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Posts Tagged: Regulatory affairs

3 Reasons to Become a Regulatory Affairs Associate After Our Training

The field of regulatory affairs has been growing in recent years with the constant innovation and developments of the pharmaceutical industry. At the Academy of Applied Pharmaceutical Sciences, our postgraduate online diploma program provides the comprehensive background and training required to address domestic and international regulatory statutes and laws. With the opportunity for extensive growth in this field, many students quickly realize that the path to a regulatory affairs associate is for them. Continue reading to discover the value of pursuing a role in regulatory affairs after completing the AAPS diploma program. 1. Become Well-Versed in a Wide Variety of.. READ MORE »

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 »

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 »