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View our Virtual tourCourses - January 2025
Level 1
Course details
Conestoga 101
CON0101
- Hours: 1
- Credits: 0
- Pre-Requisites:
- CoRequisites:
Regulation Theory and Design
LAW8280
Regulation plays a key role in protecting public safety. In this course, students develop an understanding of regulation theory and design in a variety of industries, including pharmaceutical, medical devices, food, natural health products and health care. Students examine the importance of regulations in Canada, US, and Europe by reviewing regulatory agencies overseeing these industries, and learn about different stages of product development in the pharmaceutical industry (non-clinical, clinical, product marketing application and post-marketing activities) and health care service regulation. Students learn to apply regulatory principles to products across their life cycle and production, and health service regulatory practice.
- Hours: 42
- Credits: 3
- Pre-Requisites:
- CoRequisites:
Project Management of Regulatory Submissions
MGMT8920
In this course students acquire project management skills essential to project success in a regulatory environment. By applying principles, approaches and tools of effective project management and collaboration, students learn how to effectively plan and execute projects.
- Hours: 42
- Credits: 3
- Pre-Requisites:
- CoRequisites:
Regulatory Affairs and Quality Assurance Foundations
QUAL8390
This course provides a comprehensive introduction to Quality Assurance (QA) as it applies to regulatory affairs in industries such as pharmaceuticals, medical devices, food, natural products manufacturing, and healthcare. Students will learn to implement and maintain Quality Management Systems (QMS) and develop Standard Operating Procedures (SOPs) to ensure regulatory compliance. Key QA tools such as Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPAs), and the change control process will be covered, along with developing essential skills for conducting inspections and audits. By mastering these concepts, students will be equipped to ensure the production of safe, effective, and compliant products and services.
- Hours: 56
- Credits: 4
- Pre-Requisites:
- CoRequisites:
Preparing Quality Regulatory Submissions
QUAL8420
In this course students will learn how to deliver high quality scientific and technical information concisely and accurately to create high quality regulatory submissions using appropriate formats and graphical support. Students will learn how to leverage their knowledge of regulatory stakeholders to gain buy-in and delivering effective industry-specific materials to a variety of regulatory agencies.
- Hours: 42
- Credits: 3
- Pre-Requisites:
- CoRequisites:
Introduction to Clinical Research in Regulation
RSCH8180
Regulation plays a key role in protecting public safety. In this course, students develop an understanding of the regulatory framework for conducting clinical research with an emphasis on the ICH, GCP, and CFR guidelines. Students learn the role that different regulatory agencies play in the approval of new drugs, devices and procedures, such as Health Canada, FDA, EMA, etc. Using the knowledge of appropriate clinical trial regulations, the students build skills to appropriately support the clinical research application process and successful completion without endangering human participants.
- Hours: 42
- Credits: 3
- Pre-Requisites:
- CoRequisites:
Scientific Assessment and Data Analysis
RSCH8190
Informed decision making requires a set of skills in interpreting and evaluating data. In this course students build critical thinking skills necessary for examining clinical and nonclinical data and its implications for decision making in regulatory settings. Students learn different types of statistical analyses and apply appropriate statistical concepts to data analysis.
- Hours: 56
- Credits: 4
- Pre-Requisites:
- CoRequisites:
Level 2
Course details
Career Management
CDEV8132
- Hours: 28
- Credits: 2
- Pre-Requisites:
- CoRequisites:
Regulatory Submissions: Pre-Market
MGMT8950
Managing regulatory submissions through pre-market activities is a critical component of regulatory affairs. Students build skills necessary to support regulatory submissions sequencing for new product or service approval. Students learn to apply appropriate regulatory requirements to product or service development and marketing, review and prepare documentation and guide testing in compliance with regulations.
- Hours: 56
- Credits: 4
- Pre-Requisites:
- CoRequisites:
Regulatory Submissions: Evaluation and Post-Market Analysis
MGMT8960
Following the release of a new product in the market, the evaluation and post-market analysis help to maintain the Quality, Safety, and the efficacy of marketed products. In this course the students continue to build skills in managing regulatory submissions by examining tools, approaches and practices to support post-marketing analysis and regulatory compliance through the life cycle of the product.
- Hours: 56
- Credits: 4
- Pre-Requisites:
- CoRequisites:
Strategic Planning and Regulatory Intelligence
MGMT8970
Regulatory specialists evaluate the regulatory environment to provide advice throughout the life cycle of the product. In this course students learn to conduct strategic planning, including risk/benefit analysis, safety and efficacy testing, and evaluating regulatory outcomes and decisions. Students examine the impact of health equity on diverse communities and apply health equity principles to regulatory planning. Students learn the foundations of providing regulatory intelligence to develop local, regional, and global regulatory strategies.
- Hours: 42
- Credits: 3
- Pre-Requisites:
- CoRequisites:
Quality Assurance in Regulation
QUAL8400
Quality assurance is a key activity in the regulatory processes. In this course students examine the applications of quality assurance principles and practices as they apply to products, processes, technologies and facilities. Students learn to apply concepts of regulatory compliance and monitoring to support development, manufacturing and operational processes.
- Hours: 56
- Credits: 4
- Pre-Requisites:
- CoRequisites:
Regulatory Affairs Capstone
RSCH8200
Using a real-world example from a pharmaceutical, device, food, agricultural, natural product, biotechnology or health care industries, student apply regulatory management skills to prepare the regulatory submission and regulatory management plan.. Students apply knowledge and skills in regulation, strategic planning, quality assurance, audit and inspection processes to create a viable regulatory submission and management plan.
- Hours: 84
- Credits: 6
- Pre-Requisites:
- CoRequisites:
Program outcomes
- Design and develop processes and procedures that contribute to the creation of regulatory strategies related to a product's life cycle and ensure compliance to regulations.
- Execute quality assurance and quality control processes to ensure conformance to Canadian, US and international harmonization standards and practices.
- Prepare, manage and maintain regulatory packages and reports in compliance with industry-specific regulations and internal policies.
- Use a wide range of data analysis methods to support decision making processes.
- Manage and monitor change in regulations and their potential impacts on products or services and implement the respective corrective and mitigating strategies.
- Conduct an industry and socio-economic impact analysis regarding the introduction of a new product, service or policy.
- Work collaboratively with product development teams, applying leadership techniques to complete projects in accordance with project timelines.
- Identify and apply regulatory strategies that contribute to and promote health equity in diverse communities using regulatory intelligence and strategic vision
- Participate in professional development activities to maintain currency in a changing regulatory affairs landscape.
- Present technical information to a variety of stakeholders in accordance to regulatoryrequirements across the life cycle of a product or service