Post Graduate Diploma In Regulatory Affairs In Canada

Last Updated on August 29, 2022 by Smile Ese

Post Graduate Diploma In Regulatory Affairs In Canada a one-year program for individuals, who want to enhance their professional knowledge in the field of Regulatory Affairs. The aim of this course is to fill the gap between prequalifications with several years of experience in a regulatory affairs and related technical fields or those recent graduates who wish to interface with the pharmaceutical industry or other stakeholders aiming to manage, maintain and expand product licenses. You will gain an understanding of global market access and regulatory issues, advanced regulatory functions like International Mutual Acceptance Of Data (IMAD), Global Harmonisation Task Force (GHTF) guidelines, pharmacovigilance systems as well as global standardisation initiatives promoting good clinical practice (ICH) and good laboratory practice (GLP).

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Post Graduate Diploma In Regulatory Affairs In Canada

Regulatory Affairs

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Sept 2022 – Aug 2023 Sept 2021 – Aug 2022Program Code: 07721Credential: Ontario Graduate Certificate Program Length: 3 semesters

Program Overview

Humber’s Regulatory Affairs graduate certificate program equips graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This online program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, health products, medical devices, biotechnology industries, food industries and other sectors that require a regulatory component. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related and consumable products. 

The importance of internationally harmonized regulations and future trends in the industry is examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), good documentation practices (GDP), the International Organization for Standardization (ISO), the Canadian Food and Drugs Act (CFDA), the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines.

Teamwork and communication skills are reinforced throughout the program, and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; assembling documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and linking the federal government and provincial formularies.

Program Delivery: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous remote classes. A work placement occurs in Semester 3 and is in-person.

This program is not available to international applicants.

Work Placement

Following two online academic course-based semesters, students complete a three-month (450 hours) work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Work placements are conducted in a wide range of organizations such as pharmaceutical, natural health products (NHP), medical device and biotechnology companies, as well as contract research organizations, hospitals, government agencies/departments and scientific institutions.

To progress into Semester 3, students must have successfully completed the first two semesters. During Semesters 3, students complete their learning at placement sites, and assessments are carried out by assigned supervisors at the site of placement. While Humber does assist students in finding their placements by working with industry partners to identify openings, students are responsible for finding their own work placement that is aligned with learning outcomes of our program.

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The Humber Advantage 

Industry Recognition

Every year our program receives excellent feedback from the industry regarding the professional preparation of the graduates and the content of the program; our graduates are an important resource for the industry. This is an outcome of our ongoing efforts to ensure that students have a solid understanding of regulatory affairs and field-specific knowledge.

In the Industry

Regulatory Affairs Specialists help the government and businesses to ensure that product development, manufacturing, and marketing practices meet government standards and ensure products are safe for public use. Regulatory affairs is a mandatory and necessary undertaking (ethically and regulatorily) in development, inspection, quality assurance, and safety assessment of new and existing consumable, therapeutic, and diagnostic products.

An Education in High Demand

The medical, pharmaceutical, food, and natural products industry is facing constant development. As a society focused on health and wellness as well as safety and efficacy much attention is being given to the safe development of new interventions, supplements, and drugs as well as the improvement of society’s overall health and wellbeing. Comprehensive training combined with work experience and previous degrees make Humber students highly marketable.

The Humber Experience

Superior Program Design

The Regulatory Affairs Graduate Certificate program at Humber is strategically designed, developed and delivered with high efficiency, during the first two semesters of the program. Subsequently, theoretical learning is extensively applied through hands-on experiences during the 3rd semester, including a 450 hours internship placement.

The fundamental skills are taught, developed, and reinforced throughout the one-year comprehensive program. Work ready graduates are developed in this program to confidently transition into the workforce.

The Right Fit

If you are policy and guidelines-oriented, self-regulated, have collaborative interpersonal skills and enjoy critical thinking, the Regulatory Affairs program and a career in this field may be for you.

Mission Statement

It is our vision and mission to offer our learners the means to excel in the field of Regulatory Affairs by providing industry relevant professional, technical, theoretical, and hands-on experience. We strive to develop work ready learners upon graduation through a collaborative partnership between students and the program. The internship component of this program, which follows two academic semesters, provides students a practical environment and offers ample opportunities to integrate theoretical learning into real industry hands-on experience. Additionally, the internship placement will provide students an opportunity to expand their professional network through interaction with peers, faculty and colleagues. It is our hope that upon graduation students will effectively and confidently transition to work force, related to their field of study.

Your Career

Our graduates typically pursue careers in the regulatory affairs departments in pharmaceutical, medical devices, biotechnology, consulting, inspection and quality assurance agencies, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.

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Program Availability

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Start dates between Sept 2022 – Aug 2023

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quality assurance and regulatory affairs courses in canada

Program Overview

This innovative program exposes students to real-world developments in the Food, Cosmetics and Pharmaceutical industry. QA/RA students gain a practical understanding of the quality systems such as GMP, HACCP, BRC and SQF as well as various regulatory strategies and submission process.

With faculty drawn from the industry, the networking opportunities are tremendous. Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, including quality assurance and control, regulatory science, R&D, manufacturing and validation, product development, safety, sanitation, clinical research, medical affairs and pharmacovigilance, biotechnology and generic drugs, medical devices and combination products, and marketing and sales.

AAPS offers highly flexible and convenient scheduling options. Students may start program every month and also can attend weeknight courses.

Career Opportunities

Graduates of the Quality Assurance and Regulatory Affairs – Food, Pharma and Cosmetics Post-Graduate Diploma Program may work for pharmaceutical, cosmetics or food manufacturing companies. QA professionals are consistently in demand across all three industries in Canada, as their sign-offs are required prior to releasing commercial products. Trained and qualified RA professionals are in demand for pharmaceutical, biotech, medical device and natural health product companies as they are needed to navigate the intricacies of regulatory submissions for new products.

AAPS graduates have been hired as:

  • Quality Assurance Associate/Technician
  • Auditor/Inspector
  • Technical Writer
  • Document Reviewer
  • Regulatory Affairs Associate
  • Regulatory Compliance
  • Regulatory Operations Associate

Certifications

Graduates will receive a Post-Graduate Diploma on Quality Assurance and Regulatory Affairs – Food, Pharma and Cosmetics. This program is approved as a vocational program under the Private Career Colleges Act, 2005. The Private Career Colleges Branch is part of the Ministry of Colleges and Universities and the Superintendent of Private Career Colleges is an appointed position by the Minister of Colleges and Universities.

masters in regulatory affairs

Learn About the Master of Science Degree in Regulatory Affairs and Quality Assurance (RAQA)

The first university to develop a graduate program in Quality Assurance and Regulatory Affairs, Temple School of Pharmacy (TUSP) continues to set the gold standard in this dynamic professional discipline. Since 1968, TUSP has remained in the forefront of industry education, offering more courses in Regulatory Affairs and Quality Assurance than any other similar graduate program.  Each year we continue to add and refine the RAQA curriculum to incorporate the latest trends in regulatory sciences.

RAQA courses expose students to real-world developments in the pharmaceutical industry, from current quality practices to the latest trends in domestic and global regulation.  Throughout their course of study, RAQA students gain a greater appreciation for benefit-risk assessment, regulatory intelligence, data mining and statistical relevance, and the complexities of blending pharmaceutical and regulatory science on a global scale.

The majority of students are from the industry, representing the world’s foremost pharmaceutical, device, and biotechnology companies.  Their experience and knowledge vary considerably:  some are just starting their careers, while others have been involved in industry for thirty years or more. 

With students and faculty drawn from more than 300 companies, the networking opportunities are tremendous.  Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, including quality assurance and control, regulatory science, R&D, manufacturing and validation, clinical research and trials, medical affairs and pharmacovigilance, biotechnology and generic drugs, medical devices and combination products, and marketing and sales. 

Students from the cosmetic, chemical, healthcare and food industries also participate to gain a deeper understanding of quality practices and regulatory compliance.

The pioneer in this educational discipline, TUSP offers highly flexible and convenient scheduling options.  Students may start or end the program in any semester (Fall, Spring or Summer) and also can attend weeknight or weekend courses. Over 50 courses are also offered in an online format.

In addition to the M.S. in RAQA, students may pursue various certificate programs in Regulatory Affairs and Quality Assurance, almost all of which can also be pursued online.  Certificates provide an excellent way for students to earn well-recognized credentials in a specific industry specialty.

Students can:

  • Pursue individual courses to enhance their knowledge of a specific area
  • Earn specific certificates to gain credentials in a specialty
  • Pursue the M.S., either concentrating their electives in a given specialty or selecting courses from multiple industry disciplines (quality, regulatory, clinical, pharmacovigilance, medical devices, etc.)
  • Apply credits earned in a certificate towards the M.S.
  • Pursue additional advanced certificates after receiving the M.S.