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Thursday, March 23, 2017
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Essentials in US Regulatory Affairs Professional Certification Program (PRA00B1)

Certification Training Duration: 5.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 6
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $579.00

Description: This program includes essentials for human medicinal products in the EU and US, preparing submissions in the Common Technical Document (CTD) Form, and the NDA Process (requirements for obtaining approval for a new drug in the USA).
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

BioPharma Institute LogoThe Essentials in US Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:



Regulatory Affairs: Essentials for Human Medicinal Products – EU and US:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. When changes to regulations and procedures occur, the module is updated and hence serves as a handy reference tool allowing new as well as experienced users to keep up to date with the broader picture of the regulatory affairs environment.

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The CTD is the mandatory format for regulatory submissions in the European Union, Japan, Canada and Australia and strongly recommended in the USA. It is accepted widely elsewhere. This module explains the rationale for the CTD and provides detailed guidance on its structure and format. Related documents such as Drug Master Files and Certificates of Suitability are also dealt with.

Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA. For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable? This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.


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