The Regulatory Affairs Expert Program (RAEP) Certificate
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.
4.6
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500 + Graduates
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All of the ACMA's programs are accredited by IACET/ANSI
$799.99
4.6
Earn an Accredited Certificate
Gain a Competitive Edge
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Flexible and Self-Paced
Approx. 4 Hours
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About the Course
Global Regulatory Strategy for Medical Devices
Global Regulatory Strategy for Pharmaceuticals
Medical Devices: Definition & Lifecycle
Pharmaceuticals: Definition & Lifecycle
Role of the Regulatory Professional
Ethics
Course features include
Flexible, Online, and Self-Paced Design for Busy Professionals
Pre/Post-Test Knowledge Check and Cases Studies Included To Track Your Mastery
24/7 Dedicated Live Chat Support
Learn On The Go! Mobile and Tablet Friendly Format
Topics Covered
Clinical development regulatory affairs
The role of regulatory affairs in advertising & promotion
The difference between clearance and approval
Types of regulatory submissions and applications
U.S. drug & biologics labeling, advertising & promotion
The regulatory system in Europe & Canada
Common FDA forms used by regulatory affairs