Accredited by IACET/ANSI
The goal of this course is to provide you with an overview of the Regulatory Affairs function within a pharmaceutical company, both domestically and internationally. The module will discuss the different filings and consideration for medical devices, as well as pharmaceuticals in the United States and in the international community.
4.7 | (500 + Graduates)
1 Modules
6 Months Access
100% Online & Self Paced
24/7 Live Chat
Total Price : $3958.98
Buy all together : $ 3958.98
Regulatory Affairs & Medical Devices
Describe regulatory affairs for medical devices
Clearance vs Approval
Compare and contrast clearance versus approval
510(k) & IDE
Define a 510(k) & identify an IDE and the different types
Regulatory Affairs International
Evaluate the medical device classifications and regulatory affairs for the US, Canada, and the EU
OPDP
Describe the role of The Office of Prescription Drug Promotion (OPDP)
Users
Countries
Companies
Module 1
The goal of this course is to provide you with an overview of the Regulatory Affairs function within a pharmaceutical company, both domestically and internationally. The module will discuss the different filings and consideration for medical devices, as well as pharmaceuticals in the United States and in the international community including Canada and the EU.
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