BIO375H5 Lecture Notes - Lecture 1: Intellectual Property, Niche Market, Brainstorming
Document Summary
Email - bio375 with student number and name. Regulatory pathways during the development of a product: ex. Products need to be approved by the fda (food and drug administration) you have to take all of these ideas into consideration when making a biomedical product. You have a drug that can be used for a disease and you can try and file for a patent. Reimbursements: related to insurance and buyers at hospital. Regulatory pathways: example (510 k, pm8?) talk about this after the first test. Talk about class 1, class 2 and class 3. 10 student per group ( 10 minutes long presentation, 5 minutes for questions) Not tutorial after the first and second term test. Npd ( new product development): based on the presentation, each group evaluates the group presentations. 4 lectures, the required readings for the lecture, and the tutorials. Don"t need to know anything from term test 1.
