Regulatory Affairs Expert Program

Certificate Course
|
IACET Logo

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)

$959.99
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1 Modules

6 Months Access

100% Online & Self Paced

24/7 Live Chat

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Learning Objectives

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)

Master These Skills

Regulatory affairs functions
Medical devices
510(k)
IDE
Medical device classifications
US regulatory affairs
Canada regulatory affairs
EU regulatory affairs
OPDP
Regulatory Affairs Expert Program

All ACMA certifications are accredited by IACET/ANSI

25k+

Users

80+

Countries

250+

Companies

Module Breakdown

Diagnostics Industry

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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