Regulatory Affairs: CMC

Offered byUDEMY

Regulatory Affairs: CMC
at
UDEMY
Overview

Chemistry, Manufacturing and Controls. From RA History to Submission

Duration	1 hour
Total fee	₹649
Mode of learning	Online
Credential	Certificate

Regulatory Affairs: CMC
at
UDEMY
Highlights

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Regulatory Affairs: CMC
at
UDEMY
Course details

Skills you will learn

Marketing

Who should do this course?

Regulatory Affairs Officer
Regulatory Affairs Associate
Regulatory Affairs Specialist
Regulatory Affairs Manager
Quality Control Manager
Head of Regulatory Affairs
Regulatory Writer

What are the course deliverables?

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.

More about this course

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
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

Regulatory Affairs: CMC
at
UDEMY
Curriculum

Introduction

What is CMC

Regulatory History of CMC

EU Legislation

ICH

Regulatory Affairs: CMC
at
UDEMY
Faculty details

Dasha Ladanovska

Master of Science. Head of Regulatory Affairs. Several years of efficient development regulatory documents and professional assessment in regulatory affairs. As Regulatory Affairs Specialist (GLOBAL) - registration of original biological products, generics, veterinary products in 27 countries around the world (Europe, LATAM, ASEAN, MENA, Africa, CIS...).