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Posts Tagged: pharmaceutical regulatory affairs

Getting Your Regulatory Affairs Certification? Canada’s Special Access Program May Interest You

Working with regulatory systems requires a strong background in standards and regulations, so that you have a good understanding of how they function and how they can change. Pharmaceutical regulations dictate how Canadians can access the drugs that they need to be healthy and enjoy a high quality of life. When regulations are made, it is often to improve the process by which people receive their pharmaceutical products and make healthcare more effective. In the case of Canada’s Special Access Program, patients who haven’t been able to receive effective treatment with conventional therapies are given access to drugs not normally.. READ MORE »

What to Know About Package Inserts if You’re Considering a Regulatory Affairs Program

Package inserts give valuable information to patients regarding their medication. Usually, this includes prescribing information, also called professional information. Prescribing information includes: Brand and name of drug Potency and/or ingredients Standard of manufacture and manufacturer or sponsor Function of the drug Precautions or warnings Dosage and instructions for administering the drug Storage information Date prepared and preparations available Package inserts also help health care professionals, as they include things like special instructions for drugs that require specific dispensing like injection. In many cases, a separate document specifically for consumer or patient information is included, either separate from or as part.. READ MORE »

Why Drug Submissions Are Important for Careers in Regulatory Affairs

Canada’s Food and Drug Regulations place requirements on new drugs to ensure that they satisfy the standards for market release. In addition, the Therapeutic Products Directorate (TPD) regulates Canada’s prescription drugs and medical devices. New Drug Submissions are submitted to the TPD after three phases of clinical trials. The results from these trials need to be favourable, but once they have proven that the drug is safe enough to be submitted, the manufacturer will submit a New Drug Submission. These are important documents, along with Clinical Trial Applications (CTAs), Common Technical Documents (CTDs), and other regulatory requirements. If you’re studying.. READ MORE »

Why Mutual Recognition Agreements Matter in Pharmaceutical Regulatory Affairs

Mutual Recognition Agreements, or MRAs, help streamline the regulation of pharmaceuticals by establishing better cooperation between governments. This cooperation means that countries and regions can rely on one another’s testing and regulations of pharmaceutical products, instead of each region repeating the same processes on identical drugs. It’s a more efficient use of time and resources. Canada has a regulatory authority called the Health Products and Food Branch (HPFB) of Health Canada. The HPFB regulates MRAs that Canada is a part of. MRAs ensure Good Manufacturing Practices (GMPs) are followed and make it easier for people around the globe to access.. READ MORE »

What New Medical Device Rules Mean for Students in Pharmaceutical Regulatory Affairs

A medical device is defined by Health Canada as: an instrument, apparatus, or other similar article diagnoses, treats, mitigates, or prevents conditions and diseases in human beings, prevents conception, cares for humans at or after birth, diagnoses pregnancy or restores, modifies, or corrects body structure Some examples of medical devices include pacemakers, cardiovascular stents, respiratory ventilators, or even small items like tongue depressors or bandages. With new regulations coming into play later in 2019, read on for how this could affect regulatory affairs! What Are some Medical Device Safety Issues? Unfortunately some medical device issues can arise, which has led.. READ MORE »

A Quick Look at EpiPens for Those Interested in Pharmaceutical Regulatory Affairs

Across the country, many Canadians live with serious allergies capable of leading to anaphylaxis. This is an extreme allergic reaction that includes symptoms such as headaches, difficulty breathing, hives, and more. In some cases, it may occur at the same time as or lead to anaphylactic shock, which is a drop in blood pressure to dangerously low levels that makes it difficult for organs to receive blood. In all cases, a severe allergic reaction is a medical emergency. Every year, approximately 3,500 Canadians will experience anaphylaxis. For the majority of those who do experience it, a nearby EpiPen quickly administered.. READ MORE »

Could Gene Therapy Cure Allergies? Students in Regulatory Affairs Courses, Find Out

For sufferers, allergies can be anything from annoying to deadly. In any case, they usually require extra care on the part of the person with the allergy to either avoid their trigger or take medication to prevent symptoms. But what if there was another way? Some researchers claim there might be, pointing to gene therapy as a potential avenue for not only helping people manage their allergies, but for banishing allergies forever. Sound interesting? Here’s what students of pharmaceutical regulatory affairs need to know about the potential for gene therapy to treat allergies. Gene Therapy for Allergies Would “Retrain” Immune.. READ MORE »

Groundbreaking Medical Devices That Students in Regulatory Affairs Should Know

The human body is resilient and capable of self-healing to amazing degrees, but it’s far from perfect. That’s why medical devices that can help the body heal from grave injuries, overcome serious illnesses, or that allow deeper looks into a person’s body are so common and important in today’s medicine. There are so many medical devices that do great things today that it would be impossible to discuss them all. Here, though, are a few examples of medical devices that are particularly valuable. Students in Pharmaceutical Regulatory Affairs Can See MRI Machines Are Vital to Modern Medicine Radiation-based scans, like.. READ MORE »

Comparing in Vitro & in Vivo for Students in Regulatory Affairs Courses

While there are hundreds of different types of experiments and studies, they can almost all fit into two main categories: in vitro and in vivo. To the untrained ear, in vitro probably rings a bell, as it’s commonly referred to as a means of helping with infertility. While in vitro fertilization is surely important in the medical and science communities, in vitro studies go far beyond just that. In vitro and in vivo studies can be used to test potentially life-changing pharmaceutical products, and each testing method has its own benefits and drawbacks. If you’re considering a career in the.. READ MORE »

Studying Drug Regulatory Affairs? Here Are the Pros & Cons of Generic Drugs

Many individuals associate name brands with quality, and will only substitute brands with cheaper generic equivalents if they can be convinced that doing so is not a downgrade. When it comes to medicine, the dilemma of whether to choose a generic or name brand can be especially difficult. Generic drugs are typically less expensive than the name brands that they replace. However, medicine is not something that many people want to experiment with. If a generic drug doesn’t work as well, the difference could have serious repercussions on a person’s health. Are you considering regulatory affairs training? Read on to.. READ MORE »

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