Regulatory Affairs Programs

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…
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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…
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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…
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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…
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What Students in Regulatory Affairs Courses Should Know About the USMCA Trade Deal

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)…
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Non-Approval of Drugs: A Helpful Explainer Before Studying for Regulatory Affairs Certification

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….
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How Regulatory Affairs Professionals Ensure Effective Sanitation in a Pharmaceutical Lab

High sanitation standards are required during drug manufacturing, and regulatory affairs workers pay close attention to these Health Canada guidelines.

A Closer Look at Canada’s Thriving Medical Device Market for Pros in Regulatory Affairs

In hospitals and doctors’ offices, drugs aren’t the only things responsible for helping patients heal and feel better. Medical devices are a huge category of medical care tools that often…
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3 Skills It Takes to Succeed on the Regulatory Affairs Career Track

Regulatory affairs is a relatively new and demanding career. It requires extensive knowledge of the business, legal, and pharmaceutical aspects of products in development, so that projects can be operated…
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A Guide to Global Pharmaceutical Regulations for Regulatory Affairs Students

Today’s pharmaceutical industry is very much a global market. While traditional economic powers like the United States remain leaders in the field, new drug development, manufacturing, and trade is now…
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