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 »
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 »
Pharmacokinetics (PK) and pharmacodynamics (PD) are two core concepts of pharmacology and they are especially important for drug safety and pharmacovigilance. These concepts tell researchers a lot about how drugs move in and interact with the human body, which in turn helps scientists, doctors, and pharmacists know how drugs can be used safely by patients. Below we will compare PK and PD and take a look at why they are both so important for creating safe and effective pharmaceuticals. Both PK and PD Are Equally Important for Pharmacovigilance Certificate Students to Know Both PK and PD are considered to be.. READ MORE »
The United States-Mexico-Canada Agreement (USMCA) is a free trade deal recently signed between North America’s three largest countries. Once ratified, it will replace the North American Free Trade Agreement (NAFTA) and it has major implications for the pharmaceutical industry, especially in terms of intellectual property rights. In its current form, the USMCA could significantly change how pharmaceutical companies sell their products in Canada. Here’s what you need to know about the USMCA if you’re studying regulatory affairs. The USMCA Will Extend Patent Protections for Biologics to 10 Years The USMCA will extend the patent protection period for biologics—which are pharmaceutical.. READ MORE »
The pharmaceutical industry is an innovative and rapidly evolving sector, but one area of advancement that some pharmaceutical students may be less familiar with is the recent and ongoing development of smart packaging. Smart packaging can be used for a number of purposes. It could help increase patient compliance, which is a benefit not only for pharmaceutical companies but also for patients themselves. It could offer a form of validation to help consumers steer clear of counterfeit drugs, which can pose substantial health risks. It could also offer consumers information about whether a product has been tampered with and whether.. READ MORE »
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 »
The review of prescription and non-prescription drugs authorized is a long and intricate process, from research and development to clinical trial to ending up on the shelves of local pharmacies. Often, due to a variety of reasons, many drugs do not make it to market, and fail to be approved for public use. Here are some aspects of the regulatory process students interested in regulatory affairs should know. Therapeutic Value and Product Effectiveness The effectiveness of a drug allows it to pass clinical trials. Its success relies upon its therapeutic value, or how efficient the drug is at treating the.. READ MORE »
International co-operation has become the political norm after both world wars highlighted the dire consequences of division between powerful countries. Global organizations, like the United Nations (UN), serve a vital purpose in quelling potential tension between states and in promoting international collaboration. This type of collaboration has also led to proactive steps being taken in the battle against deadly diseases, through the establishment of the World Health Organization (WHO). The remit of the WHO has developed over the decades since its creation. It also makes significant attempts to ensure the safety of medicines produced and administered in its 193 member.. READ MORE »
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