Regulatory Affairs: CMC

Regulatory Affairs: CMC

This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC changes that are required for amendments, and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC for IMPD. The best choice for future certification and career promotion.

In general, despite regional differences, most health authorities expect an increasing amount of information and a depth of technical knowledge to be provided in clinical trial applications, CTD/eCTD dossiers. Regulatory requirements for CMC information, history of CMC, guidance, and tips are provided within the scope of this course.

Creator of this course - D. Ladanovska (RA Consultant, Head of RA)

Speaker of this course - Liyonish (US singer, actress, speaker)

Upon completion of this course, you will be able to:

• Identify the CMC information required for submissions to support clinical studies and marketing applications;

• Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section;

• Identify CMC changes that require agency notification;

• Explain different types of postapproval submissions;

• Describe the use of Drug Master Files (DMFs);

• Use tips for the IMPD Quality part;

• Be an expert in the main CMC-guidances.

With a calm invited narrator's voice in this course, be ready to expand your knowledge and be prepared for future career challenges and winnings. Let's go!

Chemistry, Manufacturing and Controls. From RA History to Submission.

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What you will learn

• Identify the CMC information required for submissions to support clinical studies and marketing applications
• Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section
• Identify CMC changes that require agency notification

Rating: 3.13333

Level: All Levels

Duration: 1 hour

Instructor: Dasha Ladanovska