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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 »

The Role of Statistics in Pharmaceutical Quality Assurance

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 »

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 »

A Day in the Life of a Pharmaceutical Regulatory Affairs Pro

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 »

Becoming an Effective Scientific Communicator During a Regulatory Affairs Program

The field of regulatory affairs is full of technicalities surrounding the development of pharmaceutical products. Regulatory professionals are responsible for liaising with pharmaceutical companies, manufacturers and global regulatory authorities to navigate the process of approving new products for the market.  While engaging with others in the global healthcare field, regulatory affairs professionals also work on developing important documentation that details pharmaceutical guidelines and reports. Both verbal and written communication are essential skills for anyone looking to lead scientific conversations that determine the approval of new products on the healthcare market. If you’re training in the field of regulatory affairs, discover.. READ MORE »

Taking Clinical Research Courses? The Importance of Subject Screening in Clinical Trials

If you’re interested in clinical research, you’ll probably be responsible for facilitating a clinical trial throughout your career. Clinical trials are research studies conducted with people. They are used by researchers as a means of determining the effectiveness of a new drug, medical device, or another form of treatment for public use. Clinical trials are vital in the field of medical research, as they are the primary method of obtaining useful information about how a treatment behaves in humans.  As a clinical researcher conducting clinical trials, one of the processes you may be responsible for organizing is subject screening. Subject.. READ MORE »

3 Fields Where You Can Apply Your HPLC Training

HPLC stands for High-Performance Liquid Chromatography – a technique for separating organic compounds in order to analyze them. Today, it can be used for separation, identification, purification, and quantification. Due to its accuracy and precision, HPLC has become a popular method of examining samples across many industries.  HPLC is frequently used in pharmaceutical research, as well as the health and food industries for analyzing the nutritional benefits of different foods and enforcing food safety standards. With the right training, you’ll be equipped to work in professional laboratories across various fields. Read on for a closer look at where your career.. 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 »

Exploring the Impact of Ultrasonic Energy for Cannabis Quality Assurance

Quality departments within the cannabis market are responsible for conducting and monitoring activities that affect the quality, safety, or efficacy of cannabis products. Related to this area, ultrasonic energy has a number of uses in both cannabis testing and production labs. Ultrasonic energy has long been an excellent method of cleaning lab equipment and removing contaminants from virtually any product, but it can be used in several ways to ensure that a cannabis product is of the highest quality.  For that reason, many cannabis businesses today are turning to ultrasonic energy to extract and process their cannabis products. For those.. READ MORE »