What you'll learn

Understand Regulatory Frameworks
Navigate the Health Canada Website Effectively
Learn how to apply Good Manufacturing Practices (GMP)
Understand accelerated approval options such as Priority Review and Extraordinary Use New Drugs pathways

Requirements

Familiarity with drug development processes, clinical trials, or pharmaceutical manufacturing is helpful but not mandatory.
A general awareness of global or regional regulatory

Requirements

(e.g., FDA, EMA) can provide useful context.
Professionals working in regulatory affairs, quality assurance, clinical research, or drug manufacturing will find the course directly relevant to their work.
Access to the Internet and Basic Computer Skills
Even if you are new to the biotech or pharma industry, this course provides step-by-step guidance and assumes no prior expertise in regulatory affairs or Health Canada's processes. Enthusiasm to learn and explore the content is the only real requirement!

Description

Navigating the regulatory landscape is crucial for success in the biotech and pharmaceutical industries, and this course equips professionals with the skills to effectively utilize the Health Canada website. Designed for regulatory affairs specialists, quality assurance professionals, clinical researchers, and manufacturing teams, this course provides a comprehensive

Overview

of Health Canada's processes for clinical trials, drug submissions, and post-market

Requirements

. Learners will gain practical insights into Good Manufacturing Practices (GMP), Establishment Licensing, accelerated approval pathways, and risk management plans.Through step-by-step guidance, participants will learn how to locate key resources, stay updated on regulatory changes, and ensure compliance with Canadian drug regulations. This course highlights best practices for navigating regulatory pathways, accessing essential guidance documents, and efficiently handling submission documentation. Additionally, participants will explore strategies for post-market monitoring, risk communication, and safety reporting to maintain compliance throughout a drug's lifecycle.Whether you're a seasoned professional or transitioning into a regulatory role, this course empowers you to confidently navigate Health Canada's regulatory environment. By mastering these processes, you will contribute to safer, faster, and more effective drug approvals, benefiting both your organization and public health. This course is your gateway to regulatory success in Canada's biotech and pharma landscape. Good Luck!

Overview

Section 1: Introduction
Lecture 1 Introduction to the Course
Section 2: Health Canada Homepage:
Lecture 2 Get Familiar with the Health Canada Homepage:
Section 3: Biologics, Radiopharmaceuticals and Genetic therapies section
Lecture 3 Biologics, Radiopharmaceuticals and Genetic Therapies Section
Section 4: Legislation and Guidelines Section
Lecture 4 Legislation and Guidelines Section
Section 5: Drug Products Section
Lecture 5 Navigating the Drug Products Section
Section 6: Summary
Lecture 6 Course Summary
Individuals responsible for preparing and submitting clinical trial applications, drug submissions, and post-market reports in compliance with Health Canada regulations.,Professionals tasked with ensuring adherence to Good Manufacturing Practices (GMP) and maintaining high standards for drug safety, efficacy, and quality throughout the product lifecycle.,Those managing clinical trials and Investigator's Brochures, and ensuring trial data aligns with Health Canada's

Requirements

.,Teams working on drug fabrication, packaging, labelling, and licensing processes, who need to understand Establishment Licenses and Drug Identification Number (DIN) applications.,Professionals focusing on post-approval changes, risk communications, and safety monitoring for marketed products.,Individuals transitioning into regulatory affairs, compliance, or quality assurance who seek to build foundational knowledge of Health Canada's regulatory landscape.

Homepage:

https://www.udemy.com/course/navigating-health-canada/

Udemy – Navigating The Health Canada Website Fast Download
Udemy – Navigating The Health Canada Website Full Download