Regulatory Affairs

Challenges Facing the Medical Device Field to Know for Regulatory Affairs Courses

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 »

A Look at Post-Approval Activities in Pharmaceutical Regulatory Affairs

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 »

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 »

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 »

5 Things for Students in Medical Device to Know About Drug Delivery Implants

Students in pharmaceutical school take note: pill regimens and daily injections could soon be replaced with advanced medical implants that do the dosing for you.