LMP 2345: Procurement, Privacy, and Regulatory Affairs

Type: Module

Credit: 0.25 FCE

Overview

This is a module and counts as 0.25 FCE.

Learning outcomes

At the end of this module students will be able to: 

  • Define privacy and demonstrate how it affects health information.
  • Define procurement and describe how it works in hospital contexts.
  • Communicate the purpose and significance of regulatory standards in healthcare.

Description

Privacy: Students will be introduced to the privacy legislation applicable in Ontario and Canada, including the Personal Information Protection and Electronic Documents Act (PIPEDA), the Ontario Personal Health Information Protection Act (PHIPA), and the Digital Privacy Act (DPA) to understand the requirements of these pieces of legislation.

Procurement: Unlike in a direct-to-consumer business model where a company’s customer is also the purchaser and likely end-user of a product, engaging with a healthcare system is vastly different. Students will be introduced to the concept of supply chain management, (i.e. the processes that manage the flow of goods and services, information and dollars between companies/suppliers, their customers, and end-users), will have an opportunity to explore the challenges of iterating a product through proof of concept, piloting, and early adoption, and will emerge with a deeper understanding of the importance of clearly identifying the customer, payer, and end-user for a product or service.

Regulatory Affairs: Students will be introduced to the regulatory lifecycles of medical devices through sessions led by domain experts and will address how a variety of standardized practice guidelines, including good laboratory practices (GLPs), good clinical practices (GCPs), good manufacturing practices (GMPs), and quality systems regulations (QSPs), dictate the types of data required for quality review and approval of regulatory submissions.

Enrollment

Students are required to complete eight modules (0.25 FCE each) spread out within 2 years of study. Students may enroll in modular courses using ACORN. The modular schedule will be emailed to students prior to the start of each semester. Modules offered outside of the program are also permitted such as ones offered by the Institute of Medical Science (IMS).
 

Teaching team

Dr. Gabriella Chan

Gabriella is a lawyer, scientist, and entrepreneur. She advises individuals, startup ventures, established companies, and stakeholders in the life sciences and health technology sectors. She works closely with world-renowned clinicians and researchers to commercialize academic inventions. Gabriella is an engaging educator. Her breadth of legal knowledge and real world start up experience offer invaluable perspectives on the ethically sound translation and commercialization of academic inventions. At the TRP, Gabriella is the Course Director for Modules in Translational Research, and she is the Instructor for the Intellectual Property module and the Procurement, Privacy, and Regulatory Affairs module.