Good Manufacturing Practices (cGMP) - Intermediate

Regulatory Submissions

Bringing a drug product to market is a complex and nuanced process. In this course, learners will be immersed in a comprehensive overview of the regulatory approval process for drug products. The stages, roles, and expectations involved in successfully guiding a product from development through to market launch will be explored, including understanding regional regulatory differences and central role of the Common Technical Document in the process. 

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CEU Credits: 0.1
Course Code: ELM-961
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 08/06/2024

Curriculum for this course

Course Introduction
Roles
Regulatory Agencies
Submission Process
Amendments
Global Drug Approval Pathways
Application Content and Evaluation
Alternate Submissions
CTD Purpose
CTD Structure
Expansion into New Markets
Mutual Recognition Agreements
Reliance and Recognition
Test your Knowledge!

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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