Regulatory submissions are a cornerstone of the pharmaceutical industry, and mastering this process is essential for regulatory affairs professionals. On November 8, 2024, AAPS hosted an insightful webinar on Drug Product Submission (NDS) Preparation in eCTD format. The webinar aims to equip participants with practical knowledge and skills for successful submissions. Here are the four key takeaways from this dynamic event. 1. Understanding the Importance of the Common Technical Document (CTD) One of the standout segments of the webinar focused on the Common Technical Document (CTD), a globally standardized format for regulatory submissions. Participants learned how the CTD facilitates organization.. READ MORE »
The Canadian Quality Assurance (QA) industry is tough to navigate, requiring more than just technical skills—it takes determination, education, and experience. Aishwarya Venkatasubramanian, a recent graduate of the AAPS Quality Assurance and Regulatory Affairs (QARA) post-graduate diploma program, exemplifies this. In this blog, we explore Aishwarya’s journey from biotechnology to a successful career in Quality Assurance, with comprehensive support from AAPS College. A Passion for Healthcare and Education Aishwarya’s passion for healthcare has driven her journey from completing a master’s in biotechnology in India to navigating new challenges in Canada. Upon arrival, she balanced her personal life and career ambitions,.. READ MORE »
Regulatory affairs officers play a vital role in ensuring that various products, including foods, cosmetics, pharmaceuticals, and veterinary medicines, comply with legislative requirements throughout their development, testing, and marketing processes. In other words, they navigate the complex landscape of regulatory requirements and help bring products to market smoothly. The Quality Assurance and Regulatory Affairs program at AAPS can equip budding regulatory affairs professionals with all the training necessary for a career in the industry. However, success as a regulatory affairs associate also relies on a diverse skill set encompassing technical and non-technical abilities. Technical skills such as regulatory knowledge and.. 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 »
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 »
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 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 »
