Regulatory Affairs Series

Introduction to Pharmaceutical Regulatory Affairs - Level 1

This course is specifically designed to accelerate students' understanding and education of Pharmaceutical Regulatory Affairs in a compact and easy to absorb format. The aim is to give a clear understanding of rules and regulations affecting pharmaceutical, biological, natural health products and medical devices. There is an in depth discussion of international food and drug laws, regulations and guidelines.

In module 3 the new drug development process and its role within the regulatory framework is discussed.

Purchase all 3 modules for $375 +HST (a saving of $30!) REGISTER NOW

Module 1 (PRA1008.1)

Session 1 - Health Care Products
Session 2 - Healthcare Products: Stages of Product Lifecycle
Session 3 - The Make-Up of Regulatory Affairs


Price: $135 +HST

Module 2 (PRA1008.2)

Session 4 - Regulatory System and Agencies - US FDA
Session 5 - Regulatory System and Agencies - Health Canada
Session 6 - Global Harmonization Efforts


Price: $135 +HST

Module 3 (PRA1008.3)

Session 7 - Pharmacovigilance
Session 8 - Types of Drug Submissions in Canada
Session 9 - Clinical Trial Applications
Session 10 - Post-Notice of Compliance Changes

Price: $135 +HST



Regulatory Affairs - Regulatory Submissions (PRA2008)

The second in our Professional Regulatory Affairs series, this course is designed to give students advanced-level knowledge of various regulatory submissions and requirements. The role of intellectual properties in the pharmaceutical drug development and regulatory submission is discussed in module 3

$270 course fee or $135 per module + HST REGISTER NOW

Module 1 (PRA2008.1) -
prerequisite none

PRA2008.1.1 - Common Technical Document (CTD)
PRA2008.1.2 - Clinical Trial Application (CTA)
PRA2008.1.3 - Investigational New Drug Applications (IND)

Price: $135 +HST

Module 2 (PRA2008.2) -
prerequisite module 1

PRA2008.2.1 - Submission for new Drugs – Canada
PRA2008.2.2 - Submission for new Drugs – US



Price: $135 +HST



Regulatory Affairs - Preclinical - Drugs (PRA2011)

The course objective is the learn about the requirements for Non-clinical studies in support of producing regulatory filings to proceed to human clinical trials. The documentation and study requirements will be reviewed in the context of global submission in the CTD format.

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Module 1 (PRA2011.1)

PRA2011.1.1 - Introduction & Regulatory Basis for Assessments
PRA2011.1.2 - Presentation & Format for Non-Clinical Data




Price: $135 +HST