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 Academy of Applied Pharmaceutical Sciences (AAPS) is thrilled to announce that its highly anticipated course, “CR015 – Legislation, Ethics, and GVP” has received official accreditation from the Canadian Council on Continuing Education in Pharmacy (CCCEP). About The Course This live online program, designed specifically for pharmacists, offers a comprehensive introduction to international regulations and guidelines for good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products. Participants in this cutting-edge course will have the opportunity to delve into the entire EMA Good Pharmacovigilance Practices (GVP) based on ICH guidelines and be prepared to be.. READ MORE »
February is Black History Month and we want to spend some time highlighting a few of the african-american contributions to the world of science and pharmaceuticals! ✊ As we celebrate #blackhistorymonth here at AAPS we are taking time to highlight black contributions to science and the pharmaceutical industry! 👏 George Washington Carver George Washington Carver was an American agricultural scientist and inventor who promoted alternative crops to cotton and methods to prevent soil depletion. He was one of the most prominent black scientists of the early 20th century and the impacts of his work are still seen today. Marie Maynard.. 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 »
When a drug is given regulatory approval to enter the marketplace, a much broader patient population than documented in clinical trials is exposed to the product. Not only is there less control on drug prescription than in a clinical trial, but there is also the chance that certain populations taking the drug may not have been closely studied. Sometimes, rare adverse effects are not even discovered until a product is in its post-approval phase. As a regulatory affairs professional, you will play an important role in ensuring that pharmaceutical companies keep public safety a priority even after a drug is.. 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 »
A fundamental requirement of the pharmaceutical industry is to ensure the safety and effectiveness of products. Pharmaceutical quality assurance is a vital step in this process and helps to keep all steps and processes in line with good manufacturing practices (GMP). When documentation and data are consistently accurate, then pharmaceutical companies are able to operate and perform as expected. Within pharmaceutical quality assurance roles, this tracking of data is where statistics comes into play. Statistical methods are essential to the operations of any pharmaceutical manufacturing facility, ensuring alignment with standards of quality. Especially considering advancements in technology, coupled with new.. 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 »
As a professional working in pharmaceutical regulatory affairs, a day on the job is never dull. Pharmaceutical regulatory affairs specialists have a wide range of responsibilities – all revolving around the safety of the pharmaceutical products dispensed by their respective facilities. After completing your regulatory affairs training, you’ll possess strong knowledge of legislation, regulatory systems and practices, enabling you to successfully monitor the safe development and manufacturing of pharmaceutical products, including oral drugs, topical medicines, and more. If you’re considering training for this career path, previewing a typical day on the job will help you make a more informed decision.. READ MORE »
