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Learn how to organize your medical product design teams to meet the stringent FDA requirements and Regulatory Affairs. This course has two phases, concept review and evaluation review that provides a baseline knowledge on the role of regulatory a...
... Section 1) Quarter: FALL 2021 Instructor Dr. Darin S. Oppenheimer is Executive Director of the Drug ... Center of Excellence, focusing on Medical Devices and Combination Products at Merck, based in Upper Gwynedd, PA ...
Product approval is a crucial milestone in a product’s lifecycle, after which, the marketing phase begins and post-approval compliance requirements commence. This course explores the FDA regulatory requirements for drugs and biologics following ...
... Section 1) Quarter: SUMMER 2021 Instructor Dr. Darin S. Oppenheimer is Executive Director of the Drug ... Center of Excellence, focusing on Medical Devices and Combination Products at Merck, based in Upper Gwynedd, PA ...