, professionals use their knowledge of industry legislation, manufacturing practices, quality standards and regulatory systems to assess the safety of pharmaceutical products which require approval for the market. While all of the products they’ll review are pharmaceuticals, some of these products will fall under the category of biopharmaceuticals.  Biopharmaceuticals are produced using biotechnology. With new technologies, more efficient processes and innovative biologies, these products have greater potential on the market than ever before. If you’re considering a career in Pharmaceutical Regulatory Affairs, your future role may involve ensuring the safe and compliant development of.. READ MORE »

Preclinical Vs. Nonclinical Studies: A Guide for Regulatory Affairs Students

If you’re studying regulatory affairs, you’ve probably already encountered a host of industry-specific terms used to denote different pharmaceutical practices, processes, compliances, measures, devices and more. Within the industry, agreed-upon definitions are developed in order to keep communication aligned and reduce misinterpretations. Upon entering a career in regulatory affairs, maintaining familiarity with common terms will not only help you to avoid confusion but to ensure the safe and lawful operation of the pharmaceutical organization you’re working with.  In the field of pharmaceutical development and regulatory affairs, there are some terms that are frequently conflated. While often used interchangeably in the.. READ MORE »

Studying Regulatory Affairs? Here’s a Look at the Top Biotech Trends in 2021

The biotech industry experiences constant change with progressive knowledge and research emerging in the field every year. Because of these advancements, people are able to receive clearer diagnoses and find more effective treatment options for their conditions.  A certification in regulatory affairs will allow you to enter the biotech industry with knowledge on a wide range of regulations and standards, such as: Regulatory submissions Post-approval activities Regulatory compliance The Canadian Food and Drugs Act Global Regulatory Strategies Students in this program will earn a certification covering 10 different modules to prepare them for a career in regulatory affairs. With extensive.. READ MORE »

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 »

Taking Pharmaceutical Courses? Learn How Penicillin Made Pharmaceutical History

Since its discovery nearly a century ago, penicillin has been used around the world as the choice antibiotic of physicians for treating all kinds of bacterial illnesses and infections. The effectiveness of this antibiotic class-type remains unmatched, unique in its ability to inhibit various types of harmful bacterial strains. It’s also been credited as the interventive cure to many once deadly diseases. So how did this antibiotic, considered to this day as no less than miraculous, come to be? As it happens—quite by accident. We take a closer look at the intriguing history of penicillin here for those taking pharmaceutical.. READ MORE »

NSAIDs Explained for Those Attending Pharmaceutical Courses

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are one of the most common medications used by many to treat mild to moderate pain. As some of them are considered over-the-counter drugs, they’ve become increasingly relied upon by the average consumer for quick pain relief. As such, understanding how NSAIDs work and what sets them apart from other medications can be extremely valuable for students interested in pharmacology. During your pharmaceutical or regulatory affairs program, you’ll be introduced to key regulatory systems, legislations, and practices that directly affect the development and quality of pharmaceutical products. Here’s a closer look at NSAIDs for those studying.. READ MORE »

How Professionals with Careers in Regulatory Affairs Regulate Vaccines

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 »