Business of Biotech 201: From Molecule to Market, R&D and Regulatory Considerations

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Description

This MassBioEd online course builds on the business overview of “The Business of Biotech 101” course. For those considering careers in the biopharma space or transitioning from the science and technical aspects of the industry, this course delivers an outline of Clinical, Regulatory, and Quality considerations and practices. Students will be provided foundational information about the BioPharma industry and regulations via instruction, storytelling, and breakout group discussions. Industry ethics will be discussed, with emphasis on historical precedents. We will explore the decision-making process by touching on relevant topics such as market share and phases of development.

Guest speakers will be invited to represent specific considerations and to showcase their roles and experiences. We will review Research and Development processes and considerations from pre-clinical through market approval.

Schedule

Monday, April 5th, 2021 03:00 PM – 05:30 PM EST
Wednesday, April 7th, 2021 03:00 PM – 05:30 PM EST
Friday, April 9th, 2021 03:00 PM – 05:30 PM EST

Agenda

Session 1:
The History of Regulations
Industry Overview
Research & Development: An Overview of R&D

Session 2:
Roles in Clinical Trials
Marketing Considerations

Session 3:
Compliance via Regulatory & Quality Processes