Regulatory Affairs

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Courses - May 2023

Level 1

Course details

Conestoga 101
CON0101

Description: This self-directed course focuses on introducing new students to the supports, services, and opportunities available at Conestoga College. By the end of this course, students will understand the academic expectations of the Conestoga learning environment, as well as the supports available to ensure their academic success. Students will also be able to identify on-campus services that support their health and wellness, and explore ways to get actively involved in the Conestoga community through co-curricular learning opportunities.

Hours: 1
Credits: 0
Pre-Requisites:
CoRequisites:

Regulation Theory and Design
LAW8280

Description:

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 products and health care. Students examine the importance of regulations in a variety of industries, review various regulatory agencies regulating these fields, and learn about different stages of product development (non-clinical, clinical, product marketing application and post-marketing activities) and health care service regulation. By examining Canadian, US, and international regulations students learn to apply regulation principles to new or evolving product development and production, and health service regulatory practice.

Hours: 42
Credits: 3
Pre-Requisites:
CoRequisites:

Project Management of Regulatory Submissions
MGMT8920

Description:

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

Description:

This course introduces the concept of Quality Assurance as it applies to regulatory affairs. By examining Quality Assurance theory, students learn to apply best practices in Quality Assurance to pharmaceutical, medical device, food or natural product manufacturing, and health care. Students learn to apply Standard Operating Procedures (SOP) throughout the lifecycle of product and service development to ensure regulatory compliance.

Hours: 56
Credits: 4
Pre-Requisites:
CoRequisites:

Preparing Quality Regulatory Submissions
QUAL8420

Description:

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

Description:

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

Description:

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
CDEV8130

Description: This course focuses on career management skills needed to navigate the evolving workplace. Students will evaluate their skills, attitudes, and expectations within their chosen careers and explore emerging trends in the workplace. Students will refine their networking strategies and create marketing documents to position them for success. Mock interviews will provide the opportunity for practice, feedback, and reflection as students prepare for future interviews. Students will explore communication strategies that support workplace success and advancement. By the end of this course, students will have created a personalized career management plan.

Hours: 28
Credits: 2
Pre-Requisites:
CoRequisites:

Regulatory Submissions: Pre-Market
MGMT8950

Description:

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

Description:

Following the release of a new product or service on the market, the evaluation and post-market analysis help ensure the safety and success of new products or services. In this course the students continue to build skills in managing regulatory submissions by examining approaches and practices to support post-marketing analysis and regulatory compliance through the life cycle of the product or service.

Hours: 56
Credits: 4
Pre-Requisites:
CoRequisites:

Strategic Planning and Regulatory Intelligence
MGMT8970

Description:

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

Description:

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

Description:

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