Regulatory approval is an essential stop in the journey from drug/product discovery to development and market launch. This informs the need for a rigorous regulatory affairs documentation process to ensure the correct information is accounted for. The work of regulatory affairs document reviewers requires them to possess several critical skills to function optimally. While these skills come naturally to some, they can be acquired through the right regulatory affairs training. Here, we discuss a few of the most important skills needed to carry out regulatory affairs document reviews successfully. What Does a Regulatory Affairs Document Review Entail A regulatory affairs.. READ MORE »
The cosmetic industry is a booming global industry worth billions of dollars, with an extensive range of products, including makeup, skincare, fragrances, and hair care. According to Statista, there are over 2500 cosmetics stores in the country, and the Canadian cosmetics market is expected to grow to roughly 1.7 billion dollars by 2027. Having said that, regulating cosmetic products is a complicated process, with several regional and international regulatory bodies enforcing strict rules and guidelines to ensure product safety and efficacy. These guidelines ensure that companies comply with regulations and standards, and regulatory affairs professionals have been tasked with enforcing.. READ MORE »
Once you’ve earned your Regulatory Affairs diploma, you will have the knowledge and skills required to navigate the complex and ever-changing world of regulatory compliance in industries such as the pharmaceutical, biotechnological, medical device, and natural health product industries. Each of these industries offers unique challenges and rewards, and each requires Regulatory Affairs professionals who are knowledgeable, skilled, and dedicated to ensuring that products are safe, effective, and in compliance with all necessary regulations. Whether you are interested in working for a large multinational corporation or a small start-up, there is a role for you in this field. The intense,.. READ MORE »
The medical device field is a vast industry that is responsible for meeting the demands of evolving patient needs with innovation and the use of advanced technology. If you’re looking to pursue a regulatory affairs program, then understanding the pressures that the medical device field is facing will help you navigate toward improved compliance, greater efficiency, and stronger collaboration. At the Academy of Applied Pharmaceutical Sciences, you can earn your diploma in regulatory affairs and explore the field of medical devices that fall outside the classification of drugs. Your Regulatory Affairs for Medical Devices course will take you through some.. READ MORE »
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 »
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 »
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 »
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 »
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 »
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 »
